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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.
EXECUTIVE ASSISTANT TO THE CEO
SALARY: R 623 692.00 – R 661 941.00 PER ANNUM (TOTAL COST TO COMPANY)
Ref No.: SAHPRA 01/2025
CENTRE: PRETORIA
REQUIREMENTS: A Matric Certificate plus National Diploma, (NQF level 6) as recognised by SAQA in Office Management and Technology; Office Administration and Management / Business Administration / Public Administration /Public Management or a relevant equivalent qualification. A Bachelor’s degree (NQF level 7) in a related field will be an added advantage.
A minimum of six (6) year’s as Senior Secretarial / Assistant or Administration experience. Three (3) years of experience as Personal Assistant or Executive Assistant to Senior / Executive Manager in a regulatory environment will be an added advantage.
Strong proficiency in Microsoft Office Suite packages and an ability to work with data. Regulatory environmental experience will be an added advantage. Valid driver’s licence is essential.
COMPETENCIES, KNOWLEDGE, AND SKILLS: Excellent administrative skills, including identifying administrative needs and developing and maintaining appropriate systems * Critical thinking and the ability to exercise good judgment and solve problems quickly and effectively * Excellent organizational and planning skills that ensure that work is effectively prioritized to meet deadlines * Ability to maintain high levels of confidentiality * Ability to maintain accuracy and attention to detail. * Ability to work under pressure * Strong command of written and verbal communication skills * Excellent interpersonal & intrapersonal skills * Report Writing plus basic research skills * Client Orientation and Customer focus * Deadline driven * An ability to coordinate plan and manage a complex and busy diary * Ability to draft routine correspondence and reports * Proven track record in building and managing stakeholder relationships at all levels.
DUTIES: Developing and implementing an effective office administration system for the office of the CEO * Provide administrative support to the CEO to ensure the CEO’s schedule is managed effectively * Provide comprehensive support services to the CEO that ensure outstanding communication and responsiveness * Provide calendar management; prioritize inquiries and requests, troubleshoot conflicts with little guidance, and make judgments and recommendations to ensure smooth day-to-day engagements * Ensure presentations, speeches, biographies, briefing notes etc are drafted or provided timeously for meetings, workshops and conferences * Type letters /Memos or review documents as per Executive request, and follow up on actions/decisions from the CEO to Management * Prepare and edit correspondence, presentations, reports, and other communication. Manage all scheduling and travel logistics for the CEO * Continually monitor the flow of information going in and out of the CEO’s office * Compiling of meeting documents and agendas for the meeting * Manage the diary and schedule meetings and appointments on behalf of the CEO * Arranging catering with all kinds of dietary requirements and ensuring that all relevant packs/stationery for the workshop are available, and that the venues meet all operational requirements * Processing of subsistence and travelling claims * Manage the office petty cash and procurement of goods and services and manage the office resources * Oversee the reconciliation of claims by the CEO and/or Office Manager * Planning and Coordinate functions, events and operational projects * Attend relevant internal and external meetings as per request by the CEO and/or Office Manager.
INSTRUCTIONS TO APPLICANTS: (HOW TO APPLY): Interested applicants who meet the above requirements should forward their applications accompanied by signed covering letter attached to the comprehensive CV with the names and email addresses of three (3) referees clearly reflecting the name of the position and post reference number, and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
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. All shortlisted candidates will be subjected to a technical exercise that intends to test relevant knowledge, skill and technical elements of the job. 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.
Interested persons who meet the above-stated qualifications should forward their applications which should consist of a cover letter, detailed Curriculum Vitae, copies of qualification(s) and Identity Document. ONLY shortlisted candidates will be required to submit certified copies of qualifications and other related documents on or before the day of the interview following communication from Human Resources.
SAHPRA comply with the provisions of Protection of Personal Information Act (POPIA); Act No. 4 of 2013. We will use your personal information provided to us for the purpose of recruitment only and more specifically for the purpose of the position/vacancy you have applied for. In the event your application was unsuccessful, SAHPRA will retain your personal information for internal audit purposes as required by policies.
