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SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA) VACANCIES
SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA)
The South African Health Products Regulatory Authority (SAHPRA), is the National Medicines Regulatory Authority established in terms of the Medicines and Related Substances Act, 1965, (Act No. 101 of 1965) as amended, to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances, clinical trials and medical devices, and related matters in the public interest.
Re- Advertisement of Ref no:. SAHPRA 026-2023. Candidates who previously applied are encouraged to reapply.
MEDICINES REGISTRATION OFFICER
PHARMACEUTICAL POST- REGISTRATION EVALUATION MANAGEMENT X3
SALARY: R 657 376.00 – R834 199.00 per annum. (TOTAL COST TO COMPANY)
(Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service.
Ref No.: SAHPRA 075/2023
CENTRE: Pretoria
Requirements: Matric certificate and appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) or / Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA. A relevant Master’s qualification will be an added advantage.
Grade 1 – 4-year Bachelor of Pharmacy Degree NQF or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of five (5) of experience in pharmaceutical regulatory environment or related medicine production quality assurance sector.
Grade 2 - 4-year Bachelor of Pharmacy Degree NQF level 8 as recognised by SAQA and registration as a Pharmacist with South African Pharmacy Council (SAPC) and minimum of three (3) years of experience in pharmaceutical regulatory environment or related medicine production quality assurance sector or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of ten (10) years of experience in pharmaceutical regulatory environment or related medicine production quality assurance sector
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES: *Knowledge and application of the Medicines and Related Substances Act (101 of 1965) as amended and its related Regulations and Guidelines. * Knowledge of technical aspects for evaluation of quality and efficacy (bioequivalence) of medicines. * Computer literacy and sound working knowledge of computer software packages. *Technical and scientific aspects of medicine regulation. *Evaluation guidelines as prescribed by the relevant regulatory authorities. *Planning and organisational skills. *Leadership skills. *Coordination skills. *Diversity management. *Time management. *Good telephone etiquette. *Supervisory skills. *Comprehensive knowledge and understanding of relevant legislation, protocols, standard operating procedures and work instructions. *Performance measurement skills. *Self-motivated and able to work independently. *Ability to manage a variety of cross-functional team members. *Competent in problem solving and team building. *Information evaluation. *Decision making. *Objectivity. *Resilience. *Communication skills (verbal, written, negotiation, conflict management, presentation). *Interpersonal skills. *Assertiveness. *Ethical behaviour. *Customer service. *Planning and organising skills. *Team management.
RESPONSIBILITIES & DUTIES: Evaluation of quality variations for small molecule product applications and peer reviewing of these applications. Write reports and draft query and approval/rejection letters after evaluation: • Evaluation of Type I and II quality variation applications in accordance with EMA variation guidelines, ICH requirements and minimal international standards. • Prepare a detailed scientific evaluation report in accordance with the Good Review Practice guide and competency assessment rubric. • Peer-review reports done by other reviewers in accordance with the Good Review Practice guide and competency assessment rubric. • Do a QA check or technical discussion on evaluation reports, in cases where this is needed. • Prepare report for the internal peer review or technical discussion meetings and where necessary present at advisory committee. • Prepare draft query, approval, or rejection letter to the applicant, whichever is relevant. Check letters for correctness for technical requirements and for spelling, grammar and sentence construction.
Technical screen and evaluate the quality and efficacy (Bio-equivalence) aspects of the quality variation applications for the registered medicines: • Complete technical screening of all new variations received in accordance with technical screening SOP and record on the tracker. • Generate screening/evaluation query letter for relevant technical queries. • Complete technical screening check on the validation template and draft templates for evaluators. Save these on the shared drive in the application specific folder. • Complete admin screening and verify fees, by calculating required fees. Record the fees paid as per the POP in the dossier, in the tracker and communicate shortfalls via unit email. • Create POP folder on the shared drive for each new sequence and save POPs. • Update the tracker with the above information and the payments which were made in response to queries sent to the applicant.
Evaluate applicant responses and variations for the registered medicines: • Evaluate the quality and efficacy (Bio-equivalence) aspects of responses to queries on the variations to registered products, in line with Good Review Practice guide, ICH guidelines, EMA guidelines and other relevant international standards. • Generate detailed scientific evaluation reports in line with the Good Review Practice guide, ICH guidelines, EMA guidelines and other relevant international standards. • Prepare report for the internal peer review and where necessary present at advisory committee. • Prepare approval/query/rejection letter as applicable.
Form part of technical working groups or special projects and provide support to the Advisory Committees: • Participate in special projects and Pre and Post registration working groups as required and engage in technical scientific discussions on ongoing applications under review. • Lead and manage (including organising) assessments peer review and discussion working groups, where relevant, and do research if necessary to contribute to the discussions. • Compile discussion documents, including agendas, minutes and actions items, and reports. Update these regularly as necessary. Record meetings and save in the unit shared drive. • Take comprehensive notes of discussions of relevant discussions in meetings and update documents regularly. Implement any scientific decisions in future assessments. • Participate in international scientific regulatory forums and discussion groups including ICH, IPRP and WHO, as relevant and when nominated. • Review existing SOPs and update when necessary. • Provide comments and corrections to SOPs which are currently under review. • Create new SOPs where relevant or as instructed by the manager. • Provide regular work-plans and output to the unit manager (qualitative and quantities report). • Perform any other related duty as requested by manager/senior manager.
Risk Management and Audit: • SOPs and SAHPRA, ICH, EMA and other relevant guidelines must be adhered to. • Create and maintain data bases as needed. • Respond to relevant queries timeously. • Respond to applicants’ questions pertaining to recommendations and any other related concerns. • Attend relevant training as may be necessary and give feedback to the unit after attendance. • Provide training and mentorship for other staff members if relevant. This includes technical scientific trainings as well as practical administrative trainings. • Keep updated on regulatory updates and latest scientific discussions and alerts with regards to medicines quality, safety and efficacy
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names and email addresses of 3 referees and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
• Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: The closing date has been extended to the 12 January 2024 at 16H00. SAHPRA apologies for any inconvenience caused.
Re- Advertisement of Ref no:. SAHPRA 026-2023. Candidates who previously applied are encouraged to reapply.
MEDICINES REGISTRATION OFFICER
PHARMACEUTICAL POST- REGISTRATION EVALUATION MANAGEMENT X3
SALARY: R 657 376.00 – R834 199.00 per annum. (TOTAL COST TO COMPANY)
(Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service.
Ref No.: SAHPRA 075/2023
CENTRE: Pretoria
Requirements: Matric certificate and appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) or / Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA. A relevant Master’s qualification will be an added advantage.
Grade 1 – 4-year Bachelor of Pharmacy Degree NQF or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of five (5) of experience in pharmaceutical regulatory environment or related medicine production quality assurance sector.
Grade 2 - 4-year Bachelor of Pharmacy Degree NQF level 8 as recognised by SAQA and registration as a Pharmacist with South African Pharmacy Council (SAPC) and minimum of three (3) years of experience in pharmaceutical regulatory environment or related medicine production quality assurance sector or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of ten (10) years of experience in pharmaceutical regulatory environment or related medicine production quality assurance sector
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES: *Knowledge and application of the Medicines and Related Substances Act (101 of 1965) as amended and its related Regulations and Guidelines. * Knowledge of technical aspects for evaluation of quality and efficacy (bioequivalence) of medicines. * Computer literacy and sound working knowledge of computer software packages. *Technical and scientific aspects of medicine regulation. *Evaluation guidelines as prescribed by the relevant regulatory authorities. *Planning and organisational skills. *Leadership skills. *Coordination skills. *Diversity management. *Time management. *Good telephone etiquette. *Supervisory skills. *Comprehensive knowledge and understanding of relevant legislation, protocols, standard operating procedures and work instructions. *Performance measurement skills. *Self-motivated and able to work independently. *Ability to manage a variety of cross-functional team members. *Competent in problem solving and team building. *Information evaluation. *Decision making. *Objectivity. *Resilience. *Communication skills (verbal, written, negotiation, conflict management, presentation). *Interpersonal skills. *Assertiveness. *Ethical behaviour. *Customer service. *Planning and organising skills. *Team management.
RESPONSIBILITIES & DUTIES: Evaluation of quality variations for small molecule product applications and peer reviewing of these applications. Write reports and draft query and approval/rejection letters after evaluation: • Evaluation of Type I and II quality variation applications in accordance with EMA variation guidelines, ICH requirements and minimal international standards. • Prepare a detailed scientific evaluation report in accordance with the Good Review Practice guide and competency assessment rubric. • Peer-review reports done by other reviewers in accordance with the Good Review Practice guide and competency assessment rubric. • Do a QA check or technical discussion on evaluation reports, in cases where this is needed. • Prepare report for the internal peer review or technical discussion meetings and where necessary present at advisory committee. • Prepare draft query, approval, or rejection letter to the applicant, whichever is relevant. Check letters for correctness for technical requirements and for spelling, grammar and sentence construction.
Technical screen and evaluate the quality and efficacy (Bio-equivalence) aspects of the quality variation applications for the registered medicines: • Complete technical screening of all new variations received in accordance with technical screening SOP and record on the tracker. • Generate screening/evaluation query letter for relevant technical queries. • Complete technical screening check on the validation template and draft templates for evaluators. Save these on the shared drive in the application specific folder. • Complete admin screening and verify fees, by calculating required fees. Record the fees paid as per the POP in the dossier, in the tracker and communicate shortfalls via unit email. • Create POP folder on the shared drive for each new sequence and save POPs. • Update the tracker with the above information and the payments which were made in response to queries sent to the applicant.
Evaluate applicant responses and variations for the registered medicines: • Evaluate the quality and efficacy (Bio-equivalence) aspects of responses to queries on the variations to registered products, in line with Good Review Practice guide, ICH guidelines, EMA guidelines and other relevant international standards. • Generate detailed scientific evaluation reports in line with the Good Review Practice guide, ICH guidelines, EMA guidelines and other relevant international standards. • Prepare report for the internal peer review and where necessary present at advisory committee. • Prepare approval/query/rejection letter as applicable.
Form part of technical working groups or special projects and provide support to the Advisory Committees: • Participate in special projects and Pre and Post registration working groups as required and engage in technical scientific discussions on ongoing applications under review. • Lead and manage (including organising) assessments peer review and discussion working groups, where relevant, and do research if necessary to contribute to the discussions. • Compile discussion documents, including agendas, minutes and actions items, and reports. Update these regularly as necessary. Record meetings and save in the unit shared drive. • Take comprehensive notes of discussions of relevant discussions in meetings and update documents regularly. Implement any scientific decisions in future assessments. • Participate in international scientific regulatory forums and discussion groups including ICH, IPRP and WHO, as relevant and when nominated. • Review existing SOPs and update when necessary. • Provide comments and corrections to SOPs which are currently under review. • Create new SOPs where relevant or as instructed by the manager. • Provide regular work-plans and output to the unit manager (qualitative and quantities report). • Perform any other related duty as requested by manager/senior manager.
Risk Management and Audit: • SOPs and SAHPRA, ICH, EMA and other relevant guidelines must be adhered to. • Create and maintain data bases as needed. • Respond to relevant queries timeously. • Respond to applicants’ questions pertaining to recommendations and any other related concerns. • Attend relevant training as may be necessary and give feedback to the unit after attendance. • Provide training and mentorship for other staff members if relevant. This includes technical scientific trainings as well as practical administrative trainings. • Keep updated on regulatory updates and latest scientific discussions and alerts with regards to medicines quality, safety and efficacy
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names and email addresses of 3 referees and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
• Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: The closing date has been extended to the 12 January 2024 at 16H00. SAHPRA apologies for any inconvenience caused.
Re- Advertisement of Ref no:. SAHPRA 046-2023. Candidates who previously applied are encouraged to reapply.
MEDICINES REGISTRATION OFFICER
CLINICAL POST REGISTRATION X3
SALARY: R 657 376.00 – R834 199.00 per annum. (TOTAL COST TO COMPANY) (Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service.
Ref No.: SAHPRA 071/2023
CENTRE: Pretoria
Requirements: Matric certificate and appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) or / an MBChB degree and registration as a Medical Officer with the Health Professional Council of South Africa (HPCSA) at NQF level 8 as recognised by SAQA. A relevant Master’s qualification will be an added advantage.
Grade 1 – 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) or / an MBChB degree and registration as a Medical Officer with the Health Professional Council of South Africa (HPCSA) at NQF level 8 as recognised by SAQA plus a minimum of three (3) years of clinical experience of which one (1) in regulatory.
Grade 2 – 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) or / an MBChB degree and registration as a Medical Officer with the Health Professional Council of South Africa (HPCSA) at NQF level 8 as recognised by SAQA plus a minimum of six (6) years of clinical experience of which two (2) in regulatory.
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES: Knowledge and application of the Medicines and Related Substances Control Act 101of 1965, as amended, and its related Regulations, with respect to the regulation of medicines in terms of quality, safety, and efficacy. * Knowledge and understanding of the legal and regulatory framework governing the review process, locally and internationally. * An understanding of the medicine’s discovery process and the pharmaceutical regulatory environment. * Technical proficiency in regulatory review practices, pharmacokinetics, pharmacodynamics, bioavailability/bioequivalence, clinical study data analysis and review for safety, efficacy, and quality. * Computer literacy (MS Office packages). * Supervisory skills. * Good planning, organizational and interpersonal skills. * Good communication skills (written and verbal). * Innovative thinking, initiative, and leadership qualities. * Dedication and accurate work. * Knowledge of database management will be advantageous. * Must be willing to travel and work irregular hours. * A valid driver’s license. * Ability to work well under pressure. * Collaborative skills. * Knowledge of quality management systems. * Organisational awareness. * Good decision-making and critical analytical skills.
DUTIES: Assess, analyse, and provide recommendations for minor safety amendments (Type Iain and Type IB) applications, including the applicant’s responses to safety concerns raised by either the applicants or the Authority. Identify key issues, and critically evaluate scientific data (i.e., pharmacokinetic, bioavailability, and bioequivalence data, in vitro (pre-clinical) and in vivo clinical studies of a medicine with different endpoints) from multiple sources. Provide recommendations for major safety and/or efficacy amendments for simpler and complex molecules.
Conducting a comprehensive review to ensure that the risk profile of each medicinal product is regularly updated to incorporate new information and that risk criteria are modified based on new statistical data on hazards, possible damages to manage their impact on clinical practice and public health. Review and summarise relevant information from clinical trials for product information documents to ensure that the product information contains accurate claims on product effectiveness, and safety as well as adequate directions for product use. Consult other experts, act as a mentor, and provide guidance on assessments to other reviewers by conducting a critical review of their reports. Ensure timeous reviews of applications.
Identifies the parts of a scientific publication and the general purpose of each part. Searches published literature using key terms to find articles on specific subjects related to the application undergoing review. Summarises the essential message and purpose of published materials, such as scientific publications, reports, or guidelines. Utilises the full range of reference and resource materials in this area.
