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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.
MEDICINES REGISTRATION OFFICER – CLINICAL POST REGISTRATION x 3
Ref No.: SAHPRA 046/2023
SALARY LEVEL 11: R788 910 to R837 326 per annum (Total cost to company)
CENTRE: Pretoria
REQUIREMENTS:
• Required qualifications: 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).
• Desired: A relevant Master’s qualification in the health sciences.
• A minimum of 6 years’ clinical experience.
• Regulatory experience of a least 1 year will be an added advantage.
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES:
Knowledge and application of the Medicines and Related Substances Control Act 101of 1965, as amended, and its related Regulations, with respect to the regulation of medicines in terms of quality, safety, and efficacy. * Knowledge and understanding of the legal and regulatory framework governing the review process, locally and internationally. * An understanding of the medicine’s discovery process and the pharmaceutical regulatory environment. * Technical proficiency in regulatory review practices, pharmacokinetics, pharmacodynamics, bioavailability/bioequivalence, clinical study data analysis and review for safety, efficacy, and quality. * Computer literacy (MS Office packages). * Supervisory skills. * Good planning, organizational and interpersonal skills. * Good communication skills (written and verbal). * Innovative thinking, initiative, and leadership qualities. * Dedication and accurate work. * Knowledge of database management will be advantageous. * Must be willing to travel and work irregular hours. * A valid driver’s license. * Ability to work well under pressure. * Collaborative skills. * Knowledge of quality management systems. * Organisational awareness. * Good decision-making and critical analytical skills.
DUTIES:
Assess, analyse, and provide recommendations for minor safety amendments (Type Iain and Type IB) applications, including the applicant’s responses to safety concerns raised by either the applicants or the Authority. Identify key issues, and critically evaluate scientific data (i.e., pharmacokinetic, bioavailability, and bioequivalence data, in vitro (pre-clinical) and in vivo clinical studies of a medicine with different endpoints) from multiple sources. Provide recommendations for major safety and/or efficacy amendments for simpler and complex molecules. Conducting a comprehensive review to ensure that the risk profile of each medicinal product is regularly updated to incorporate new information and that risk criteria are modified based on new statistical data on hazards, possible damages to manage their impact on clinical practice and public health. Review and summarise relevant information from clinical trials for product information documents to ensure that the product information contains accurate claims on product effectiveness, and safety as well as adequate directions for product use. Consult other experts, act as a mentor, and provide guidance on assessments to other reviewers by conducting a critical review of their reports. Ensure timeous reviews of applications.
Identifies the parts of a scientific publication and the general purpose of each part. Searches published literature using key terms to find articles on specific subjects related to the application undergoing review. Summarises the essential message and purpose of published materials, such as scientific publications, reports, or guidelines. Utilises the full range of reference and resource materials in this area.
Generate detailed scientific evaluation reports in line with the good review practice guide, ICH guidelines, SAHPRA guidelines and other relevant international standards for internal peer review and where necessary, for presentation to the Advisory Clinical Committee. Prepare evaluation outcome (recommendations/queries/approval/non-approval) to be communicated to the external stakeholder.
Ensure priority medicines and urgent applications/responses are screened and identified as such for rapid processing as per the priority review policy. Attend to queries from previous and/or current screening cycle. Ensure that the outcome is captured on the database and that a rejection/approval letter is sent out to the applicant. Conduct thorough technical screening of variation applications for evaluation i.e., ensuring references submitted to support the proposed amendments are appropriate and complete.
Assess submissions for compliance with the local regulatory requirements as stipulated in the variation addendum and other clinical guidelines. Direct the implementation of different regulatory pathways based on reliance, collaboration, and recognition. Prepare a screening outcome report and to be communicated to the external stakeholders.
Assess submissions for compliance with the Variation addendum and other clinical guidelines. Primary and peer review of responses with clinical data for simpler molecules. Prepare a critical clinical response evaluation report after the review of the safety and/or efficacy data from clinical studies, published literature sources, reliance decisions of other regulatory authorities, or review of documented signals. Prepare evaluation outcome (recommendations/queries/approval/non-approval) and communicate outcome to the applicant.
Ensure an unqualified risk and internal audit opinion for Clinical Post-Registrations by submitting monthly POEs and updating the risk register monthly. Continuously respond to the needs and expectations of the industry, external evaluators, and Internal queries within a period of 1 week. Adherence to SOPs and SAHPRA, ICH, EMA and other relevant guidelines. Develop, review, and improve the accuracy of databases to enable revenue recognition by the finance unit. Respond to relevant queries timeously. Attend relevant training as may be necessary.