Applications should be submitted through the SAHPRA Website Online Portal: SAHPRA website(https://www.sahpra.org.za) – About Us – Vacancies.
Enquiries: Technical related enquiries: Ms M Mphidi Email: Mukona.Mphidi@sahpra.org.za
HR related enquiries: Mr T Khunou, Email: Tshepo.Khunou@sahpra.org.za
(APPLICATIONS SENT TO THESE EMAIL ADDRESSES WILL NOT BE CONSIDERED FOR THE RECRUITMENT PROCESS). The closing date is 20 January 2025 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.
EXECUTIVE ASSISTANT TO THE CEO
SALARY: R 623 692.00 – R 661 941.00 PER ANNUM (TOTAL COST TO COMPANY)
Ref No.: SAHPRA 01/2025
CENTRE: PRETORIA
REQUIREMENTS: A Matric Certificate plus National Diploma, (NQF level 6) as recognised by SAQA in Office Management and Technology; Office Administration and Management / Business Administration / Public Administration /Public Management or a relevant equivalent qualification. A Bachelor’s degree (NQF level 7) in a related field will be an added advantage.
A minimum of six (6) year’s as Senior Secretarial / Assistant or Administration experience. Three (3) years of experience as Personal Assistant or Executive Assistant to Senior / Executive Manager in a regulatory environment will be an added advantage.
Strong proficiency in Microsoft Office Suite packages and an ability to work with data. Regulatory environmental experience will be an added advantage. Valid driver’s licence is essential.
COMPETENCIES, KNOWLEDGE, AND SKILLS: Excellent administrative skills, including identifying administrative needs and developing and maintaining appropriate systems * Critical thinking and the ability to exercise good judgment and solve problems quickly and effectively * Excellent organizational and planning skills that ensure that work is effectively prioritized to meet deadlines * Ability to maintain high levels of confidentiality * Ability to maintain accuracy and attention to detail. * Ability to work under pressure * Strong command of written and verbal communication skills * Excellent interpersonal & intrapersonal skills * Report Writing plus basic research skills * Client Orientation and Customer focus * Deadline driven * An ability to coordinate plan and manage a complex and busy diary * Ability to draft routine correspondence and reports * Proven track record in building and managing stakeholder relationships at all levels.
DUTIES: Developing and implementing an effective office administration system for the office of the CEO * Provide administrative support to the CEO to ensure the CEO’s schedule is managed effectively * Provide comprehensive support services to the CEO that ensure outstanding communication and responsiveness * Provide calendar management; prioritize inquiries and requests, troubleshoot conflicts with little guidance, and make judgments and recommendations to ensure smooth day-to-day engagements * Ensure presentations, speeches, biographies, briefing notes etc are drafted or provided timeously for meetings, workshops and conferences * Type letters /Memos or review documents as per Executive request, and follow up on actions/decisions from the CEO to Management * Prepare and edit correspondence, presentations, reports, and other communication. Manage all scheduling and travel logistics for the CEO * Continually monitor the flow of information going in and out of the CEO’s office * Compiling of meeting documents and agendas for the meeting * Manage the diary and schedule meetings and appointments on behalf of the CEO * Arranging catering with all kinds of dietary requirements and ensuring that all relevant packs/stationery for the workshop are available, and that the venues meet all operational requirements * Processing of subsistence and travelling claims * Manage the office petty cash and procurement of goods and services and manage the office resources * Oversee the reconciliation of claims by the CEO and/or Office Manager * Planning and Coordinate functions, events and operational projects * Attend relevant internal and external meetings as per request by the CEO and/or Office Manager.
INSTRUCTIONS TO APPLICANTS: (HOW TO APPLY): Interested applicants who meet the above requirements should forward their applications accompanied by signed covering letter attached to the comprehensive CV with the names and email addresses of three (3) referees clearly reflecting the name of the position and post reference number, and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
- Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
- A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
- No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered.
- Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within three (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. All shortlisted candidates will be subjected to a technical exercise that intends to test relevant knowledge, skill and technical elements of the job. 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.
Interested persons who meet the above-stated qualifications should forward their applications which should consist of a cover letter, detailed Curriculum Vitae, copies of qualification(s) and Identity Document. ONLY shortlisted candidates will be required to submit certified copies of qualifications and other related documents on or before the day of the interview following communication from Human Resources.
SAHPRA comply with the provisions of Protection of Personal Information Act (POPIA); Act No. 4 of 2013. We will use your personal information provided to us for the purpose of recruitment only and more specifically for the purpose of the position/vacancy you have applied for. In the event your application was unsuccessful, SAHPRA will retain your personal information for internal audit purposes as required by policies.
Applications should be submitted through the SAHPRA Website Online Portal: SAHPRA website(https://www.sahpra.org.za) – About Us – Vacancies.
Enquiries: Technical related enquiries: Ms M Mphidi Email: Mukona.Mphidi@sahpra.org.za
HR related enquiries: Mr T Khunou, Email: Tshepo.Khunou@sahpra.org.za
(APPLICATIONS SENT TO THESE EMAIL ADDRESSES WILL NOT BE CONSIDERED FOR THE RECRUITMENT PROCESS). The closing date is 20 January 2025 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.
This procurement will be managed by Supporting Health Initiatives (SHI), a Division of Wits Health Consortium Pty Ltd (WHC) for and on behalf of SAHPRA. SHI is dedicated to promoting and enabling public health activities that lead to new, significant advancements in healthcare and related fields and does this by providing resources, collaborative opportunities and project management support to partners and funders. SHI has developed a strong track record of delivering on assignments in Africa. SHI’s operations and business teams have demonstrated capacity to quickly align with partners, distribute funds, and oversee implementation.
SPECIALIST: GOOD MANUFACTURING PRACTICES (GMP)
Contract: Ending 31 December 2026, with possible extension based on performance.
Location: Pretoria, South Africa (Hybrid) (South Africans encouraged to apply).
Reference: SAHPRA 033/2024 Remuneration: Competitive, depending on experience.
Why Join Us?
This is a unique opportunity for international subject matter experts to work in a hybrid model, collaborating with SAHPRA to advance Good Manufacturing Practices (GMP) within South Africa and beyond. This position offers an unparalleled chance to make a global impact, work alongside leading professionals, and contribute to the regulatory excellence that safeguards public health worldwide.
Key Responsibilities include but are not limited to:
• Conduct GMP Inspections: Lead local and international pharmaceutical manufacturing site inspections, ensuring compliance with GMP standards adopted by SAHPRA.
• Policy Development and Advisory: Shape GMP-related policies, guidelines, and inspection frameworks in line with global best practices.
• Global Engagement: Collaborate with international regulatory bodies and represent SAHPRA in global regulatory forums and conferences.
• Capacity Building: Provide training, mentorship, and capacity development on GMP regulatory practices for SAHPRA staff and stakeholders.
• Risk Management: Ensure ethical, accurate, and efficient management of inspection-related risks, resources, and records.
Performance Expectation include but are not limited to:
• Demonstrate strong leadership qualities in a regulatory environment.
• Excellent communication, analytical, and decision-making skills to navigate complex challenges.
• Implement effective risk management strategies to mitigate potential risks and ensure the quality and safety of pharmaceutical products.
• Thrive in a dynamic and multicultural environment while working effectively within diverse teams.
• Adapt and manage competing priorities efficiently.
• Conduct thorough inspections of local and international pharmaceutical manufacturing sites to verify adherence to SAHPRA's GMP standards.
• Consistently identify and document GMP deviations and compliance issues, and issue inspection reports that are accurate, timely, and well-supported by evidence.
• Play a key role in developing and implementing GMP-related policies, guidelines, and inspection frameworks.
• Transfer skill to SAHPRA staff and stakeholders on GMP regulations and inspection procedures.
• Contribute to capacity development initiatives to enhance GMP expertise within the organization.