Generate detailed scientific evaluation reports in line with the good review practice guide, ICH guidelines, SAHPRA guidelines and other relevant international standards for internal peer review and where necessary, for presentation to the Advisory Clinical Committee. Prepare evaluation outcome (recommendations/queries/approval/non-approval) to be communicated to the external stakeholder.
Ensure priority medicines and urgent applications/responses are screened and identified as such for rapid processing as per the priority review policy. Attend to queries from previous and/or current screening cycle. Ensure that the outcome is captured on the database and that a rejection/approval letter is sent out to the applicant. Conduct thorough technical screening of variation applications for evaluation i.e., ensuring references submitted to support the proposed amendments are appropriate and complete.
Assess submissions for compliance with the local regulatory requirements as stipulated in the variation addendum and other clinical guidelines. Direct the implementation of different regulatory pathways based on reliance, collaboration, and recognition. Prepare a screening outcome report and to be communicated to the external stakeholders. Assess submissions for compliance with the Variation addendum and other clinical guidelines. Primary and peer review of responses with clinical data for simpler molecules.
Prepare a critical clinical response evaluation report after the review of the safety and/or efficacy data from clinical studies, published literature sources, reliance decisions of other regulatory authorities, or review of documented signals. Prepare evaluation outcome (recommendations/queries/approval/non-approval) and communicate outcome to the applicant.
Ensure an unqualified risk and internal audit opinion for Clinical Post-Registrations by submitting monthly POEs and updating the risk register monthly. Continuously respond to the needs and expectations of the industry, external evaluators, and Internal queries within a period of 1 week. Adherence to SOPs and SAHPRA, ICH, EMA and other relevant guidelines. Develop, review, and improve the accuracy of databases to enable revenue recognition by the finance unit. Respond to relevant queries timeously. Attend relevant training as may be necessary.
Liaising with management, legal and communications departments for advice to clarify established SAHPRA systems and methodologies. Provides comments, inputs and advice on international standards and guidance documents, representing the interest of SAHPRA at national, regional, and international levels. Provides regulatory support and guidance to industry and other stakeholders of the Authority. Provides support to management in the operation of the department/unit. Participate in special projects and Pre- and Post-registration working groups as required and engage in technical scientific discussions on ongoing applications under review.
Prepare discussion documents, including agendas, minutes and action items, and reports where required. Preparation of recommendations for pharmacovigilance referral outcome. Capturing and Execution of Advisory Clinical Committee recommendations. Participate in international scientific regulatory forums and discussion groups including ICH or WHO, as relevant and when nominated. Provide regular work-plans and output to the manager. Perform any other related duty as requested by the manager/senior manager.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names and email addresses of 3 referees and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
• Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: The closing date has been extended to the 12 January 2024 at 16H00. SAHPRA apologies for any inconvenience caused.
Re- Advertisement of Ref no:. SAHPRA 046-2023. Candidates who previously applied are encouraged to reapply.
MEDICINES REGISTRATION OFFICER
CLINICAL POST REGISTRATION X3
SALARY: R 657 376.00 – R834 199.00 per annum. (TOTAL COST TO COMPANY) (Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service.
Ref No.: SAHPRA 071/2023
CENTRE: Pretoria
Requirements: Matric certificate and appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) or / an MBChB degree and registration as a Medical Officer with the Health Professional Council of South Africa (HPCSA) at NQF level 8 as recognised by SAQA. A relevant Master’s qualification will be an added advantage.
Grade 1 – 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) or / an MBChB degree and registration as a Medical Officer with the Health Professional Council of South Africa (HPCSA) at NQF level 8 as recognised by SAQA plus a minimum of three (3) years of clinical experience of which one (1) in regulatory.
Grade 2 – 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) or / an MBChB degree and registration as a Medical Officer with the Health Professional Council of South Africa (HPCSA) at NQF level 8 as recognised by SAQA plus a minimum of six (6) years of clinical experience of which two (2) in regulatory.
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES: Knowledge and application of the Medicines and Related Substances Control Act 101of 1965, as amended, and its related Regulations, with respect to the regulation of medicines in terms of quality, safety, and efficacy. * Knowledge and understanding of the legal and regulatory framework governing the review process, locally and internationally. * An understanding of the medicine’s discovery process and the pharmaceutical regulatory environment. * Technical proficiency in regulatory review practices, pharmacokinetics, pharmacodynamics, bioavailability/bioequivalence, clinical study data analysis and review for safety, efficacy, and quality. * Computer literacy (MS Office packages). * Supervisory skills. * Good planning, organizational and interpersonal skills. * Good communication skills (written and verbal). * Innovative thinking, initiative, and leadership qualities. * Dedication and accurate work. * Knowledge of database management will be advantageous. * Must be willing to travel and work irregular hours. * A valid driver’s license. * Ability to work well under pressure. * Collaborative skills. * Knowledge of quality management systems. * Organisational awareness. * Good decision-making and critical analytical skills.
DUTIES: Assess, analyse, and provide recommendations for minor safety amendments (Type Iain and Type IB) applications, including the applicant’s responses to safety concerns raised by either the applicants or the Authority. Identify key issues, and critically evaluate scientific data (i.e., pharmacokinetic, bioavailability, and bioequivalence data, in vitro (pre-clinical) and in vivo clinical studies of a medicine with different endpoints) from multiple sources. Provide recommendations for major safety and/or efficacy amendments for simpler and complex molecules.
Conducting a comprehensive review to ensure that the risk profile of each medicinal product is regularly updated to incorporate new information and that risk criteria are modified based on new statistical data on hazards, possible damages to manage their impact on clinical practice and public health. Review and summarise relevant information from clinical trials for product information documents to ensure that the product information contains accurate claims on product effectiveness, and safety as well as adequate directions for product use. Consult other experts, act as a mentor, and provide guidance on assessments to other reviewers by conducting a critical review of their reports. Ensure timeous reviews of applications.
Identifies the parts of a scientific publication and the general purpose of each part. Searches published literature using key terms to find articles on specific subjects related to the application undergoing review. Summarises the essential message and purpose of published materials, such as scientific publications, reports, or guidelines. Utilises the full range of reference and resource materials in this area.
Generate detailed scientific evaluation reports in line with the good review practice guide, ICH guidelines, SAHPRA guidelines and other relevant international standards for internal peer review and where necessary, for presentation to the Advisory Clinical Committee. Prepare evaluation outcome (recommendations/queries/approval/non-approval) to be communicated to the external stakeholder.
Ensure priority medicines and urgent applications/responses are screened and identified as such for rapid processing as per the priority review policy. Attend to queries from previous and/or current screening cycle. Ensure that the outcome is captured on the database and that a rejection/approval letter is sent out to the applicant. Conduct thorough technical screening of variation applications for evaluation i.e., ensuring references submitted to support the proposed amendments are appropriate and complete.
Assess submissions for compliance with the local regulatory requirements as stipulated in the variation addendum and other clinical guidelines. Direct the implementation of different regulatory pathways based on reliance, collaboration, and recognition. Prepare a screening outcome report and to be communicated to the external stakeholders. Assess submissions for compliance with the Variation addendum and other clinical guidelines. Primary and peer review of responses with clinical data for simpler molecules.
Prepare a critical clinical response evaluation report after the review of the safety and/or efficacy data from clinical studies, published literature sources, reliance decisions of other regulatory authorities, or review of documented signals. Prepare evaluation outcome (recommendations/queries/approval/non-approval) and communicate outcome to the applicant.
Ensure an unqualified risk and internal audit opinion for Clinical Post-Registrations by submitting monthly POEs and updating the risk register monthly. Continuously respond to the needs and expectations of the industry, external evaluators, and Internal queries within a period of 1 week. Adherence to SOPs and SAHPRA, ICH, EMA and other relevant guidelines. Develop, review, and improve the accuracy of databases to enable revenue recognition by the finance unit. Respond to relevant queries timeously. Attend relevant training as may be necessary.
Liaising with management, legal and communications departments for advice to clarify established SAHPRA systems and methodologies. Provides comments, inputs and advice on international standards and guidance documents, representing the interest of SAHPRA at national, regional, and international levels. Provides regulatory support and guidance to industry and other stakeholders of the Authority. Provides support to management in the operation of the department/unit. Participate in special projects and Pre- and Post-registration working groups as required and engage in technical scientific discussions on ongoing applications under review.
Prepare discussion documents, including agendas, minutes and action items, and reports where required. Preparation of recommendations for pharmacovigilance referral outcome. Capturing and Execution of Advisory Clinical Committee recommendations. Participate in international scientific regulatory forums and discussion groups including ICH or WHO, as relevant and when nominated. Provide regular work-plans and output to the manager. Perform any other related duty as requested by the manager/senior manager.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names and email addresses of 3 referees and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
• Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: The closing date has been extended to the 12 January 2024 at 16H00. SAHPRA apologies for any inconvenience caused.
Re- Advertisement of Ref no:. SAHPRA 051-2023. Candidates who previously applied are encouraged to reapply.
INSPECTOR EVALUATOR (OFFICE BASED)
SALARY: R 657 376.00 – R834 199.00 per annum. (TOTAL COST TO COMPANY)
(Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service.
Ref No.: SAHPRA 064/2023
CENTRE: Pretoria
REQUIREMENTS: Matric certificate and appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) or / Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA. A relevant Master’s qualification will be an added advantage.
Grade 1 – 4-year Bachelor of Pharmacy Degree NQF or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of five (5) of experience in pharmaceutical industry post community service, preferably in good manufacturing practices. Extensive knowledge of GDPs regulations and industry practice, as well as substantial experience of undertaking GxP inspections within a regulatory environment.
Grade 2 – 4-year Bachelor of Pharmacy Degree NQF or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of three (3) of experience in pharmaceutical industry post community service, preferably in good manufacturing practices. Extensive knowledge of GDPs regulations and industry practice, as well as substantial experience of undertaking GxP inspections within a regulatory environment or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of ten (10) years of experience in pharmaceutical regulatory or GMP environment. Extensive knowledge of GDPs regulations and industry practice, as well as substantial experience of undertaking GxP inspections within a regulatory environment
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES: Comprehensive and sound knowledge of all relevant legislation, protocols, regulations, and guidelines pertaining to the Medicines and Related Substances Act 101 of 1965. * Good verbal and numerical reasoning skills to allow analysis and interpretation of written and numerical data. * Good communication skills (verbal, written, conflict management and resolution). * Delivery of service objectives with professional excellence and efficiency. * Ability to make effective decisions by using evidence and knowledge to support accurate, expert decisions and advice while carefully considering the implications of such a decision. * Ability to work unsupervised for long periods of time. * Ability to work within a team environment. * Good planning and organisational skills. * Ability to meet tight deadlines and manage multiple, often competing priorities. * Knowledge of MS Office. * Valid Driver’s License. * Ethical behaviour and adherence to the SAHPRA Code of Conduct.
DUTIES: To evaluate applications from HCRs and manufactures for the introduction of new medicine in line with the Medicine and Related Substances Act, No. 101 of 1965. • To perform evaluations of once- off deviations by HCR or manufacturers • To evaluate type 1 and type 2 variations as per guidance SAHPS-INSP-GMP-13• To perform desktop reviews/ assessments for manufacturing and testing facilities, thus reducing duplication and frequency of inspections. • To assess and evaluate the applications for Post Importation Testing exemptions. • To evaluate and issue GMP and CPP certificates applications. • Evaluate Standard Operating Procedures (SOPs) of Inspectorate for compliance with GMP Guidelines as adopted by SAHPRA.• To work closely across inspection teams, SAHPRA departments and external regulators to ensure evaluation activities are planned and communicated effectively.• To support inspectors by providing relevant and timely information related to any inspections that are to be carried out.• To contribute to the Inspectorate’s compliance management process by ensuring that instances of suspected or known non-compliance are handled in the appropriate manner.• Liaise with inspectors across internal departments.• Assist in minuting the recommendations of relevant advisory committees of SAHPRA applicable to the activities of the inspectorate.• Record statistics of generated and peer-reviewed reports• Attend on-the-job training and apply continuous professional development principles to ensure knowledge remains relevant and current in line with any regulatory requirements.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names and email addresses of 3 referees and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
• Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: The closing date has been extended to the 12 January 2024 at 16H00. SAHPRA apologies for any inconvenience caused.
Re- Advertisement of Ref no:. SAHPRA 051-2023. Candidates who previously applied are encouraged to reapply.
INSPECTOR EVALUATOR (OFFICE BASED)
SALARY: R 657 376.00 – R834 199.00 per annum. (TOTAL COST TO COMPANY)
(Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service.
Ref No.: SAHPRA 064/2023
CENTRE: Pretoria
REQUIREMENTS: Matric certificate and appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) or / Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA. A relevant Master’s qualification will be an added advantage.
Grade 1 – 4-year Bachelor of Pharmacy Degree NQF or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of five (5) of experience in pharmaceutical industry post community service, preferably in good manufacturing practices. Extensive knowledge of GDPs regulations and industry practice, as well as substantial experience of undertaking GxP inspections within a regulatory environment.
Grade 2 – 4-year Bachelor of Pharmacy Degree NQF or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of three (3) of experience in pharmaceutical industry post community service, preferably in good manufacturing practices. Extensive knowledge of GDPs regulations and industry practice, as well as substantial experience of undertaking GxP inspections within a regulatory environment or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of ten (10) years of experience in pharmaceutical regulatory or GMP environment. Extensive knowledge of GDPs regulations and industry practice, as well as substantial experience of undertaking GxP inspections within a regulatory environment
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES: Comprehensive and sound knowledge of all relevant legislation, protocols, regulations, and guidelines pertaining to the Medicines and Related Substances Act 101 of 1965. * Good verbal and numerical reasoning skills to allow analysis and interpretation of written and numerical data. * Good communication skills (verbal, written, conflict management and resolution). * Delivery of service objectives with professional excellence and efficiency. * Ability to make effective decisions by using evidence and knowledge to support accurate, expert decisions and advice while carefully considering the implications of such a decision. * Ability to work unsupervised for long periods of time. * Ability to work within a team environment. * Good planning and organisational skills. * Ability to meet tight deadlines and manage multiple, often competing priorities. * Knowledge of MS Office. * Valid Driver’s License. * Ethical behaviour and adherence to the SAHPRA Code of Conduct.
DUTIES: To evaluate applications from HCRs and manufactures for the introduction of new medicine in line with the Medicine and Related Substances Act, No. 101 of 1965. • To perform evaluations of once- off deviations by HCR or manufacturers • To evaluate type 1 and type 2 variations as per guidance SAHPS-INSP-GMP-13• To perform desktop reviews/ assessments for manufacturing and testing facilities, thus reducing duplication and frequency of inspections. • To assess and evaluate the applications for Post Importation Testing exemptions. • To evaluate and issue GMP and CPP certificates applications. • Evaluate Standard Operating Procedures (SOPs) of Inspectorate for compliance with GMP Guidelines as adopted by SAHPRA.• To work closely across inspection teams, SAHPRA departments and external regulators to ensure evaluation activities are planned and communicated effectively.• To support inspectors by providing relevant and timely information related to any inspections that are to be carried out.• To contribute to the Inspectorate’s compliance management process by ensuring that instances of suspected or known non-compliance are handled in the appropriate manner.• Liaise with inspectors across internal departments.• Assist in minuting the recommendations of relevant advisory committees of SAHPRA applicable to the activities of the inspectorate.• Record statistics of generated and peer-reviewed reports• Attend on-the-job training and apply continuous professional development principles to ensure knowledge remains relevant and current in line with any regulatory requirements.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names and email addresses of 3 referees and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
• Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: The closing date has been extended to the 12 January 2024 at 16H00. SAHPRA apologies for any inconvenience caused.
