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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.
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.
• Applications must be submitted by email to recruitment@sahpra.org.za, including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS.
• 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: 18 December 2023 at 16H00.
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.
• Applications must be submitted by email to recruitment@sahpra.org.za, including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS.
• 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: 18 December 2023 at 16H00.
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.
• Applications must be submitted by email to recruitment@sahpra.org.za, including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS.
• 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: 18 December 2023 at 16H00.
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.
• Applications must be submitted by email to recruitment@sahpra.org.za, including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS.
• 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: 18 December 2023 at 16H00.
MEDICINES REGISTRATION OFFICER
PHARMACEUTICAL EVALUATION MANAGEMENT
PRE AND POST- REGISTRATION EVALUATION MANAGEMENT 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 074/2023
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.
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.
• Applications must be submitted by email to recruitment@sahpra.org.za, including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS.
• 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: 18 December 2023 at 16H00.
MEDICINES REGISTRATION OFFICER
PHARMACEUTICAL EVALUATION MANAGEMENT
PRE AND POST- REGISTRATION EVALUATION MANAGEMENT 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 074/2023
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.
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.
• Applications must be submitted by email to recruitment@sahpra.org.za, including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS.
• 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: 18 December 2023 at 16H00.
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.
• Applications must be submitted by email to recruitment@sahpra.org.za, including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS.
• 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: 18 December 2023 at 16H00.
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.
• Applications must be submitted by email to recruitment@sahpra.org.za, including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS.
• 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: 18 December 2023 at 16H00.
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.
• Applications must be submitted by email to recruitment@sahpra.org.za, including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS.
• 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: 18 December 2023 at 16H00.
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.
• Applications must be submitted by email to recruitment@sahpra.org.za, including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS.
• 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: 18 December 2023 at 16H00.
MEDICINES REGISTRATION OFFICER - PHARMACOVIGILANCE (FIXED TERM CONTRACT POSITION: 24 MONTHS)
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 070/2023
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.
EXPERIENCE: • A minimum of three (3) years of Pharmacovigilance experience of which 1 year must be Regulatory. • Training and experience 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 1 – 4-year Bachelor of Pharmacy Degree or / Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of five (5) years of experience in regulatory).
(Grade 2 - 4-year Bachelor of Pharmacy Degree 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).
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. * 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.
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.
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.
• Applications must be submitted by email to recruitment@sahpra.org.za, including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS.
• 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: 18 December 2023 at 16H00.
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.
EXPERIENCE: • A minimum of three (3) years of Pharmacovigilance experience of which 1 year must be Regulatory. • Training and experience 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 1 – 4-year Bachelor of Pharmacy Degree or / Honours Degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of five (5) years of experience in regulatory).
(Grade 2 - 4-year Bachelor of Pharmacy Degree 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).
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. * 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.
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.
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.
• Applications must be submitted by email to recruitment@sahpra.org.za, including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS.
• 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: 18 December 2023 at 16H00.