Liaising with management, legal and communications departments for advice to clarify established SAHPRA systems and methodologies. Provides comments, inputs and advice on international standards and guidance documents, representing the interest of SAHPRA at national, regional, and international levels. Provides regulatory support and guidance to industry and other stakeholders of the Authority. Provides support to management in the operation of the department/unit. Participate in special projects and Pre- and Post-registration working groups as required and engage in technical scientific discussions on ongoing applications under review. Prepare discussion documents, including agendas, minutes and action items, and reports where required. Preparation of recommendations for pharmacovigilance referral outcome. Capturing and Execution of Advisory Clinical Committee recommendations. Participate in international scientific regulatory forums and discussion groups including ICH or WHO, as relevant and when nominated. Provide regular work-plans and output to the manager. Perform any other related duty as requested by the manager/senior manager.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names of 3 referees and recently certified copies of ID and qualification/s.
• Applications without the aforementioned 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 or faxed applications will be accepted. CV’s 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: Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: 19 September 2023 at 16H00.
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.
MEDICINES REGISTRATION OFFICER – CLINICAL POST REGISTRATION x 3
Ref No.: SAHPRA 046/2023
SALARY LEVEL 11: R788 910 to R837 326 per annum (Total cost to company)
CENTRE: Pretoria
REQUIREMENTS:
• Required qualifications: 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).
• Desired: A relevant Master’s qualification in the health sciences.
• A minimum of 6 years’ clinical experience.
• Regulatory experience of a least 1 year will be an added advantage.
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES:
Knowledge and application of the Medicines and Related Substances Control Act 101of 1965, as amended, and its related Regulations, with respect to the regulation of medicines in terms of quality, safety, and efficacy. * Knowledge and understanding of the legal and regulatory framework governing the review process, locally and internationally. * An understanding of the medicine’s discovery process and the pharmaceutical regulatory environment. * Technical proficiency in regulatory review practices, pharmacokinetics, pharmacodynamics, bioavailability/bioequivalence, clinical study data analysis and review for safety, efficacy, and quality. * Computer literacy (MS Office packages). * Supervisory skills. * Good planning, organizational and interpersonal skills. * Good communication skills (written and verbal). * Innovative thinking, initiative, and leadership qualities. * Dedication and accurate work. * Knowledge of database management will be advantageous. * Must be willing to travel and work irregular hours. * A valid driver’s license. * Ability to work well under pressure. * Collaborative skills. * Knowledge of quality management systems. * Organisational awareness. * Good decision-making and critical analytical skills.
DUTIES:
Assess, analyse, and provide recommendations for minor safety amendments (Type Iain and Type IB) applications, including the applicant’s responses to safety concerns raised by either the applicants or the Authority. Identify key issues, and critically evaluate scientific data (i.e., pharmacokinetic, bioavailability, and bioequivalence data, in vitro (pre-clinical) and in vivo clinical studies of a medicine with different endpoints) from multiple sources. Provide recommendations for major safety and/or efficacy amendments for simpler and complex molecules. Conducting a comprehensive review to ensure that the risk profile of each medicinal product is regularly updated to incorporate new information and that risk criteria are modified based on new statistical data on hazards, possible damages to manage their impact on clinical practice and public health. Review and summarise relevant information from clinical trials for product information documents to ensure that the product information contains accurate claims on product effectiveness, and safety as well as adequate directions for product use. Consult other experts, act as a mentor, and provide guidance on assessments to other reviewers by conducting a critical review of their reports. Ensure timeous reviews of applications.
Identifies the parts of a scientific publication and the general purpose of each part. Searches published literature using key terms to find articles on specific subjects related to the application undergoing review. Summarises the essential message and purpose of published materials, such as scientific publications, reports, or guidelines. Utilises the full range of reference and resource materials in this area.
Generate detailed scientific evaluation reports in line with the good review practice guide, ICH guidelines, SAHPRA guidelines and other relevant international standards for internal peer review and where necessary, for presentation to the Advisory Clinical Committee. Prepare evaluation outcome (recommendations/queries/approval/non-approval) to be communicated to the external stakeholder.
Ensure priority medicines and urgent applications/responses are screened and identified as such for rapid processing as per the priority review policy. Attend to queries from previous and/or current screening cycle. Ensure that the outcome is captured on the database and that a rejection/approval letter is sent out to the applicant. Conduct thorough technical screening of variation applications for evaluation i.e., ensuring references submitted to support the proposed amendments are appropriate and complete.