Re- Advertisement of Ref no:. SAHPRA 039-2023. Candidates who previously applied are encouraged to reapply.
TECHNICAL OFFICER: MEDICAL DEVICES REGISTRATION
SALARY: R 657 376.00 – R834 199.00 per annum. (TOTAL COST TO COMPANY)
(Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service.
Ref No.: SAHPRA 077/2023
CENTRE: Pretoria
Requirements: Matric certificate and appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) or / Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA. A relevant Master’s qualification will be an added advantage.
Grade 1 – 4-year Bachelor of Pharmacy Degree NQF or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of five (5) of experience in pharmaceutical regulatory environment. Training in (i) regulation and/or registration of medical devices and (ii) assessment of quality, safety, performance of medical devices.
Grade 2 - 4-year Bachelor of Pharmacy Degree NQF level 8 as recognised by SAQA and registration as a Pharmacist with South African Pharmacy Council (SAPC) and minimum of three (3) years of experience in pharmaceutical regulatory environment. Training in (i) regulation and/or registration of medical devices and (ii) assessment of quality, safety, performance of medical devices or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of ten (10) years of experience in pharmaceutical regulatory environment. Training in (i) regulation and/or registration of medical devices and (ii) assessment of quality, safety, performance of medical devices.
COMPETENCIES (KNOWLEDGE, SKILLS AND ABILITIES): * Comprehensive knowledge and understanding of relevant legislation, standard operating procedures and work instructions. * Preparation of financial reports. * Performance measurement skills. * Self-motivated and able to work independently. * Ability to work with a variety of cross-functional team members. * Competent in problem solving. * Information evaluation. * Decision making. * Objectivity. * Resilience. * Communication skills (verbal, written, negotiation, conflict management, presentation). * Interpersonal skills. * Assertiveness. * Ethical behaviour. * Customer service. * Planning and organising skills.
DUTIES: Develop and maintain guidelines and standard operating procedures for medical device and IVD clinical trials. (Quality Management: * Internal review, draft, creation of new Guidelines and publications. * Review and drafting of SOPS related to technical review. * Call up notices for 1st phase drafted and review. * Phase drafted and review. *Review of MOU). Technical screening of new clinical trial applications and allocation of clinical trials to the evaluators. Finalisation of medical device clinical trials within 60 days (including RUO) Review protocol amendments and additional investigators and site. Attend to queries addressed concerning Clinical Trials Unit. Evaluate and manage applications for clinical trials of medical devices and IVDs and maintain relevant databases. To evaluate applications for clinical trials for medical devices being conducted in South Africa or Outside South Africa, if necessary. Support the work of committee (CEC and MDC): Prepare reports for SAHPRA and relevant advisory committees. Liaise with international regulatory authorities. Assist in minuting the recommendations of relevant advisory committees of SAHPRA applicable to the activities of the unit (Recommendations sent to application in a timely manner). Interview members from industry to discuss SAHPRA Board resolutions, requirements of the Act and medical device and IVD clinical trial issues. Investigate and attend to industry / applicant’s queries. Perform other relevant functions that may arise from time to time. Capture and maintain data relating to measuring and monitoring performance metrics and peer reviewed reports, and record statistics generated, including the units quarterly report and monthly financial reports. Manage the associated risks and audit queries, and correspondence from applicants and stakeholders. Submit weekly work-plan and output to the Unit manager (quantitative and qualitative reports). Internal Audit: * No. of audit findings per internal audit per quarter (Technical Related). * Monthly Finance reporting.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names and email addresses of 3 referees and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
• Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: The closing date has been extended to the 12 January 2024 at 16H00. SAHPRA apologies for any inconvenience caused.
Re- Advertisement of Ref no:. SAHPRA 039-2023. Candidates who previously applied are encouraged to reapply.
TECHNICAL OFFICER: MEDICAL DEVICES REGISTRATION
SALARY: R 657 376.00 – R834 199.00 per annum. (TOTAL COST TO COMPANY)
(Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service.
Ref No.: SAHPRA 077/2023
CENTRE: Pretoria
Requirements: Matric certificate and appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) or / Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA. A relevant Master’s qualification will be an added advantage.
Grade 1 – 4-year Bachelor of Pharmacy Degree NQF or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of five (5) of experience in pharmaceutical regulatory environment. Training in (i) regulation and/or registration of medical devices and (ii) assessment of quality, safety, performance of medical devices.
Grade 2 - 4-year Bachelor of Pharmacy Degree NQF level 8 as recognised by SAQA and registration as a Pharmacist with South African Pharmacy Council (SAPC) and minimum of three (3) years of experience in pharmaceutical regulatory environment. Training in (i) regulation and/or registration of medical devices and (ii) assessment of quality, safety, performance of medical devices or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of ten (10) years of experience in pharmaceutical regulatory environment. Training in (i) regulation and/or registration of medical devices and (ii) assessment of quality, safety, performance of medical devices.
COMPETENCIES (KNOWLEDGE, SKILLS AND ABILITIES): * Comprehensive knowledge and understanding of relevant legislation, standard operating procedures and work instructions. * Preparation of financial reports. * Performance measurement skills. * Self-motivated and able to work independently. * Ability to work with a variety of cross-functional team members. * Competent in problem solving. * Information evaluation. * Decision making. * Objectivity. * Resilience. * Communication skills (verbal, written, negotiation, conflict management, presentation). * Interpersonal skills. * Assertiveness. * Ethical behaviour. * Customer service. * Planning and organising skills.
DUTIES: Develop and maintain guidelines and standard operating procedures for medical device and IVD clinical trials. (Quality Management: * Internal review, draft, creation of new Guidelines and publications. * Review and drafting of SOPS related to technical review. * Call up notices for 1st phase drafted and review. * Phase drafted and review. *Review of MOU). Technical screening of new clinical trial applications and allocation of clinical trials to the evaluators. Finalisation of medical device clinical trials within 60 days (including RUO) Review protocol amendments and additional investigators and site. Attend to queries addressed concerning Clinical Trials Unit. Evaluate and manage applications for clinical trials of medical devices and IVDs and maintain relevant databases. To evaluate applications for clinical trials for medical devices being conducted in South Africa or Outside South Africa, if necessary. Support the work of committee (CEC and MDC): Prepare reports for SAHPRA and relevant advisory committees. Liaise with international regulatory authorities. Assist in minuting the recommendations of relevant advisory committees of SAHPRA applicable to the activities of the unit (Recommendations sent to application in a timely manner). Interview members from industry to discuss SAHPRA Board resolutions, requirements of the Act and medical device and IVD clinical trial issues. Investigate and attend to industry / applicant’s queries. Perform other relevant functions that may arise from time to time. Capture and maintain data relating to measuring and monitoring performance metrics and peer reviewed reports, and record statistics generated, including the units quarterly report and monthly financial reports. Manage the associated risks and audit queries, and correspondence from applicants and stakeholders. Submit weekly work-plan and output to the Unit manager (quantitative and qualitative reports). Internal Audit: * No. of audit findings per internal audit per quarter (Technical Related). * Monthly Finance reporting.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names and email addresses of 3 referees and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
• Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: The closing date has been extended to the 12 January 2024 at 16H00. SAHPRA apologies for any inconvenience caused.
Re- Advertisement of Ref no:. SAHPRA 036-2023. Candidates who previously applied are encouraged to reapply.
MEDICINE REGISTRATION OFFICER:
HEALTH PRODUCTS AUTHORISATION: RENEWALS X6
SALARY: R 657 376.00 – R834 199.00 per annum. (TOTAL COST TO COMPANY)
(Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service.
Ref No.: SAHPRA 063/2023
CENTRE: Pretoria
REQUIREMENTS: • Matric certificate and appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) or / Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA.
Grade 1 – 4-year Bachelor of Pharmacy Degree NQF or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of five (5) of experience in regulatory. Knowledge of technical evaluation of quality, safety and efficacy aspects of medicines.
Grade 2 - 4-year Bachelor of Pharmacy Degree NQF level 8 as recognised by SAQA and registration as a Pharmacist with South African Pharmacy Council (SAPC) and minimum of three (3) years’ experience in regulatory or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of ten (10) years of experience in regulatory). Knowledge of technical evaluation of quality, safety and efficacy aspects of medicines.
COMPETENCIES, KNOWLEDGE AND SKILLS: * Knowledge and application of the Medicines and Related Substances Control Act (101 of 1965), as amended, and its related Regulations, with respect to the regulation of medicines in terms of quality, safety, and efficacy. * Knowledge of requirements for medicine Product Quality Reviews, the associated technical aspects of manufacturing and relevant Good Manufacturing Practices, as per SAHPRA GMP. * Knowledge of technical aspects for evaluation of quality and efficacy of bioequivalence of medicines. * Comprehensive knowledge and understanding of relevant legislation, guidelines, protocols, standard operating procedures, and work instructions as outlined by regulatory authorities. * Good planning, organizational and interpersonal skills. * Self-motivated and able to work independently. * Decision making informed by technical expertise. * Good communication skills (written, verbal, negotiation, conflict management, presentation). * Innovative thinking, initiative, assertive and leadership qualities. * Dedication and accurate work. * Ability to manage a variety of cross-functional team members. * Ethical behaviour. * Computer skills (knowledge of MS Office). * Must be willing to travel and work irregular hours. * Customer service. *A valid driver’s licence.
DUTIES: • Evaluation and peer-reviewing of renewal applications: * Evaluate and generate evaluation report(s) for renewal applications (Generics) in compliance with required template and adopted regulatory and scientific standards as per GMP PIC/s guidelines, EMA renewal guidelines etc and submit for peer review. * Peer review evaluation reports, in compliance with good review practice and draft peer reviewed report. * Request QA, expert advice or send to technical committee meeting if necessary and submit signed report for filing and further processing. * Following peer review process, amend the report (s) accordingly to generate a list of queries to the applicant using the correct templates. * Prepare reports or memos for the internal working groups. * Prepare query letter to the applicant. * Prepare a basis of approval or rejection. * Provide quality assurance of reports and facilitate resolutions on technical matters.
• Evaluate applicant responses of renewal applications: * Evaluate and generate second (and subsequent) evaluation report (s) for each response application and submit for peer review in compliance with required template and adopted regulatory /scientific standards and submit for peer review. * Peer review other evaluators response reports, according to the required template and adopted regulatory/scientific standards. * Prepare report and record outcomes for the internal working groups, technical meetings or committee meeting. * Prepare query letter to the applicant. * Prepare a basis of approval or rejection.* Provide quality assurance of reports and facilitate resolutions on technical matters.
• Technical screening of renewal applications: * Generate technical screening evaluation report(s) for each application and submit for peer review. * Following peer review process, amend the technical screening report (s) accordingly to generate a list of queries to the applicant using the correct templates. * Peer-review technical screening report (s) done by other reviewers.* Prepare screening query / screening rejection letter to the applicant. * Provide quality assurance of reports and facilitate resolutions on technical matters.
• Develop and update guidelines, SOPs, and templates: * Review existing guidelines, SOPs and templates and update when necessary. * Provide training on guidelines, SOPs, and templates. * Create new guidelines, SOPs, and templates where SOPs are not in place. * Provide regular work-plans and output to the unit manager (qualitative and quantitative report). * Perform any other related duty as requested by manager/senior manager.
• Participate in technical working groups or special projects and provide support to the unit as well as to the Advisory Committees: * Participate in special projects as necessary based on technical and operational needs of the unit. * Lead and manage assessments peer review and discussion working group where relevant. * Compile discussion documents and reports. * Take comprehensive notes of discussions of relevant discussions.
• Risk Management and Audit: * SOPs and guidelines must be adhered to. * Create and maintain data bases. * Use the most current templates and guidelines. * Provide and attend relevant training as may be necessary. * Align with QMS requirements. * Align with ICH/VICH, WHO and international standards and use the most current SAHPRA templates and guidelines.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names and email addresses of 3 referees and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
• Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: The closing date has been extended to the 12 January 2024 at 16H00. SAHPRA apologies for any inconvenience caused.
Re- Advertisement of Ref no:. SAHPRA 036-2023. Candidates who previously applied are encouraged to reapply.
MEDICINE REGISTRATION OFFICER:
HEALTH PRODUCTS AUTHORISATION: RENEWALS X6
SALARY: R 657 376.00 – R834 199.00 per annum. (TOTAL COST TO COMPANY)
(Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service.
Ref No.: SAHPRA 063/2023
CENTRE: Pretoria
REQUIREMENTS: • Matric certificate and appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) or / Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA.
Grade 1 – 4-year Bachelor of Pharmacy Degree NQF or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of five (5) of experience in regulatory. Knowledge of technical evaluation of quality, safety and efficacy aspects of medicines.
Grade 2 - 4-year Bachelor of Pharmacy Degree NQF level 8 as recognised by SAQA and registration as a Pharmacist with South African Pharmacy Council (SAPC) and minimum of three (3) years’ experience in regulatory or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of ten (10) years of experience in regulatory). Knowledge of technical evaluation of quality, safety and efficacy aspects of medicines.
COMPETENCIES, KNOWLEDGE AND SKILLS: * Knowledge and application of the Medicines and Related Substances Control Act (101 of 1965), as amended, and its related Regulations, with respect to the regulation of medicines in terms of quality, safety, and efficacy. * Knowledge of requirements for medicine Product Quality Reviews, the associated technical aspects of manufacturing and relevant Good Manufacturing Practices, as per SAHPRA GMP. * Knowledge of technical aspects for evaluation of quality and efficacy of bioequivalence of medicines. * Comprehensive knowledge and understanding of relevant legislation, guidelines, protocols, standard operating procedures, and work instructions as outlined by regulatory authorities. * Good planning, organizational and interpersonal skills. * Self-motivated and able to work independently. * Decision making informed by technical expertise. * Good communication skills (written, verbal, negotiation, conflict management, presentation). * Innovative thinking, initiative, assertive and leadership qualities. * Dedication and accurate work. * Ability to manage a variety of cross-functional team members. * Ethical behaviour. * Computer skills (knowledge of MS Office). * Must be willing to travel and work irregular hours. * Customer service. *A valid driver’s licence.
DUTIES: • Evaluation and peer-reviewing of renewal applications: * Evaluate and generate evaluation report(s) for renewal applications (Generics) in compliance with required template and adopted regulatory and scientific standards as per GMP PIC/s guidelines, EMA renewal guidelines etc and submit for peer review. * Peer review evaluation reports, in compliance with good review practice and draft peer reviewed report. * Request QA, expert advice or send to technical committee meeting if necessary and submit signed report for filing and further processing. * Following peer review process, amend the report (s) accordingly to generate a list of queries to the applicant using the correct templates. * Prepare reports or memos for the internal working groups. * Prepare query letter to the applicant. * Prepare a basis of approval or rejection. * Provide quality assurance of reports and facilitate resolutions on technical matters.
• Evaluate applicant responses of renewal applications: * Evaluate and generate second (and subsequent) evaluation report (s) for each response application and submit for peer review in compliance with required template and adopted regulatory /scientific standards and submit for peer review. * Peer review other evaluators response reports, according to the required template and adopted regulatory/scientific standards. * Prepare report and record outcomes for the internal working groups, technical meetings or committee meeting. * Prepare query letter to the applicant. * Prepare a basis of approval or rejection.* Provide quality assurance of reports and facilitate resolutions on technical matters.
• Technical screening of renewal applications: * Generate technical screening evaluation report(s) for each application and submit for peer review. * Following peer review process, amend the technical screening report (s) accordingly to generate a list of queries to the applicant using the correct templates. * Peer-review technical screening report (s) done by other reviewers.* Prepare screening query / screening rejection letter to the applicant. * Provide quality assurance of reports and facilitate resolutions on technical matters.
• Develop and update guidelines, SOPs, and templates: * Review existing guidelines, SOPs and templates and update when necessary. * Provide training on guidelines, SOPs, and templates. * Create new guidelines, SOPs, and templates where SOPs are not in place. * Provide regular work-plans and output to the unit manager (qualitative and quantitative report). * Perform any other related duty as requested by manager/senior manager.
• Participate in technical working groups or special projects and provide support to the unit as well as to the Advisory Committees: * Participate in special projects as necessary based on technical and operational needs of the unit. * Lead and manage assessments peer review and discussion working group where relevant. * Compile discussion documents and reports. * Take comprehensive notes of discussions of relevant discussions.
• Risk Management and Audit: * SOPs and guidelines must be adhered to. * Create and maintain data bases. * Use the most current templates and guidelines. * Provide and attend relevant training as may be necessary. * Align with QMS requirements. * Align with ICH/VICH, WHO and international standards and use the most current SAHPRA templates and guidelines.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names and email addresses of 3 referees and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
• Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: The closing date has been extended to the 12 January 2024 at 16H00. SAHPRA apologies for any inconvenience caused.
GOOD MANUFACTURING PRACTICE (GMP) INSPECTOR X 5
SALARY: R 657 376.00 – R834 199.00 per annum. (TOTAL COST TO COMPANY)
FIXED-TERM CONTRACT (ENDS IN MARCH 2025)
(Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service.
Ref No.: SAHPRA 067/2023
CENTRE: Pretoria
REQUIREMENTS: Matric certificate and appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) or / Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA. A relevant Master’s qualification will be an added advantage.
Grade 1 – 4-year Bachelor of Pharmacy Degree NQF or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of five (5) of experience in pharmaceutical regulatory or GMP environment. Extensive knowledge of GMP regulations and industry practice, as well as substantial experience of undertaking GMP inspections within a regulatory environment.
Grade 2 - 4-year Bachelor of Pharmacy Degree NQF level 8 as recognised by SAQA and registration as a Pharmacist with South African Pharmacy Council (SAPC) and minimum of three (3) years of experience in pharmaceutical regulatory or GMP environment. Extensive knowledge of GMP regulations and industry practice, as well as substantial experience of undertaking GMP inspections within a regulatory environment or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of ten (10) years of experience in pharmaceutical regulatory or GMP environment. Extensive knowledge of GMP regulations and industry practice, as well as substantial experience of undertaking GMP inspections within a regulatory environment.
CORE COMPETENCIES, TECHNICAL PROFICIENCIES, AND VALUES: *Comprehensive and sound knowledge of all relevant legislation, protocols, regulations, and guidelines pertaining to the Medicines and Related Substances Act 101 of 1965. *Good verbal and numerical reasoning skills to allow analysis and interpretation of written and numerical data. *Good communication skills (verbal, written, conflict management and resolution). *Resilience. *Delivery of service objectives with professional excellence and efficiency. *Ability to make effective decisions by using evidence and knowledge to support accurate, expert decisions and advice while carefully considering the implications of such a decision. *Ability to work unsupervised for long periods of time. *Ability to work within a team environment. *Good planning and organisational skills. *Ability to meet tight deadlines and manage multiple, often competing priorities. *Knowledge of MS Office. *Valid Driver’s License. *Ethical behaviour and adherence to the SAHPRA Code of Conduct. *At SAHPRA we adhere to our core values: *Ubuntu *Responsiveness *Integrity *Transparency *Efficiency *Excellence
DUTIES: Inspect pharmaceutical manufacturing sites for compliance with Good Manufacturing Practices as accepted by SAHPRA. Assess and evaluate GMP inspection reports of other regulatory authorities on international pharmaceutical manufacturing sites where medicines for exportation to South Africa are manufactured. Perform Pre- and Post-Registration inspections on information submitted in a medicine application dossier. Perform Once-Off evaluation on information submitted by HCR (Applicants). To work closely across inspection teams, SAHPRA departments and external regulators to ensure inspection activities are planned and communicated effectively. Evaluate Standard Operating Procedures (SOPs) of Inspectorate for compliance with GMP/GWP Guidelines as adopted by SAHPRA. To contribute to the Inspectorate’s compliance management process by ensuring that instances of suspected or known non-compliance are handled in the appropriate manner. Prepare reports for SAHPRA and relevant advisory committees and the Finance department. Liaise with inspectors from international regulatory authorities. Assist in minuting the recommendations of relevant advisory committees of SAHPRA applicable to the activities of the inspectorate. Interview members from the industry to discuss SAHPRA Board resolutions and requirements of the Medicine and Related Substances Act, No. 101 of 1965 [and medicines quality issues. To provide advisory support to key stakeholders, including participation in Regulatory meetings and conferences, external presentations all while demonstrating sound industry and technical knowledge. Record statistics of generated and peer-reviewed reports. Manage the associated risks and audit queries through a clear governance process, ensuring that the correct procedure is followed, care taken, and ethical behaviour demonstrated when managing inspection-related resources and that all relevant records and evidence is sufficiently maintained for audit purposes.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names and email addresses of 3 referees and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
• Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: The closing date has been extended to the 12 January 2024 at 16H00. SAHPRA apologies for any inconvenience caused.
GOOD MANUFACTURING PRACTICE (GMP) INSPECTOR X 5
SALARY: R 657 376.00 – R834 199.00 per annum. (TOTAL COST TO COMPANY)
FIXED-TERM CONTRACT (ENDS IN MARCH 2025)
(Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service.
Ref No.: SAHPRA 067/2023
CENTRE: Pretoria
REQUIREMENTS: Matric certificate and appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) or / Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA. A relevant Master’s qualification will be an added advantage.
Grade 1 – 4-year Bachelor of Pharmacy Degree NQF or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of five (5) of experience in pharmaceutical regulatory or GMP environment. Extensive knowledge of GMP regulations and industry practice, as well as substantial experience of undertaking GMP inspections within a regulatory environment.
Grade 2 - 4-year Bachelor of Pharmacy Degree NQF level 8 as recognised by SAQA and registration as a Pharmacist with South African Pharmacy Council (SAPC) and minimum of three (3) years of experience in pharmaceutical regulatory or GMP environment. Extensive knowledge of GMP regulations and industry practice, as well as substantial experience of undertaking GMP inspections within a regulatory environment or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of ten (10) years of experience in pharmaceutical regulatory or GMP environment. Extensive knowledge of GMP regulations and industry practice, as well as substantial experience of undertaking GMP inspections within a regulatory environment.
CORE COMPETENCIES, TECHNICAL PROFICIENCIES, AND VALUES: *Comprehensive and sound knowledge of all relevant legislation, protocols, regulations, and guidelines pertaining to the Medicines and Related Substances Act 101 of 1965. *Good verbal and numerical reasoning skills to allow analysis and interpretation of written and numerical data. *Good communication skills (verbal, written, conflict management and resolution). *Resilience. *Delivery of service objectives with professional excellence and efficiency. *Ability to make effective decisions by using evidence and knowledge to support accurate, expert decisions and advice while carefully considering the implications of such a decision. *Ability to work unsupervised for long periods of time. *Ability to work within a team environment. *Good planning and organisational skills. *Ability to meet tight deadlines and manage multiple, often competing priorities. *Knowledge of MS Office. *Valid Driver’s License. *Ethical behaviour and adherence to the SAHPRA Code of Conduct. *At SAHPRA we adhere to our core values: *Ubuntu *Responsiveness *Integrity *Transparency *Efficiency *Excellence
DUTIES: Inspect pharmaceutical manufacturing sites for compliance with Good Manufacturing Practices as accepted by SAHPRA. Assess and evaluate GMP inspection reports of other regulatory authorities on international pharmaceutical manufacturing sites where medicines for exportation to South Africa are manufactured. Perform Pre- and Post-Registration inspections on information submitted in a medicine application dossier. Perform Once-Off evaluation on information submitted by HCR (Applicants). To work closely across inspection teams, SAHPRA departments and external regulators to ensure inspection activities are planned and communicated effectively. Evaluate Standard Operating Procedures (SOPs) of Inspectorate for compliance with GMP/GWP Guidelines as adopted by SAHPRA. To contribute to the Inspectorate’s compliance management process by ensuring that instances of suspected or known non-compliance are handled in the appropriate manner. Prepare reports for SAHPRA and relevant advisory committees and the Finance department. Liaise with inspectors from international regulatory authorities. Assist in minuting the recommendations of relevant advisory committees of SAHPRA applicable to the activities of the inspectorate. Interview members from the industry to discuss SAHPRA Board resolutions and requirements of the Medicine and Related Substances Act, No. 101 of 1965 [and medicines quality issues. To provide advisory support to key stakeholders, including participation in Regulatory meetings and conferences, external presentations all while demonstrating sound industry and technical knowledge. Record statistics of generated and peer-reviewed reports. Manage the associated risks and audit queries through a clear governance process, ensuring that the correct procedure is followed, care taken, and ethical behaviour demonstrated when managing inspection-related resources and that all relevant records and evidence is sufficiently maintained for audit purposes.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names and email addresses of 3 referees and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
• Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: The closing date has been extended to the 12 January 2024 at 16H00. SAHPRA apologies for any inconvenience caused.
Re- Advertisement of Ref no:. SAHPRA 050-2023. Candidates who previously applied are encouraged to reapply.
MEDICINES REGISTRATION OFFICER:
PHARMACEUTICAL EVALUATION MANAGEMENT: PRE-REGISTRATION X5
SALARY: R 657 376.00 – R834 199.00 per annum. (TOTAL COST TO COMPANY)
(Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service.
Ref No.: SAHPRA 076/2023
CENTRE: Pretoria
Requirements: Matric certificate and appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) or / Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA. A relevant Master’s qualification will be an added advantage.
Grade 1 – 4-year Bachelor of Pharmacy Degree NQF or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of five (5) of experience in pharmaceutical regulatory environment or related medicine production quality assurance sector.
Grade 2 - 4-year Bachelor of Pharmacy Degree NQF level 8 as recognised by SAQA and registration as a Pharmacist with South African Pharmacy Council (SAPC) and minimum of three (3) years of experience in pharmaceutical regulatory environment or related medicine production quality assurance sector or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of ten (10) years of experience in pharmaceutical regulatory environment or related medicine production quality assurance sector
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES: CORE COMPETENCIES AND TECHNICAL PROFICIENCIES: Knowledge and application of the Medicines and Related Substances Act (101 of 1965) as amended and its related Regulations and Guidelines. * Knowledge of technical aspects for evaluation of quality and efficacy (bioequivalence) of medicines. * Computer literacy and sound working knowledge of computer software packages. * Technical and scientific aspects of medicine regulation. * Evaluation guidelines as prescribed by the relevant regulatory authorities. * Planning and organisational skills. * Leadership skills. * Coordination skills. * Written and verbal communication skills. * Diversity management. * Time management. * Good telephone etiquette. * Supervisory skills.
DUTIES: Generate evaluation report(s) for each new applications (NCE and Generics) in compliance with required template and adopted regulatory /scientific standards and submit for peer review. * Following peer review process amend the report (s) accordingly to generate a list of queries to the applicant using the correct templates. * Peer-review primary report (s) done by other reviewers. * Prepare report for the internal working groups and where necessary present at advisory committee for complex scientific matters. * Prepare query letter to the applicant. * Prepare a basis of approval or rejection. * Provide quality assurance of reports and facilitate resolutions on technical matters.
Generate second (and subsequent) evaluation report (s) for each response application and submit for peer review in compliance with required template and adopted regulatory /scientific standards and submit for peer review. * Following peer review process amend the report accordingly to generate a list of queries to the applicant, if necessary; * Peer review other evaluators response reports, according to the required template and adopted regulatory/scientific standards. * Prepare report for the internal working groups and where necessary present at advisory committee for complex scientific matters. * Prepare query letter to the applicant. * Prepare a basis of approval or rejection. Provide quality assurance of reports and facilitate resolutions on technical matters.
Generate technical screening evaluation report(s) for each application and submit for peer review. * Following peer review process amend the technical screening report (s) accordingly to generate a list of queries to the applicant using the correct templates. * Peer-review technical screening report (s) done by other reviewers. * Prepare screening query / screening rejection letter to the applicant. * Provide quality assurance of reports and facilitate resolutions on technical matters.
Review existing guidelines, SOPs and templates and update when necessary. * Provide training on guidelines, SOPs and templates. * Create new guidelines, SOPs and templates where relevant. * Provide regular work-plans and output to the unit manager (qualitative and quantities report). * Perform any other related duty as requested by manager/senior manager.
Participate in special projects and registration group. * Lead and manage assessments peer review and discussion working group where relevant. * Compile discussion documents and reports. * Provide regular trainings to new internal MRO’s and external evaluators. * Take comprehensive notes of discussions of relevant discussions. * Prepare documents for SAHPRA management/ RC meeting.
SOP’s and Guidelines must be adhered to. * Create and maintain data bases. * Use the most current templates and guidelines. * Provide and attend relevant training as may be necessary. * Align with QMS requirements. Align with ICH, WHO, IPRP and international standards.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names and email addresses of 3 referees and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
• Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: The closing date has been extended to the 12 January 2024 at 16H00. SAHPRA apologies for any inconvenience caused.
Re- Advertisement of Ref no:. SAHPRA 050-2023. Candidates who previously applied are encouraged to reapply.
MEDICINES REGISTRATION OFFICER:
PHARMACEUTICAL EVALUATION MANAGEMENT: PRE-REGISTRATION X5
SALARY: R 657 376.00 – R834 199.00 per annum. (TOTAL COST TO COMPANY)
(Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service.
Ref No.: SAHPRA 076/2023
CENTRE: Pretoria
Requirements: Matric certificate and appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) or / Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA. A relevant Master’s qualification will be an added advantage.
Grade 1 – 4-year Bachelor of Pharmacy Degree NQF or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of five (5) of experience in pharmaceutical regulatory environment or related medicine production quality assurance sector.