Assess submissions for compliance with the local regulatory requirements as stipulated in the variation addendum and other clinical guidelines. Direct the implementation of different regulatory pathways based on reliance, collaboration, and recognition. Prepare a screening outcome report and to be communicated to the external stakeholders.
Assess submissions for compliance with the Variation addendum and other clinical guidelines. Primary and peer review of responses with clinical data for simpler molecules. Prepare a critical clinical response evaluation report after the review of the safety and/or efficacy data from clinical studies, published literature sources, reliance decisions of other regulatory authorities, or review of documented signals. Prepare evaluation outcome (recommendations/queries/approval/non-approval) and communicate outcome to the applicant.
Ensure an unqualified risk and internal audit opinion for Clinical Post-Registrations by submitting monthly POEs and updating the risk register monthly. Continuously respond to the needs and expectations of the industry, external evaluators, and Internal queries within a period of 1 week. Adherence to SOPs and SAHPRA, ICH, EMA and other relevant guidelines. Develop, review, and improve the accuracy of databases to enable revenue recognition by the finance unit. Respond to relevant queries timeously. Attend relevant training as may be necessary.
Liaising with management, legal and communications departments for advice to clarify established SAHPRA systems and methodologies. Provides comments, inputs and advice on international standards and guidance documents, representing the interest of SAHPRA at national, regional, and international levels. Provides regulatory support and guidance to industry and other stakeholders of the Authority. Provides support to management in the operation of the department/unit. Participate in special projects and Pre- and Post-registration working groups as required and engage in technical scientific discussions on ongoing applications under review. Prepare discussion documents, including agendas, minutes and action items, and reports where required. Preparation of recommendations for pharmacovigilance referral outcome. Capturing and Execution of Advisory Clinical Committee recommendations. Participate in international scientific regulatory forums and discussion groups including ICH or WHO, as relevant and when nominated. Provide regular work-plans and output to the manager. Perform any other related duty as requested by the manager/senior manager.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names of 3 referees and recently certified copies of ID and qualification/s.
• Applications without the aforementioned 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 or faxed applications will be accepted. CV’s 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: Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: 19 September 2023 at 16H00.
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 – NAMES AND SCHEDULING
Ref No.: SAHPRA 047/2023
SALARY LEVEL 11: R788 910 to R837 326 per annum (Total cost to company)
CENTRE: Pretoria
REQUIREMENTS:
• Appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC).
• Pharmacist with a minimum of 8 years’ appropriate experience.
• A relevant NQF 9 qualification in the health sciences will be an added advantage.
• Knowledge of technical evaluation of safety and efficacy aspects of medicines.
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES:
Knowledge and application of the Medicines and Related Substances Control Act (101 of 1965),as amended, and its related Regulations, with respect to the regulation of medicines in terms of quality, safety, and efficacy. * Knowledge of technical aspects for evaluation of quality and efficacy of bioequivalence of medicines. * Comprehensive knowledge and understanding of relevant legislation, guidelines, protocols, standard operating procedures, and work instructions as outlined by regulatory authorities. * Good planning, organizational and interpersonal skills. * Initiative-taking and able to work independently. * Good communication skills (written, verbal, negotiation, conflict management, presentation). * Innovative thinking, initiative, assertive and leadership qualities. * Dedication and accurate work. * Ethical behavior. * Must be willing to travel and work irregular hours. * Customer service. * Planning and organizing skills.
DUTIES:
Generate evaluation report(s) for each new applications (Generics) in compliance with required template and adopted regulatory /scientific standards and submit for peer review.
Following peer review process amend the report (s) accordingly to generate a list of queries to the applicant using the correct templates. Prepare report for the internal working groups and where necessary present at advisory committee for complex scientific matters. Provide quality assurance of reports and facilitate resolutions on technical matters. Generate evaluation report(s) for each new applications (Generics) in compliance with required template and adopted regulatory /scientific standards and submit for peer review. Following peer review process amend the report (s) accordingly to generate a list of queries to the applicant using the correct templates. Prepare report for the internal working groups and where necessary present at advisory committee for complex scientific matters. Provide quality assurance of reports and facilitate resolutions on technical matters.