Grade 2 - 4-year Bachelor of Pharmacy Degree NQF level 8 as recognised by SAQA and registration as a Pharmacist with South African Pharmacy Council (SAPC) and minimum of three (3) years of experience in pharmaceutical regulatory environment or related medicine production quality assurance sector or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of ten (10) years of experience in pharmaceutical regulatory environment or related medicine production quality assurance sector
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES: CORE COMPETENCIES AND TECHNICAL PROFICIENCIES: Knowledge and application of the Medicines and Related Substances Act (101 of 1965) as amended and its related Regulations and Guidelines. * Knowledge of technical aspects for evaluation of quality and efficacy (bioequivalence) of medicines. * Computer literacy and sound working knowledge of computer software packages. * Technical and scientific aspects of medicine regulation. * Evaluation guidelines as prescribed by the relevant regulatory authorities. * Planning and organisational skills. * Leadership skills. * Coordination skills. * Written and verbal communication skills. * Diversity management. * Time management. * Good telephone etiquette. * Supervisory skills.
DUTIES: Generate evaluation report(s) for each new applications (NCE and Generics) in compliance with required template and adopted regulatory /scientific standards and submit for peer review. * Following peer review process amend the report (s) accordingly to generate a list of queries to the applicant using the correct templates. * Peer-review primary report (s) done by other reviewers. * Prepare report for the internal working groups and where necessary present at advisory committee for complex scientific matters. * Prepare query letter to the applicant. * Prepare a basis of approval or rejection. * Provide quality assurance of reports and facilitate resolutions on technical matters.
Generate second (and subsequent) evaluation report (s) for each response application and submit for peer review in compliance with required template and adopted regulatory /scientific standards and submit for peer review. * Following peer review process amend the report accordingly to generate a list of queries to the applicant, if necessary; * Peer review other evaluators response reports, according to the required template and adopted regulatory/scientific standards. * Prepare report for the internal working groups and where necessary present at advisory committee for complex scientific matters. * Prepare query letter to the applicant. * Prepare a basis of approval or rejection. Provide quality assurance of reports and facilitate resolutions on technical matters.
Generate technical screening evaluation report(s) for each application and submit for peer review. * Following peer review process amend the technical screening report (s) accordingly to generate a list of queries to the applicant using the correct templates. * Peer-review technical screening report (s) done by other reviewers. * Prepare screening query / screening rejection letter to the applicant. * Provide quality assurance of reports and facilitate resolutions on technical matters.
Review existing guidelines, SOPs and templates and update when necessary. * Provide training on guidelines, SOPs and templates. * Create new guidelines, SOPs and templates where relevant. * Provide regular work-plans and output to the unit manager (qualitative and quantities report). * Perform any other related duty as requested by manager/senior manager.
Participate in special projects and registration group. * Lead and manage assessments peer review and discussion working group where relevant. * Compile discussion documents and reports. * Provide regular trainings to new internal MRO’s and external evaluators. * Take comprehensive notes of discussions of relevant discussions. * Prepare documents for SAHPRA management/ RC meeting.
SOP’s and Guidelines must be adhered to. * Create and maintain data bases. * Use the most current templates and guidelines. * Provide and attend relevant training as may be necessary. * Align with QMS requirements. Align with ICH, WHO, IPRP and international standards.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names and email addresses of 3 referees and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
• Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: The closing date has been extended to the 12 January 2024 at 16H00. SAHPRA apologies for any inconvenience caused.
Re- Advertisement of Ref no:. SAHPRA 058-2023. Candidates who previously applied are encouraged to reapply.
MEDICINES CONTROL OFFICER:
REGULATORY COMPLIANCE X3
(FIXED TERM CONTRACT POSITIONS – ENDING MARCH 2025)
SALARY: R 657 376.00 – R834 199.00 per annum. (TOTAL COST TO COMPANY)
(Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service.
Ref No.: SAHPRA 068/2023
CENTRE: Pretoria
Requirements: Matric certificate and appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) or / equivalent related Honours Degree in Health Science at NQF level 8 as recognised by SAQA. A relevant Master’s qualification will be an added advantage.
Grade 1 – 4-year Bachelor of Pharmacy Degree NQF or Honours Degree or / equivalent related Honours Degree in Health Science at NQF level 8 as recognised by SAQA plus a minimum of five (5) of experience as a practicing pharmacist post Community Service. Sound knowledge of the Medicines and Related Substances Act 101 of 1965 as amended and regulations pertaining to the Act.
Grade 2 - 4-year Bachelor of Pharmacy Degree NQF level 8 as recognised by SAQA and registration as a Pharmacist with South African Pharmacy Council (SAPC) and minimum of three (3) years of experience in as a practicing pharmacist post Community Service. Sound knowledge of the Medicines and Related Substances Act 101 of 1965 as amended and regulations pertaining to the Act or Honours Degree in Health Science at NQF level 8 as recognised by SAQA plus a minimum of ten (10) years of experience as a practicing pharmacist post Community Service. Sound knowledge of the Medicines and Related Substances Act 101 of 1965 as amended and regulations pertaining to the Act.
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES: Comprehensive and sound knowledge of all relevant legislation, protocols, regulations, and guidelines pertaining to the Medicines and Related Substances Act 101 of 1965. * Good verbal and numerical reasoning skills to allow analysis and interpretation of written and numerical data. * Good communication skills (verbal, written, conflict management and resolution). * Resilience. * Delivery of service objectives with professional excellence and efficiency. * Ability to make effective decisions by using evidence and knowledge to support accurate, expert decisions and advice while carefully considering the implications of such a decision. * Ability to work unsupervised for long periods of time. * Ability to work within a team environment. * Good planning and organisational skills. * Ability to meet tight deadlines and manage multiple, often competing priorities. * Knowledge of MS Office. * Valid Driver’s License. * Ethical behaviour and adherence to the SAHPRA Code of Conduct.
DUTIES: Prioritise activities for preventing, detecting and responding to Substandard and Falsified health products. * Develop, review and ensure implementation of approved Standard Operating Procedures (SOPs) for market surveillance and control activities. * Investigate effectively and efficiently complaints allocated to you pertaining to contravention of the Medicines Act. * Conduct Post Market Surveillance inspections across the country and effect appropriate actions as per provisions of the Medicines Act. * Foster cooperation and collaboration with relevant SAHPRA units to enhance appropriate regulatory outcomes on matters. * Submit weekly work-plan and output to the Manage (quantitative and qualitative reports). * Submit monthly performance reports to the unit Manager. * Prepare reports for consideration by the Manager, Senior Manager, and Executives. * Participate in risk and audit queries. * Support the manager with any other matters relating to the unit expected outputs.
Ensure compliance with unit quality management system (QMS) activities. * Monitor and enforce compliance with the provisions of the Medicines Act and other related legislation through collaboration with local and international organisations: * Perform activities within approved processes of the Unit, and report to manager on improvements needed. * Liaise with SAPS, NPA, Applicants and SARS Customs officials regarding law enforcement. * Conduct training for border management personnel on handling of importation and exportation of medicines. * Participate in Education and awareness with the industry, public and health professional bodies and other stakeholders. * Communication to other government departments and healthcare industry on illegal medical products. * Foster and develop networks on pharmaceutical crime with other regulatory authorities and relevant stakeholders. Develop and maintain relations with the pharmaceutical, medical devices, complimentary medicines and other relevant stakeholders. * Investigate and attend to industry / applicants’ queries. * Participate in market surveillance and control activities inc. Interpol, UNODC, WHO, PIC/S or any relevant stakeholders.
Work with law enforcement agencies to ensure penalties are effected against offences. * Foster cooperation and collaboration with statutory bodies, industry associations, activists organisations and media. * Control and Monitoring of narcotics and psychotropics substances in accordance with the provisions of the Medicines Act. * Conduct inspections for cultivators of cannabis for producing scheduled substances and pharmaceutical companies / permit holders where schedule 5, 6, 7 & 8 substances are kept. * Compile reports and resolutions for the licensing unit. * Participate in peer reviews for applications. * Compile reports timely to all stakeholders. * Monitor consumption of these substances via consumption data reports review. * Enforce the appropriate action and report outcome to management. * Minimise risk to the organisation by ensuring the demonstration of ethical behaviour and good governance practices in line with the SAHPRA Code of Conduct.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names and email addresses of 3 referees and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
• Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: The closing date has been extended to the 12 January 2024 at 16H00. SAHPRA apologies for any inconvenience caused.
Re- Advertisement of Ref no:. SAHPRA 058-2023. Candidates who previously applied are encouraged to reapply.
MEDICINES CONTROL OFFICER:
REGULATORY COMPLIANCE X3
(FIXED TERM CONTRACT POSITIONS – ENDING MARCH 2025)
SALARY: R 657 376.00 – R834 199.00 per annum. (TOTAL COST TO COMPANY)
(Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service.
Ref No.: SAHPRA 068/2023
CENTRE: Pretoria
Requirements: Matric certificate and appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) or / equivalent related Honours Degree in Health Science at NQF level 8 as recognised by SAQA. A relevant Master’s qualification will be an added advantage.
Grade 1 – 4-year Bachelor of Pharmacy Degree NQF or Honours Degree or / equivalent related Honours Degree in Health Science at NQF level 8 as recognised by SAQA plus a minimum of five (5) of experience as a practicing pharmacist post Community Service. Sound knowledge of the Medicines and Related Substances Act 101 of 1965 as amended and regulations pertaining to the Act.
Grade 2 - 4-year Bachelor of Pharmacy Degree NQF level 8 as recognised by SAQA and registration as a Pharmacist with South African Pharmacy Council (SAPC) and minimum of three (3) years of experience in as a practicing pharmacist post Community Service. Sound knowledge of the Medicines and Related Substances Act 101 of 1965 as amended and regulations pertaining to the Act or Honours Degree in Health Science at NQF level 8 as recognised by SAQA plus a minimum of ten (10) years of experience as a practicing pharmacist post Community Service. Sound knowledge of the Medicines and Related Substances Act 101 of 1965 as amended and regulations pertaining to the Act.
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES: Comprehensive and sound knowledge of all relevant legislation, protocols, regulations, and guidelines pertaining to the Medicines and Related Substances Act 101 of 1965. * Good verbal and numerical reasoning skills to allow analysis and interpretation of written and numerical data. * Good communication skills (verbal, written, conflict management and resolution). * Resilience. * Delivery of service objectives with professional excellence and efficiency. * Ability to make effective decisions by using evidence and knowledge to support accurate, expert decisions and advice while carefully considering the implications of such a decision. * Ability to work unsupervised for long periods of time. * Ability to work within a team environment. * Good planning and organisational skills. * Ability to meet tight deadlines and manage multiple, often competing priorities. * Knowledge of MS Office. * Valid Driver’s License. * Ethical behaviour and adherence to the SAHPRA Code of Conduct.
DUTIES: Prioritise activities for preventing, detecting and responding to Substandard and Falsified health products. * Develop, review and ensure implementation of approved Standard Operating Procedures (SOPs) for market surveillance and control activities. * Investigate effectively and efficiently complaints allocated to you pertaining to contravention of the Medicines Act. * Conduct Post Market Surveillance inspections across the country and effect appropriate actions as per provisions of the Medicines Act. * Foster cooperation and collaboration with relevant SAHPRA units to enhance appropriate regulatory outcomes on matters. * Submit weekly work-plan and output to the Manage (quantitative and qualitative reports). * Submit monthly performance reports to the unit Manager. * Prepare reports for consideration by the Manager, Senior Manager, and Executives. * Participate in risk and audit queries. * Support the manager with any other matters relating to the unit expected outputs.
Ensure compliance with unit quality management system (QMS) activities. * Monitor and enforce compliance with the provisions of the Medicines Act and other related legislation through collaboration with local and international organisations: * Perform activities within approved processes of the Unit, and report to manager on improvements needed. * Liaise with SAPS, NPA, Applicants and SARS Customs officials regarding law enforcement. * Conduct training for border management personnel on handling of importation and exportation of medicines. * Participate in Education and awareness with the industry, public and health professional bodies and other stakeholders. * Communication to other government departments and healthcare industry on illegal medical products. * Foster and develop networks on pharmaceutical crime with other regulatory authorities and relevant stakeholders. Develop and maintain relations with the pharmaceutical, medical devices, complimentary medicines and other relevant stakeholders. * Investigate and attend to industry / applicants’ queries. * Participate in market surveillance and control activities inc. Interpol, UNODC, WHO, PIC/S or any relevant stakeholders.
Work with law enforcement agencies to ensure penalties are effected against offences. * Foster cooperation and collaboration with statutory bodies, industry associations, activists organisations and media. * Control and Monitoring of narcotics and psychotropics substances in accordance with the provisions of the Medicines Act. * Conduct inspections for cultivators of cannabis for producing scheduled substances and pharmaceutical companies / permit holders where schedule 5, 6, 7 & 8 substances are kept. * Compile reports and resolutions for the licensing unit. * Participate in peer reviews for applications. * Compile reports timely to all stakeholders. * Monitor consumption of these substances via consumption data reports review. * Enforce the appropriate action and report outcome to management. * Minimise risk to the organisation by ensuring the demonstration of ethical behaviour and good governance practices in line with the SAHPRA Code of Conduct.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names and email addresses of 3 referees and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
• Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: The closing date has been extended to the 12 January 2024 at 16H00. SAHPRA apologies for any inconvenience caused.
Re- Advertisement of Ref no:. SAHPRA 052-2023. Candidates who previously applied are encouraged to reapply.
GOOD MANUFACTURING PRACTICE (GMP) INSPECTOR
SALARY: R 657 376.00 – R834 199.00 per annum. (TOTAL COST TO COMPANY)
(Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service.
Ref No.: SAHPRA 065/2023
CENTRE: Pretoria
REQUIREMENTS: Matric certificate and appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) or / Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA. A relevant Master’s qualification will be an added advantage.
Grade 1 – 4-year Bachelor of Pharmacy Degree NQF or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of five (5) of experience in pharmaceutical regulatory or GMP environment. Extensive knowledge of GMP regulations and industry practice, as well as substantial experience of undertaking GMP inspections within a regulatory environment.
Grade 2 - 4-year Bachelor of Pharmacy Degree NQF level 8 as recognised by SAQA and registration as a Pharmacist with South African Pharmacy Council (SAPC) and minimum of three (3) years of experience in pharmaceutical regulatory or GMP environment. Extensive knowledge of GMP regulations and industry practice, as well as substantial experience of undertaking GMP inspections within a regulatory environment or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of ten (10) years of experience in pharmaceutical regulatory or GMP environment. Extensive knowledge of GMP regulations and industry practice, as well as substantial experience of undertaking GMP inspections within a regulatory environment.
CORE COMPETENCIES, TECHNICAL PROFICIENCIES, AND VALUES: *Comprehensive and sound knowledge of all relevant legislation, protocols, regulations, and guidelines pertaining to the Medicines and Related Substances Act 101 of 1965. *Good verbal and numerical reasoning skills to allow analysis and interpretation of written and numerical data. *Good communication skills (verbal, written, conflict management and resolution). *Resilience. *Delivery of service objectives with professional excellence and efficiency. *Ability to make effective decisions by using evidence and knowledge to support accurate, expert decisions and advice while carefully considering the implications of such a decision. *Ability to work unsupervised for long periods of time. *Ability to work within a team environment. *Good planning and organisational skills. *Ability to meet tight deadlines and manage multiple, often competing priorities. *Knowledge of MS Office. *Valid Driver’s License. *Ethical behaviour and adherence to the SAHPRA Code of Conduct. *At SAHPRA we adhere to our core values: *Ubuntu *Responsiveness *Integrity *Transparency *Efficiency *Excellence
DUTIES: Inspect pharmaceutical manufacturing sites for compliance with Good Manufacturing Practices as accepted by SAHPRA. Assess and evaluate GMP inspection reports of other regulatory authorities on international pharmaceutical manufacturing sites where medicines for exportation to South Africa are manufactured. Perform Pre- and Post-Registration inspections on information submitted in a medicine application dossier. Perform Once-Off evaluation on information submitted by HCR (Applicants). To work closely across inspection teams, SAHPRA departments and external regulators to ensure inspection activities are planned and communicated effectively. Evaluate Standard Operating Procedures (SOPs) of Inspectorate for compliance with GMP/GWP Guidelines as adopted by SAHPRA. To contribute to the Inspectorate’s compliance management process by ensuring that instances of suspected or known non-compliance are handled in the appropriate manner. Prepare reports for SAHPRA and relevant advisory committees and the Finance department. Liaise with inspectors from international regulatory authorities. Assist in minuting the recommendations of relevant advisory committees of SAHPRA applicable to the activities of the inspectorate. Interview members from the industry to discuss SAHPRA Board resolutions and requirements of the Medicine and Related Substances Act, No. 101 of 1965 [and medicines quality issues. To provide advisory support to key stakeholders, including participation in Regulatory meetings and conferences, external presentations all while demonstrating sound industry and technical knowledge. Record statistics of generated and peer-reviewed reports. Manage the associated risks and audit queries through a clear governance process, ensuring that the correct procedure is followed, care taken, and ethical behaviour demonstrated when managing inspection-related resources and that all relevant records and evidence is sufficiently maintained for audit purposes.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names and email addresses of 3 referees and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
• Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: The closing date has been extended to the 12 January 2024 at 16H00. SAHPRA apologies for any inconvenience caused.
Re- Advertisement of Ref no:. SAHPRA 052-2023. Candidates who previously applied are encouraged to reapply.
GOOD MANUFACTURING PRACTICE (GMP) INSPECTOR
SALARY: R 657 376.00 – R834 199.00 per annum. (TOTAL COST TO COMPANY)
(Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service.
Ref No.: SAHPRA 065/2023
CENTRE: Pretoria
REQUIREMENTS: Matric certificate and appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) or / Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA. A relevant Master’s qualification will be an added advantage.
Grade 1 – 4-year Bachelor of Pharmacy Degree NQF or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of five (5) of experience in pharmaceutical regulatory or GMP environment. Extensive knowledge of GMP regulations and industry practice, as well as substantial experience of undertaking GMP inspections within a regulatory environment.
Grade 2 - 4-year Bachelor of Pharmacy Degree NQF level 8 as recognised by SAQA and registration as a Pharmacist with South African Pharmacy Council (SAPC) and minimum of three (3) years of experience in pharmaceutical regulatory or GMP environment. Extensive knowledge of GMP regulations and industry practice, as well as substantial experience of undertaking GMP inspections within a regulatory environment or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of ten (10) years of experience in pharmaceutical regulatory or GMP environment. Extensive knowledge of GMP regulations and industry practice, as well as substantial experience of undertaking GMP inspections within a regulatory environment.
CORE COMPETENCIES, TECHNICAL PROFICIENCIES, AND VALUES: *Comprehensive and sound knowledge of all relevant legislation, protocols, regulations, and guidelines pertaining to the Medicines and Related Substances Act 101 of 1965. *Good verbal and numerical reasoning skills to allow analysis and interpretation of written and numerical data. *Good communication skills (verbal, written, conflict management and resolution). *Resilience. *Delivery of service objectives with professional excellence and efficiency. *Ability to make effective decisions by using evidence and knowledge to support accurate, expert decisions and advice while carefully considering the implications of such a decision. *Ability to work unsupervised for long periods of time. *Ability to work within a team environment. *Good planning and organisational skills. *Ability to meet tight deadlines and manage multiple, often competing priorities. *Knowledge of MS Office. *Valid Driver’s License. *Ethical behaviour and adherence to the SAHPRA Code of Conduct. *At SAHPRA we adhere to our core values: *Ubuntu *Responsiveness *Integrity *Transparency *Efficiency *Excellence
DUTIES: Inspect pharmaceutical manufacturing sites for compliance with Good Manufacturing Practices as accepted by SAHPRA. Assess and evaluate GMP inspection reports of other regulatory authorities on international pharmaceutical manufacturing sites where medicines for exportation to South Africa are manufactured. Perform Pre- and Post-Registration inspections on information submitted in a medicine application dossier. Perform Once-Off evaluation on information submitted by HCR (Applicants). To work closely across inspection teams, SAHPRA departments and external regulators to ensure inspection activities are planned and communicated effectively. Evaluate Standard Operating Procedures (SOPs) of Inspectorate for compliance with GMP/GWP Guidelines as adopted by SAHPRA. To contribute to the Inspectorate’s compliance management process by ensuring that instances of suspected or known non-compliance are handled in the appropriate manner. Prepare reports for SAHPRA and relevant advisory committees and the Finance department. Liaise with inspectors from international regulatory authorities. Assist in minuting the recommendations of relevant advisory committees of SAHPRA applicable to the activities of the inspectorate. Interview members from the industry to discuss SAHPRA Board resolutions and requirements of the Medicine and Related Substances Act, No. 101 of 1965 [and medicines quality issues. To provide advisory support to key stakeholders, including participation in Regulatory meetings and conferences, external presentations all while demonstrating sound industry and technical knowledge. Record statistics of generated and peer-reviewed reports. Manage the associated risks and audit queries through a clear governance process, ensuring that the correct procedure is followed, care taken, and ethical behaviour demonstrated when managing inspection-related resources and that all relevant records and evidence is sufficiently maintained for audit purposes.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names and email addresses of 3 referees and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
• Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: The closing date has been extended to the 12 January 2024 at 16H00. SAHPRA apologies for any inconvenience caused.
TECHNICAL OFFICER: LICENSING & VIGILANCE
SALARY: R 657 376.00 – R834 199.00 per annum. (TOTAL COST TO COMPANY)
(Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service.
Ref No.: SAHPRA 079/2023
CENTRE: PRETORIA
REQUIREMENTS: Matric certificate and a 4-year degree in Pharmacy or Honours Degree in Medical Sciences /Clinical engineering or related equivalent at an equivalent NQF level 8 as recognised by SAQA. Registration with the relevant body. A relevant Master’s qualification will be an added advantage.
Grade 1 - 4-year degree in Pharmacy or Honours Degree in Medical Sciences /Clinical engineering or related equivalent at an equivalent NQF level 8 as recognised by SAQA. Registration with the relevant body. Minimum three (3) years’ experience of which two (2) years’ must be regulatory in Medical Devices and IVDs. Working knowledge and/or understanding of Medical Devices Licencing, Vigilance and Post Marketing Surveillance requirements.
Grade 2 - 4-year degree in Pharmacy or Honours Degree in Medical Sciences /Clinical engineering or related equivalent at an equivalent NQF level 8 as recognised by SAQA. Registration with the relevant body. Minimum eight (8) years’ experience of which five (5) years’ must be regulatory in Medical Devices and IVDs. Working knowledge and/or understanding of Medical Devices Licencing, Vigilance and Post Marketing Surveillance requirements plus a Master’s qualification will be an added advantage.
CORE COMPETENCIES, TECHNICAL PROFICIENCIES, AND VALUES: Comprehensive knowledge and understanding of relevant legislation, Medicine and Related Substances Act 101 of 1965, Regulations relating to Medical Devices and IVDs. Computer literacy and MS windows computer skills, Excel and database applications. Good report writing and presentation skills. Good planning and organization skills. Good verbal and written communication skills. Self-motivated and able to work independently. Ability to manage a variety of cross-functional team members. Pay attention to detail and information evaluation. Valid Driver’s License. Ethical behaviour and adherence to the SAHPRA Code of Conduct. At SAHPRA we adhere to our core values: Ubuntu, Responsiveness, Integrity, Transparency, Efficiency, Excellence.
DUTIES: Perform risk-based evaluation of vigilance reports for medical devices and IVDs. Manage further handling of vigilance activities and maintain relevant databases. Develop and maintain guidelines and standard operating procedures for Medical Devices Licencing and Vigilance. Evaluate and manage licence applications for medical device establishments and maintain relevant databases. Prepare reports for SAHPRA and relevant advisory committees.
Assist in minuting the recommendations of relevant advisory committees of SAHPRA applicable to the activities of the unit. Liaise with international regulatory authorities. Communicate with the members from industry regarding the SAHPRA Board resolutions, legislative requirements for medical device and IVDs. Investigate and attend to industry / applicant’s queries. Capture and maintain data relating to measuring and monitoring of performance metrics and peer reviewed reports, and record statistics generated. Manage the associated risks and audit queries, and correspondence from applicants and stakeholders. Submit weekly work-plan and output to the Unit manager (quantitative and qualitative reports). Perform other functions that may arise from time to time.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names and email addresses of 3 referees and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
• Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: The closing date is the 12 January 2024 at 16H00.
TECHNICAL OFFICER: LICENSING & VIGILANCE
SALARY: R 657 376.00 – R834 199.00 per annum. (TOTAL COST TO COMPANY)
(Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service.
Ref No.: SAHPRA 079/2023
CENTRE: PRETORIA
REQUIREMENTS: Matric certificate and a 4-year degree in Pharmacy or Honours Degree in Medical Sciences /Clinical engineering or related equivalent at an equivalent NQF level 8 as recognised by SAQA. Registration with the relevant body. A relevant Master’s qualification will be an added advantage.
Grade 1 - 4-year degree in Pharmacy or Honours Degree in Medical Sciences /Clinical engineering or related equivalent at an equivalent NQF level 8 as recognised by SAQA. Registration with the relevant body. Minimum three (3) years’ experience of which two (2) years’ must be regulatory in Medical Devices and IVDs. Working knowledge and/or understanding of Medical Devices Licencing, Vigilance and Post Marketing Surveillance requirements.
Grade 2 - 4-year degree in Pharmacy or Honours Degree in Medical Sciences /Clinical engineering or related equivalent at an equivalent NQF level 8 as recognised by SAQA. Registration with the relevant body. Minimum eight (8) years’ experience of which five (5) years’ must be regulatory in Medical Devices and IVDs. Working knowledge and/or understanding of Medical Devices Licencing, Vigilance and Post Marketing Surveillance requirements plus a Master’s qualification will be an added advantage.
CORE COMPETENCIES, TECHNICAL PROFICIENCIES, AND VALUES: Comprehensive knowledge and understanding of relevant legislation, Medicine and Related Substances Act 101 of 1965, Regulations relating to Medical Devices and IVDs. Computer literacy and MS windows computer skills, Excel and database applications. Good report writing and presentation skills. Good planning and organization skills. Good verbal and written communication skills. Self-motivated and able to work independently. Ability to manage a variety of cross-functional team members. Pay attention to detail and information evaluation. Valid Driver’s License. Ethical behaviour and adherence to the SAHPRA Code of Conduct. At SAHPRA we adhere to our core values: Ubuntu, Responsiveness, Integrity, Transparency, Efficiency, Excellence.
DUTIES: Perform risk-based evaluation of vigilance reports for medical devices and IVDs. Manage further handling of vigilance activities and maintain relevant databases. Develop and maintain guidelines and standard operating procedures for Medical Devices Licencing and Vigilance. Evaluate and manage licence applications for medical device establishments and maintain relevant databases. Prepare reports for SAHPRA and relevant advisory committees.
Assist in minuting the recommendations of relevant advisory committees of SAHPRA applicable to the activities of the unit. Liaise with international regulatory authorities. Communicate with the members from industry regarding the SAHPRA Board resolutions, legislative requirements for medical device and IVDs. Investigate and attend to industry / applicant’s queries. Capture and maintain data relating to measuring and monitoring of performance metrics and peer reviewed reports, and record statistics generated. Manage the associated risks and audit queries, and correspondence from applicants and stakeholders. Submit weekly work-plan and output to the Unit manager (quantitative and qualitative reports). Perform other functions that may arise from time to time.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names and email addresses of 3 referees and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
• Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: The closing date is the 12 January 2024 at 16H00.
Re- Advertisement of Ref no:. SAHPRA 015-2023. Candidates who previously applied are encouraged to reapply.
GOOD CLINICAL PRACTICE (GCP) INSPECTOR
SALARY: R 657 376.00 – R834 199.00 per annum. (TOTAL COST TO COMPANY)
FIXED-TERM CONTRACT (ENDS IN MARCH 2025)
(Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service.
Ref No.: SAHPRA 066/2023
CENTRE: Pretoria
REQUIREMENTS: Matric certificate and appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) or / Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA. A relevant Master’s qualification will be an added advantage.
Grade 1 – 4-year Bachelor of Pharmacy Degree NQF or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of five (5) of experience in experience in clinical trials and bio-equivalence studies. Extensive knowledge of GxP regulations and industry practices, as well as substantial experience of undertaking GxP inspections within the regulatory environment.
Grade 2 - 4-year Bachelor of Pharmacy Degree NQF level 8 as recognised by SAQA and registration as a Pharmacist with South African Pharmacy Council (SAPC) and minimum of three (3) years of experience in clinical trials and bio-equivalence studies. Extensive knowledge of GxP regulations and industry practices, as well as substantial experience of undertaking GxP inspections within the regulatory environment or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of ten (10) years of experience in clinical trials and bio-equivalence studies. Extensive knowledge of GxP regulations and industry practices, as well as substantial experience of undertaking GxP inspections within the regulatory environment.