Generate second (and subsequent) evaluation report (s) for each response application and submit for peer review in compliance with required template and adopted regulatory /scientific standards and submit for peer review. Peer review other evaluators response reports, according to the required template and adopted regulatory/scientific standards. Prepare report for the internal working groups and where necessary present at advisory committee for complex scientific matters. Prepare query letter to the applicant. Provide quality assurance of reports and facilitate resolutions on technical matters. Participate in special projects and registration group. Lead and manage assessments peer review and discussion working group where relevant. Compile discussion documents and reports. Provide regular trainings to new internal MRO’s and external evaluators. Take comprehensive notes of discussions of relevant discussions. Prepare documents for SAHPRA management/ RC meeting.
Review existing guidelines, SOPs and templates and update when necessary. Provide training on guidelines, SOPs, and templates. Create new guidelines, SOPs, and templates where SOPs aren’t in place. Provide regular work-plans and output to the unit manager (qualitative and quantities report). Perform any other related duty as requested by manager/senior manager. Attend and support the internal and external Audit, including resolution of queries. Manage and keep records regularly of clinical trial related activities. Investigate and advise pharmaceutical industry / applicant’s queries or other members of the Public. Manage resolution of the queries in area of work. Provide advice or recommend to inspectorate or regulatory compliance unit. Represent SAHPRA in the local, regional and/or global sphere. Arrange and attend Industry Task Group working groups and external stakeholder meetings. Review the request from the applicant and prepare a report/document for Advisory Naming and Scheduling Committee. Capture the final recommendation from the Advisory Naming and Scheduling Committee. Prepare a referral letter to Advisory Clinical Committee or any other relevant advisory committee. Consolidate the reports and submit to registration committee’s approval/rejection. Liaise with relevant stakeholder on the outcome of the request. Prepare a submission to Minister of Health for approval of amendments on consolidated schedule.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names of 3 referees and recently certified copies of ID and qualification/s.
• Applications without the aforementioned 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 or faxed applications will be accepted. CV’s 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: Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: 19 September 2023 at 16H00.
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 – NAMES AND SCHEDULING
Ref No.: SAHPRA 047/2023
SALARY LEVEL 11: R788 910 to R837 326 per annum (Total cost to company)
CENTRE: Pretoria
REQUIREMENTS:
• Appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC).
• Pharmacist with a minimum of 8 years’ appropriate experience.
• A relevant NQF 9 qualification in the health sciences will be an added advantage.
• Knowledge of technical evaluation of safety and efficacy aspects of medicines.
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES:
Knowledge and application of the Medicines and Related Substances Control Act (101 of 1965),as amended, and its related Regulations, with respect to the regulation of medicines in terms of quality, safety, and efficacy. * Knowledge of technical aspects for evaluation of quality and efficacy of bioequivalence of medicines. * Comprehensive knowledge and understanding of relevant legislation, guidelines, protocols, standard operating procedures, and work instructions as outlined by regulatory authorities. * Good planning, organizational and interpersonal skills. * Initiative-taking and able to work independently. * Good communication skills (written, verbal, negotiation, conflict management, presentation). * Innovative thinking, initiative, assertive and leadership qualities. * Dedication and accurate work. * Ethical behavior. * Must be willing to travel and work irregular hours. * Customer service. * Planning and organizing skills.
DUTIES:
Generate evaluation report(s) for each new applications (Generics) in compliance with required template and adopted regulatory /scientific standards and submit for peer review.
Following peer review process amend the report (s) accordingly to generate a list of queries to the applicant using the correct templates. Prepare report for the internal working groups and where necessary present at advisory committee for complex scientific matters. Provide quality assurance of reports and facilitate resolutions on technical matters. Generate evaluation report(s) for each new applications (Generics) in compliance with required template and adopted regulatory /scientific standards and submit for peer review. Following peer review process amend the report (s) accordingly to generate a list of queries to the applicant using the correct templates. Prepare report for the internal working groups and where necessary present at advisory committee for complex scientific matters. Provide quality assurance of reports and facilitate resolutions on technical matters.
Generate second (and subsequent) evaluation report (s) for each response application and submit for peer review in compliance with required template and adopted regulatory /scientific standards and submit for peer review. Peer review other evaluators response reports, according to the required template and adopted regulatory/scientific standards. Prepare report for the internal working groups and where necessary present at advisory committee for complex scientific matters. Prepare query letter to the applicant. Provide quality assurance of reports and facilitate resolutions on technical matters. Participate in special projects and registration group. Lead and manage assessments peer review and discussion working group where relevant. Compile discussion documents and reports. Provide regular trainings to new internal MRO’s and external evaluators. Take comprehensive notes of discussions of relevant discussions. Prepare documents for SAHPRA management/ RC meeting.