CORE COMPETENCIES, TECHNICAL PROFICIENCIES, AND VALUES: * Comprehensive and Sound knowledge of all relevant legislation, regulations and guidelines pertaining to the Medicines and Related Substances Act 101 of 1965. *Good verbal and numerical reasoning skills to allow analysis and interpretation of written and numerical data. Good communication skills (verbal, written, conflict management and resolution). Delivery of service objectives with professional excellence and efficiency. *Ability to make effective decisions by using evidence and knowledge to support accurate, expect decisions and advice while carefully considering the implications of such a decision. Ability to work unsupervised for long periods of time. *Ability to work within a team environment. *Good planning and organisational skills. *Ability to meet tight deadlines and manage multiple, often competing priorities. *Knowledge of MS Office. *Valid driver’s license. *Ethical behaviour and adherence to the SAHPRA Code of Conduct
DUTIES: • Inspect clinical trial vendors, laboratories, and other identified sites for compliance with Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) as accepted by SAHPRA. • Assess and evaluate GCP inspection reports of other regulatory authorities on international bioequivalent trials to verify clinical data to support registration of medicines in South Africa. • Work closely across inspection teams, SAHPRA departments and external regulators to ensure inspection activities are planned and communicated effectively • Evaluate Standard Operating Procedure (SOPs) of Inspectorate for compliance with GCP Guidelines as adopted by SAHPRA.• To contribute to the inspectorate’s compliance management process by ensuring that instances of suspected or known non-compliance are handled in the appropriate manner. • To prepare reports for SAHPRA and relevant advisory committees and the Finance department. • Liaise with inspectors from international regulatory authorities. • Assist in minuting the recommendations of relevant advisory committees of SAHPRA applicable to the activities of the inspectorate.• Interview members from the industry to discuss requirements of the Medicine and Related Substances Act, No. 101 of 1965. • To provide advisory support to key stakeholders, including participation in regulatory meetings and conferences, external presentation all while demonstrating sound industry and technical knowledge. • Record statistics of generated and peer-reviewed reports.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names and email addresses of 3 referees and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
• Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: The closing date has been extended to the 12 January 2024 at 16H00. SAHPRA apologies for any inconvenience caused.
Re- Advertisement of Ref no:. SAHPRA 015-2023. Candidates who previously applied are encouraged to reapply.
GOOD CLINICAL PRACTICE (GCP) INSPECTOR
SALARY: R 657 376.00 – R834 199.00 per annum. (TOTAL COST TO COMPANY)
FIXED-TERM CONTRACT (ENDS IN MARCH 2025)
(Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service.
Ref No.: SAHPRA 066/2023
CENTRE: Pretoria
REQUIREMENTS: Matric certificate and appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) or / Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA. A relevant Master’s qualification will be an added advantage.
Grade 1 – 4-year Bachelor of Pharmacy Degree NQF or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of five (5) of experience in experience in clinical trials and bio-equivalence studies. Extensive knowledge of GxP regulations and industry practices, as well as substantial experience of undertaking GxP inspections within the regulatory environment.
Grade 2 - 4-year Bachelor of Pharmacy Degree NQF level 8 as recognised by SAQA and registration as a Pharmacist with South African Pharmacy Council (SAPC) and minimum of three (3) years of experience in clinical trials and bio-equivalence studies. Extensive knowledge of GxP regulations and industry practices, as well as substantial experience of undertaking GxP inspections within the regulatory environment or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of ten (10) years of experience in clinical trials and bio-equivalence studies. Extensive knowledge of GxP regulations and industry practices, as well as substantial experience of undertaking GxP inspections within the regulatory environment.
CORE COMPETENCIES, TECHNICAL PROFICIENCIES, AND VALUES: * Comprehensive and Sound knowledge of all relevant legislation, regulations and guidelines pertaining to the Medicines and Related Substances Act 101 of 1965. *Good verbal and numerical reasoning skills to allow analysis and interpretation of written and numerical data. Good communication skills (verbal, written, conflict management and resolution). Delivery of service objectives with professional excellence and efficiency. *Ability to make effective decisions by using evidence and knowledge to support accurate, expect decisions and advice while carefully considering the implications of such a decision. Ability to work unsupervised for long periods of time. *Ability to work within a team environment. *Good planning and organisational skills. *Ability to meet tight deadlines and manage multiple, often competing priorities. *Knowledge of MS Office. *Valid driver’s license. *Ethical behaviour and adherence to the SAHPRA Code of Conduct
DUTIES: • Inspect clinical trial vendors, laboratories, and other identified sites for compliance with Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) as accepted by SAHPRA. • Assess and evaluate GCP inspection reports of other regulatory authorities on international bioequivalent trials to verify clinical data to support registration of medicines in South Africa. • Work closely across inspection teams, SAHPRA departments and external regulators to ensure inspection activities are planned and communicated effectively • Evaluate Standard Operating Procedure (SOPs) of Inspectorate for compliance with GCP Guidelines as adopted by SAHPRA.• To contribute to the inspectorate’s compliance management process by ensuring that instances of suspected or known non-compliance are handled in the appropriate manner. • To prepare reports for SAHPRA and relevant advisory committees and the Finance department. • Liaise with inspectors from international regulatory authorities. • Assist in minuting the recommendations of relevant advisory committees of SAHPRA applicable to the activities of the inspectorate.• Interview members from the industry to discuss requirements of the Medicine and Related Substances Act, No. 101 of 1965. • To provide advisory support to key stakeholders, including participation in regulatory meetings and conferences, external presentation all while demonstrating sound industry and technical knowledge. • Record statistics of generated and peer-reviewed reports.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names and email addresses of 3 referees and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
• Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: The closing date has been extended to the 12 January 2024 at 16H00. SAHPRA apologies for any inconvenience caused.
Re- Advertisement of Ref no:. SAHPRA 047-2023. Candidates who previously applied are encouraged to reapply.
MEDICINE REGISTRATION OFFICER
NAMES AND SCHEDULING
SALARY: R 657 376.00 – R834 199.00 per annum. (TOTAL COST TO COMPANY) (Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service.
Ref No.: SAHPRA 072/2023
CENTRE: Pretoria
Requirements: Matric certificate and appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) at NQF level 8 as recognised by SAQA. A relevant Master’s qualification will be an added advantage.
Grade 1 – 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) at NQF level 8 as recognised by SAQA plus a minimum of four (4) years of relevant experience of which one (1) in regulatory.
Grade 2 – 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) at NQF level 8 as recognised by SAQA plus a minimum of eight (8) years of relevant experience of which two (2) in regulatory.
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES: Knowledge and application of the Medicines and Related Substances Control Act (101 of 1965), as amended, and its related Regulations, with respect to the regulation of medicines in terms of quality, safety, and efficacy. * Knowledge of technical aspects for evaluation of quality and efficacy of bioequivalence of medicines. * Comprehensive knowledge and understanding of relevant legislation, guidelines, protocols, standard operating procedures, and work instructions as outlined by regulatory authorities. * Good planning, organizational and interpersonal skills. * Initiative-taking and able to work independently. * Good communication skills (written, verbal, negotiation, conflict management, presentation). * Innovative thinking, initiative, assertive and leadership qualities. * Dedication and accurate work. * Ethical behaviour. * Must be willing to travel and work irregular hours. * Customer service. * Planning and organizing skills
DUTIES: Generate evaluation report(s) for each new applications (Generics) in compliance with required template and adopted regulatory /scientific standards and submit for peer review. Following peer review process amend the report (s) accordingly to generate a list of queries to the applicant using the correct templates. Prepare report for the internal working groups and where necessary present at advisory committee for complex scientific matters. Provide quality assurance of reports and facilitate resolutions on technical matters. Generate evaluation report(s) for each new applications (Generics) in compliance with required template and adopted regulatory /scientific standards and submit for peer review. Following peer review process amend the report (s) accordingly to generate a list of queries to the applicant using the correct templates. Prepare report for the internal working groups and where necessary present at advisory committee for complex scientific matters. Provide quality assurance of reports and facilitate resolutions on technical matters.
Generate second (and subsequent) evaluation report (s) for each response application and submit for peer review in compliance with required template and adopted regulatory /scientific standards and submit for peer review. Peer review other evaluators response reports, according to the required template and adopted regulatory/scientific standards. Prepare report for the internal working groups and where necessary present at advisory committee for complex scientific matters. Prepare query letter to the applicant. Provide quality assurance of reports and facilitate resolutions on technical matters. Participate in special projects and registration group. Lead and manage assessments peer review and discussion working group where relevant. Compile discussion documents and reports. Provide regular trainings to new internal MRO’s and external evaluators. Take comprehensive notes of discussions of relevant discussions. Prepare documents for SAHPRA management/ RC meeting.
Review existing guidelines, SOPs and templates and update when necessary. Provide training on guidelines, SOPs, and templates. Create new guidelines, SOPs, and templates where SOPs aren’t in place. Provide regular work-plans and output to the unit manager (qualitative and quantities report). Perform any other related duty as requested by manager/senior manager. Attend and support the internal and external Audit, including resolution of queries. Manage and keep records regularly of clinical trial related activities. Investigate and advise pharmaceutical industry / applicant’s queries or other members of the Public. Manage resolution of the queries in area of work. Provide advice or recommend to inspectorate or regulatory compliance unit. Represent SAHPRA in the local, regional and/or global sphere. Arrange and attend Industry Task Group working groups and external stakeholder meetings.
Review the request from the applicant and prepare a report/document for Advisory Naming and Scheduling Committee. Capture the final recommendation from the Advisory Naming and Scheduling Committee. Prepare a referral letter to Advisory Clinical Committee or any other relevant advisory committee. Consolidate the reports and submit to registration committee’s approval/rejection. Liaise with relevant stakeholder on the outcome of the request. Prepare a submission to Minister of Health for approval of amendments on consolidated schedule.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names and email addresses of 3 referees and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
• Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: The closing date has been extended to the 12 January 2024 at 16H00. SAHPRA apologies for any inconvenience caused.
Re- Advertisement of Ref no:. SAHPRA 047-2023. Candidates who previously applied are encouraged to reapply.
MEDICINE REGISTRATION OFFICER
NAMES AND SCHEDULING
SALARY: R 657 376.00 – R834 199.00 per annum. (TOTAL COST TO COMPANY) (Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service.
Ref No.: SAHPRA 072/2023
CENTRE: Pretoria
Requirements: Matric certificate and appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) at NQF level 8 as recognised by SAQA. A relevant Master’s qualification will be an added advantage.
Grade 1 – 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) at NQF level 8 as recognised by SAQA plus a minimum of four (4) years of relevant experience of which one (1) in regulatory.
Grade 2 – 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) at NQF level 8 as recognised by SAQA plus a minimum of eight (8) years of relevant experience of which two (2) in regulatory.
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES: Knowledge and application of the Medicines and Related Substances Control Act (101 of 1965), as amended, and its related Regulations, with respect to the regulation of medicines in terms of quality, safety, and efficacy. * Knowledge of technical aspects for evaluation of quality and efficacy of bioequivalence of medicines. * Comprehensive knowledge and understanding of relevant legislation, guidelines, protocols, standard operating procedures, and work instructions as outlined by regulatory authorities. * Good planning, organizational and interpersonal skills. * Initiative-taking and able to work independently. * Good communication skills (written, verbal, negotiation, conflict management, presentation). * Innovative thinking, initiative, assertive and leadership qualities. * Dedication and accurate work. * Ethical behaviour. * Must be willing to travel and work irregular hours. * Customer service. * Planning and organizing skills
DUTIES: Generate evaluation report(s) for each new applications (Generics) in compliance with required template and adopted regulatory /scientific standards and submit for peer review. Following peer review process amend the report (s) accordingly to generate a list of queries to the applicant using the correct templates. Prepare report for the internal working groups and where necessary present at advisory committee for complex scientific matters. Provide quality assurance of reports and facilitate resolutions on technical matters. Generate evaluation report(s) for each new applications (Generics) in compliance with required template and adopted regulatory /scientific standards and submit for peer review. Following peer review process amend the report (s) accordingly to generate a list of queries to the applicant using the correct templates. Prepare report for the internal working groups and where necessary present at advisory committee for complex scientific matters. Provide quality assurance of reports and facilitate resolutions on technical matters.
Generate second (and subsequent) evaluation report (s) for each response application and submit for peer review in compliance with required template and adopted regulatory /scientific standards and submit for peer review. Peer review other evaluators response reports, according to the required template and adopted regulatory/scientific standards. Prepare report for the internal working groups and where necessary present at advisory committee for complex scientific matters. Prepare query letter to the applicant. Provide quality assurance of reports and facilitate resolutions on technical matters. Participate in special projects and registration group. Lead and manage assessments peer review and discussion working group where relevant. Compile discussion documents and reports. Provide regular trainings to new internal MRO’s and external evaluators. Take comprehensive notes of discussions of relevant discussions. Prepare documents for SAHPRA management/ RC meeting.
Review existing guidelines, SOPs and templates and update when necessary. Provide training on guidelines, SOPs, and templates. Create new guidelines, SOPs, and templates where SOPs aren’t in place. Provide regular work-plans and output to the unit manager (qualitative and quantities report). Perform any other related duty as requested by manager/senior manager. Attend and support the internal and external Audit, including resolution of queries. Manage and keep records regularly of clinical trial related activities. Investigate and advise pharmaceutical industry / applicant’s queries or other members of the Public. Manage resolution of the queries in area of work. Provide advice or recommend to inspectorate or regulatory compliance unit. Represent SAHPRA in the local, regional and/or global sphere. Arrange and attend Industry Task Group working groups and external stakeholder meetings.
Review the request from the applicant and prepare a report/document for Advisory Naming and Scheduling Committee. Capture the final recommendation from the Advisory Naming and Scheduling Committee. Prepare a referral letter to Advisory Clinical Committee or any other relevant advisory committee. Consolidate the reports and submit to registration committee’s approval/rejection. Liaise with relevant stakeholder on the outcome of the request. Prepare a submission to Minister of Health for approval of amendments on consolidated schedule.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names and email addresses of 3 referees and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
• Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: The closing date has been extended to the 12 January 2024 at 16H00. SAHPRA apologies for any inconvenience caused.
.
Re- Advertisement of Ref no:. SAHPRA 048-2023. Candidates who previously applied are encouraged to reapply.
MEDICINES REGISTRATION OFFICER
CLINICAL EVALUATION MANAGEMENT: SECTION 21 UNIT
SALARY: R 657 376.00 – R834 199.00 per annum. (TOTAL COST TO COMPANY)
(Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service.
Ref No.: SAHPRA 073/2023
CENTRE: Pretoria
REQUIREMENTS: ● Matric certificate and appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) or / an MBChB degree and registration as a Medical Officer with the Health Professional Council of South Africa (HPCSA). A postgraduate qualification in pharmacology or related will be an added advantage.
Grade 1 – 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) or / an MBChB degree and registration as a Medical Officer with the Health Professional Council of South Africa (HPCSA). Minimum of four (4) years experience in the hospital setting or clinical research setting (post community service) of which one (1) year in regulatory.
Grade 2 – 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) or / an MBChB degree and registration as a Medical Officer with the Health Professional Council of South Africa (HPCSA). Minimum of eight (8) years of experience in the hospital setting or clinical research setting (post community service) of which two (2) years in regulatory.
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES: *Sound and in-depth knowledge of the Medicines and Related Substances Act 101, 1965 as amended and the regulations pertaining to the Act. *Sound knowledge of regulatory scientific and technical requirement (in terms of quality, safety and efficacy aspect). *Good knowledge of the regulatory requirements of the use of an unregistered medicine, i.e., Section 21 of the Medicines Act and Regulation 29 of the General Medicines Regulations. *A solid understanding of application procedures. *Section 21 application technical evaluation skills.
*Planning and organising skills. *Performance measurement skills. *Self-motivated and able to work independently. *Team management. *Competent in problem solving and team building. *Decision making. *Objectivity. *Prepared to travel and work irregular hours. *Drive and self-management skills. *Resilience. *Communication skills (verbal, written, negotiation, conflict management, presentation). *Interpersonal skills. *Assertiveness. *Ethical behaviour. *Customer service. *Knowledge of MS Office. *A valid driver’s license.
DUTIES: OUTPUT 1: Technical screening of section 21 applications. Evaluation of Section 21 applications based on review of data from multiple sources. Research Section 21 applications for new unregistered medicines. Liaise with experts (internal and external) on high-priority applications. Attend to and review written Section 21 queries, e.g., procedural, new products, monitor Section 21 email inbox. Compile Section 21 agenda documents for presentation at Clinical Trials Committee meeting or SAHPRA internal discussions. Prepare minutes of the CTC meeting pertaining to Section 21 resolutions. Prepare letter/s to relevant stakeholders communicating CTC meeting resolutions or expert discussion on Section 21 issues. Liaise with experts on high-priority applications.
OUTPUT 2: Conduct monitoring and evaluation of the unit’s activities as per Annual performance Plan, Operational Plan, revenue-generating requirements and risk register entries on a monthly and quarterly basis. Draft policy documents as pertains to section 21 authorizations (SOPs, guidelines, legislation amendments). Contribute to optimal submission of proof of payment source document (section 21 applications) to the Finance unit.
OUTPUT 3: Supervise admin staff in the Section 21 unit. Play an active role with stakeholder engagement, awareness and outreach programs (e.g., applicants, pharmaceutical industry, NDoH, etc.).
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names and email addresses of 3 referees and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
• Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment. SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: The closing date has been extended to the 12 January 2024 at 16H00. SAHPRA apologies for any inconvenience caused.
.
Re- Advertisement of Ref no:. SAHPRA 048-2023. Candidates who previously applied are encouraged to reapply.
MEDICINES REGISTRATION OFFICER
CLINICAL EVALUATION MANAGEMENT: SECTION 21 UNIT
SALARY: R 657 376.00 – R834 199.00 per annum. (TOTAL COST TO COMPANY)
(Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service.
Ref No.: SAHPRA 073/2023
CENTRE: Pretoria
REQUIREMENTS: ● Matric certificate and appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) or / an MBChB degree and registration as a Medical Officer with the Health Professional Council of South Africa (HPCSA). A postgraduate qualification in pharmacology or related will be an added advantage.
Grade 1 – 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) or / an MBChB degree and registration as a Medical Officer with the Health Professional Council of South Africa (HPCSA). Minimum of four (4) years experience in the hospital setting or clinical research setting (post community service) of which one (1) year in regulatory.
Grade 2 – 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) or / an MBChB degree and registration as a Medical Officer with the Health Professional Council of South Africa (HPCSA). Minimum of eight (8) years of experience in the hospital setting or clinical research setting (post community service) of which two (2) years in regulatory.
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES: *Sound and in-depth knowledge of the Medicines and Related Substances Act 101, 1965 as amended and the regulations pertaining to the Act. *Sound knowledge of regulatory scientific and technical requirement (in terms of quality, safety and efficacy aspect). *Good knowledge of the regulatory requirements of the use of an unregistered medicine, i.e., Section 21 of the Medicines Act and Regulation 29 of the General Medicines Regulations. *A solid understanding of application procedures. *Section 21 application technical evaluation skills.
*Planning and organising skills. *Performance measurement skills. *Self-motivated and able to work independently. *Team management. *Competent in problem solving and team building. *Decision making. *Objectivity. *Prepared to travel and work irregular hours. *Drive and self-management skills. *Resilience. *Communication skills (verbal, written, negotiation, conflict management, presentation). *Interpersonal skills. *Assertiveness. *Ethical behaviour. *Customer service. *Knowledge of MS Office. *A valid driver’s license.
DUTIES: OUTPUT 1: Technical screening of section 21 applications. Evaluation of Section 21 applications based on review of data from multiple sources. Research Section 21 applications for new unregistered medicines. Liaise with experts (internal and external) on high-priority applications. Attend to and review written Section 21 queries, e.g., procedural, new products, monitor Section 21 email inbox. Compile Section 21 agenda documents for presentation at Clinical Trials Committee meeting or SAHPRA internal discussions. Prepare minutes of the CTC meeting pertaining to Section 21 resolutions. Prepare letter/s to relevant stakeholders communicating CTC meeting resolutions or expert discussion on Section 21 issues. Liaise with experts on high-priority applications.
OUTPUT 2: Conduct monitoring and evaluation of the unit’s activities as per Annual performance Plan, Operational Plan, revenue-generating requirements and risk register entries on a monthly and quarterly basis. Draft policy documents as pertains to section 21 authorizations (SOPs, guidelines, legislation amendments). Contribute to optimal submission of proof of payment source document (section 21 applications) to the Finance unit.
OUTPUT 3: Supervise admin staff in the Section 21 unit. Play an active role with stakeholder engagement, awareness and outreach programs (e.g., applicants, pharmaceutical industry, NDoH, etc.).
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names and email addresses of 3 referees and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
• Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment. SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: The closing date has been extended to the 12 January 2024 at 16H00. SAHPRA apologies for any inconvenience caused.
RADIATION SCIENTIST
SALARY: R 832 300.00 – R883 379.00 per annum. (TOTAL COST TO COMPANY)
Ref No.: SAHPRA 061/2023
CENTRE: PRETORIA
REQUIREMENTS: Matric certificate and Degree in Clinical Engineering/ Biomedical Engineering/Diagnostic Radiographer or related equivalent qualification at NQF level 8 as recognised by SAQA. Registration with the relevant professional body.
EXPERIENCE: Minimum of five (5) years working as Clinical Engineer/Biomedical Engineer/Diagnostic Radiographer, of which one (1) year must be at supervisory level. Working knowledge of and experience with relevant national legislation and international standards. Working knowledge of Computer skills.
CORE COMPETENCIES, TECHNICAL PROFICIENCIES, AND VALUES: Comprehensive knowledge and understanding of relevant legislation, protocols, standard operating procedures, and work instructions. Self-motivated and able to work independently. Ability to manage a variety of cross-functional team members. Competent in problem solving, research skills and team building. Attention to detail, Information evaluation Decision making, Objectivity, Resilience, Communication skills (verbal, written, negotiation, conflict management, presentation). Interpersonal skills. Assertiveness, Ethical behaviour, Customer service, Planning and organising skills. Team management, MS Office. Valid Driver’s License. Ethical behaviour and adherence to the SAHPRA Code of Conduct. At SAHPRA we adhere to our core values: Ubuntu, Responsiveness, Integrity, Transparency, Efficiency, Excellence.
DUTIES: Evaluation and review of licence applications of listed electronic products for non-ionizing radiation devices. Utilize database to process licence applications for listed electronic products. Develop and review SOPs and Guidelines related to regulations of listed electronic products. Support the Deputy manager and Senior manager to respond to the queries from the industry related to the listed electronic products. Engage with industry stakeholders through training/workshop to enhance compliance with regulatory requirements of listed electronic products for non-ionizing devices. Receive and investigate an adverse event related to listed products. Participate in offering advises and training/workshop to industry stakeholders related to the subunit.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names and email addresses of 3 referees and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
• Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: The closing date is the 12 January 2024 at 16H00.
Re- Advertisement of Ref no:. SAHPRA 042-2023. Candidates who previously applied are encouraged to reapply.
TECHNICAL OFFICER: MEDICAL DEVICES CLINICAL TRIALS
SALARY: R 657 376.00 – R834 199.00 per annum. (TOTAL COST TO COMPANY)
(Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service.
Ref No.: SAHPRA 078/2023
CENTRE: Pretoria
Requirements: Matric certificate and appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) or / Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA. A relevant Master’s qualification will be an added advantage.
Grade 1 – 4-year Bachelor of Pharmacy Degree NQF or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of five (5) of experience in pharmaceutical regulatory environment. Training in (i) regulation and/or registration of medical devices and (ii) assessment of quality, safety, performance of medical devices.
Grade 2 - 4-year Bachelor of Pharmacy Degree NQF level 8 as recognised by SAQA and registration as a Pharmacist with South African Pharmacy Council (SAPC) and minimum of three (3) years of experience in pharmaceutical regulatory environment. Training in (i) regulation and/or registration of medical devices and (ii) assessment of quality, safety, performance of medical devices or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of ten (10) years of experience in pharmaceutical regulatory environment. Training in (i) regulation and/or registration of medical devices and (ii) assessment of quality, safety, performance of medical devices
COMPETENCIES (KNOWLEDGE, SKILLS AND ABILITIES): * Comprehensive knowledge and understanding of relevant legislation, standard operating procedures and work instructions. * Preparation of financial reports. * Performance measurement skills. * Self-motivated and able to work independently. * Ability to work with a variety of cross-functional team members. * Competent in problem solving. * Information evaluation. * Decision making. * Objectivity. * Resilience. * Communication skills (verbal, written, negotiation, conflict management, presentation). * Interpersonal skills. * Assertiveness. * Ethical behaviour. * Customer service. * Planning and organising skills.
DUTIES: Develop and maintain guidelines and standard operating procedures for medical device and IVD clinical trials. (Quality Management: * Internal review, draft, creation of new Guidelines and publications. * Review and drafting of SOPS related to technical review. * Call up notices for 1st phase drafted and review. * Phase drafted and review. *Review of MOU). Technical screening of new clinical trial applications and allocation of clinical trials to the evaluators. Finalisation of medical device clinical trials within 60 days (including RUO) Review protocol amendments and additional investigators and site. Attend to queries addressed concerning Clinical Trials Unit. Evaluate and manage applications for clinical trials of medical devices and IVDs and maintain relevant databases. To evaluate applications for clinical trials for medical devices being conducted in South Africa or Outside South Africa, if necessary. Support the work of committee (CEC and MDC): Prepare reports for SAHPRA and relevant advisory committees. Liaise with international regulatory authorities. Assist in minuting the recommendations of relevant advisory committees of SAHPRA applicable to the activities of the unit (Recommendations sent to application in a timely manner). Interview members from industry to discuss SAHPRA Board resolutions, requirements of the Act and medical device and IVD clinical trial issues. Investigate and attend to industry / applicant’s queries. Perform other relevant functions that may arise from time to time. Capture and maintain data relating to measuring and monitoring performance metrics and peer reviewed reports, and record statistics generated, including the units quarterly report and monthly financial reports. Manage the associated risks and audit queries, and correspondence from applicants and stakeholders. Submit weekly work-plan and output to the Unit manager (quantitative and qualitative reports). Internal Audit: * No. of audit findings per internal audit per quarter (Technical Related). * Monthly Finance reporting.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names and email addresses of 3 referees and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
• Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: The closing date has been extended to the 12 January 2024 at 16H00. SAHPRA apologies for any inconvenience caused.
Re- Advertisement of Ref no:. SAHPRA 037-2023. Candidates who previously applied are encouraged to reapply.
MEDICINES REGISTRATION OFFICER
PHARMACOVIGILANCE
SALARY: R 657 376.00 – R834 199.00 per annum. (TOTAL COST TO COMPANY) (Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service.
Ref No.: SAHPRA 069/2023
CENTRE: Pretoria
REQUIREMENTS: • Matric certificate and appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) or / Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA. • A postgraduate qualification in relevant Science or equivalent is an added advantage.
Grade 1: – 4-year Bachelor of Pharmacy Degree NQF or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of five (5) of experience in regulatory of which two (2) year must be in pharmacovigilance. Training in pharmacovigilance. • Knowledge and application of the Medicines and Related Substances Act (Act 101 of 1965) as amended and its Regulations. • Knowledge of quality, safety, and efficacy aspects of medicines. • Knowledge of medicines registration with respect to safety and efficacy of medicines. • Experience in drafting medical industry communications and articles.
Grade 2: 4-year Bachelor of Pharmacy Degree NQF level 8 as recognised by SAQA and registration as a Pharmacist with South African Pharmacy Council (SAPC) and minimum of three (3) years’ experience in regulatory of which one (1) year must be in pharmacovigilance or Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of ten (10) years of experience in regulatory of which three (3) years must be in pharmacovigilance. Training in pharmacovigilance. • Knowledge and application of the Medicines and Related Substances Act (Act 101 of 1965) as amended and its Regulations. • Knowledge of quality, safety, and efficacy aspects of medicines. • Knowledge of medicines registration with respect to safety and efficacy of medicines. • Experience in drafting medical industry communications and articles.
COMPETENCIES, KNOWLEDGE AND SKILLS: * Comprehensive and sound knowledge of all relevant legislation, protocols, regulations, and guidelines pertaining to the Medicines and Related Substances Act, Act 101 of 1965.
DUTIES: • Individual case safety reports management: * Processing of adverse drug events reports. * Clinical case assessment of adverse drug reaction reports and feedback provision to reporters. * Signal detection and management. * Reporter follow-up and system update. • Benefit-Risk assessment: * Investigate and review medicines safety concerns and prepare review reports for peer review and/or Pharmacovigilance Technical Advisory Committee discussions. * Peer review technical reports. * Technical support to the Pharmacovigilance Technical Advisory Committee. * Publication of safety regulatory decisions made by the Authority. • Medicine Safety Communication: * Draft, finalise and communicate safety communication documents (DHCPL, Newsletter, Articles, MSAs, Media Queries, Press release) as per the guiding principles. • PV stakeholder management: * Identify key stakeholder for engagements. * Arrange/participate in the stakeholder engagements. * Record/Minute the discussions and action plans. * Ensure implementation and follow-up of resolutions. • Promote PV awareness and outreach: * Develop a quarterly PV awareness and outreach plan. * Develop/update PV training materials. * Train healthcare professionals and the public on pharmacovigilance. * Coordinate medicine safety webinars. • Development and maintenance of guiding principles (SOPs, guidelines, policies, etc.) to ensure consistency, efficiency and alignment of PV processes: * Identify and implement new approaches to improve and maintain high levels of operational efficiency and effectiveness. * Update policy documents in line with international standards to improve and maintain high levels of operational efficiency and effectiveness. * Development and maintenance of guiding principles (SOPs, guidelines, policies, etc.) to ensure consistency, efficiency and alignment of PV processes. * Good verbal and numerical reasoning skills to allow analysis and interpretation of written and numerical data. * Delivery of service objectives with professional excellence and efficiency. * Ability to make effective decisions by using evidence and knowledge to support accurate, expert decisions and advice while carefully considering the implications of such a decision. * Good planning and organisational skills. * Ability to work unsupervised for long periods of time. * Promoting a more proactive, service oriented and performance-based management culture. * Good, effective communication skills (verbal, written, conflict management and resolution). * Ability to meet tight deadlines and manage multiple, often competing priorities. * Ability to work within a team environment. * Ethical behaviour and adherence to the SAHPRA Code of Conduct. * Proficient knowledge of MS Office. *A valid Driver’s License.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names and email addresses of 3 referees and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
• Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: The closing date has been extended to the 12 January 2024 at 16H00. SAHPRA apologies for any inconvenience caused.