Review existing guidelines, SOPs and templates and update when necessary. Provide training on guidelines, SOPs, and templates. Create new guidelines, SOPs, and templates where SOPs aren’t in place. Provide regular work-plans and output to the unit manager (qualitative and quantities report). Perform any other related duty as requested by manager/senior manager. Attend and support the internal and external Audit, including resolution of queries. Manage and keep records regularly of clinical trial related activities. Investigate and advise pharmaceutical industry / applicant’s queries or other members of the Public. Manage resolution of the queries in area of work. Provide advice or recommend to inspectorate or regulatory compliance unit. Represent SAHPRA in the local, regional and/or global sphere. Arrange and attend Industry Task Group working groups and external stakeholder meetings. Review the request from the applicant and prepare a report/document for Advisory Naming and Scheduling Committee. Capture the final recommendation from the Advisory Naming and Scheduling Committee. Prepare a referral letter to Advisory Clinical Committee or any other relevant advisory committee. Consolidate the reports and submit to registration committee’s approval/rejection. Liaise with relevant stakeholder on the outcome of the request. Prepare a submission to Minister of Health for approval of amendments on consolidated schedule.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names of 3 referees and recently certified copies of ID and qualification/s.
• Applications without the aforementioned 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 or faxed applications will be accepted. CV’s 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: Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: 19 September 2023 at 16H00.
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.
TECHNICAL OFFICER: MEDICAL DEVICES CLINICAL TRIALS
SALARY: R788 910.00 – R837 326.00 (TOTAL COST TO COMPANY)
Ref No.: SAHPRA 042/2023
CENTRE: Pretoria
REQUIREMENTS: • Four year Natural / Medical Sciences / Clinical Engineering / Pharmacy Degree (Proof of registration with the SAPC as a Pharmacist for B-Pharm degree). • Relevant post graduate qualification will be an advantage. • Training in: * Regulation and/or registration of medical devices. * Assessment of quality, safety, performance of medical devices.
EXPERIENCE: • A minimum of 3 years relevant experience in: * Regulation and/or clinical trials of medical devices. * Assessment of quality, safety, performance of medical devices * Development and maintenance of standard operating procedures and technical guidelines. * Ability to perform teamwork. * Scientific report writing.
REQUIRED 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:
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: 15 September 2023 at 16H00.
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.
TECHNICAL OFFICER: MEDICAL DEVICES CLINICAL TRIALS
SALARY: R788 910.00 – R837 326.00 (TOTAL COST TO COMPANY)
Ref No.: SAHPRA 042/2023
CENTRE: Pretoria
REQUIREMENTS: • Four year Natural / Medical Sciences / Clinical Engineering / Pharmacy Degree (Proof of registration with the SAPC as a Pharmacist for B-Pharm degree). • Relevant post graduate qualification will be an advantage. • Training in: * Regulation and/or registration of medical devices. * Assessment of quality, safety, performance of medical devices.
EXPERIENCE: • A minimum of 3 years relevant experience in: * Regulation and/or clinical trials of medical devices. * Assessment of quality, safety, performance of medical devices * Development and maintenance of standard operating procedures and technical guidelines. * Ability to perform teamwork. * Scientific report writing.
REQUIRED 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: 15 September 2023 at 16H00.
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.
TECHNICAL OFFICER: MEDICAL DEVICES REGISTRATION
SALARY: R788 910.00 – R837 326.00 (TOTAL COST TO COMPANY)
Ref No.: SAHPRA 039/2023
CENTRE: Pretoria
REQUIREMENTS: • Four year Natural / Medical Sciences / Clinical engineering / Pharmacy Degree (Proof of registration with the SAPC as a Pharmacist for B-Pharm degree). • Relevant post graduate qualification will be an advantage. • Training in: * Regulation and/or registration of medical devices. * Assessment of quality, safety, performance of medical devices.
EXPERIENCE: • A minimum of 3 years relevant experience in: * Regulation and/or registration of medical devices. * Assessment of quality, safety, performance of medical devices * Development and maintenance of standard operating procedures and technical guidelines. * Teamwork. * Scientific report writing.
REQUIRED 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 registration (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).
- Evaluate and manage applications for registration 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.
- 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).
- Liaise with international regulatory authorities.
- Interview members from industry to discuss SAHPRA Board resolutions, requirements of the Act and medical device and IVD quality 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: 15 September 2023 at 16H00.