• Adhere to South African data protection laws and SAHPRA's specific data protection policies
Application Criteria:
Qualifications and Expertise
• Essential:
• Preferred:
Core Competencies
• Deep knowledge of GMP legislation, regulations, and international protocols.
• Advanced analytical, communication, and decision-making skills for complex regulatory challenges.
• Proven ability to lead, mentor, and work within diverse teams in high-pressure environments.
• Adaptability and resilience to manage competing priorities effectively.
What We Offer
• Hybrid Working Model: Flexibility to work remotely with periodic travel to South Africa, supported by robust digital tools.
• Global Impact: Contribute to shaping GMP standards and advancing public health on a global scale.
• Professional Growth: Collaborate with leading regulatory professionals and institutions in a dynamic, multicultural environment.
• Innovative Collaboration: Join a team committed to regulatory excellence and transformative public health initiatives.
Application Process
Submit your application via email to SHIproposals@supportinghi.co.za, by c.o.b 17 January 2025.
Applications must include:
• A detailed cover letter and curriculum vitae.
• Certified copies of qualifications, including professional registrations.
• A copy of a valid driver's license.
Please note: Applications must clearly state the position and reference number. Late or incomplete submissions will not be considered.
Diversity and Inclusion: SAHPRA is an equal opportunity employer committed to fostering diversity in its workforce. Candidates from underrepresented groups and individuals with disabilities are encouraged to apply.
For inquiries: contact Mr Itumeleng Mosenyi at Itumeleng. Mosenyi@sahpra.org.za. (Note: Applications sent to this email will not be processed).
Only shortlisted candidates will be contacted.
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.
This procurement will be managed by Supporting Health Initiatives (SHI), a Division of Wits Health Consortium Pty Ltd (WHC) for and on behalf of SAHPRA. SHI is dedicated to promoting and enabling public health activities that lead to new, significant advancements in healthcare and related fields and does this by providing resources, collaborative opportunities and project management support to partners and funders. SHI has developed a strong track record of delivering on assignments in Africa. SHI’s operations and business teams have demonstrated capacity to quickly align with partners, distribute funds, and oversee implementation.
SPECIALIST: GOOD MANUFACTURING PRACTICES (GMP)
Contract: Ending 31 December 2026, with possible extension based on performance.
Location: Pretoria, South Africa (Hybrid) (South Africans encouraged to apply).
Reference: SAHPRA 033/2024 Remuneration: Competitive, depending on experience.
Why Join Us?
This is a unique opportunity for international subject matter experts to work in a hybrid model, collaborating with SAHPRA to advance Good Manufacturing Practices (GMP) within South Africa and beyond. This position offers an unparalleled chance to make a global impact, work alongside leading professionals, and contribute to the regulatory excellence that safeguards public health worldwide.
Key Responsibilities include but are not limited to:
• Conduct GMP Inspections: Lead local and international pharmaceutical manufacturing site inspections, ensuring compliance with GMP standards adopted by SAHPRA.
• Policy Development and Advisory: Shape GMP-related policies, guidelines, and inspection frameworks in line with global best practices.
• Global Engagement: Collaborate with international regulatory bodies and represent SAHPRA in global regulatory forums and conferences.
• Capacity Building: Provide training, mentorship, and capacity development on GMP regulatory practices for SAHPRA staff and stakeholders.
• Risk Management: Ensure ethical, accurate, and efficient management of inspection-related risks, resources, and records.
Performance Expectation include but are not limited to:
• Demonstrate strong leadership qualities in a regulatory environment.
• Excellent communication, analytical, and decision-making skills to navigate complex challenges.
• Implement effective risk management strategies to mitigate potential risks and ensure the quality and safety of pharmaceutical products.
• Thrive in a dynamic and multicultural environment while working effectively within diverse teams.
• Adapt and manage competing priorities efficiently.
• Conduct thorough inspections of local and international pharmaceutical manufacturing sites to verify adherence to SAHPRA's GMP standards.
• Consistently identify and document GMP deviations and compliance issues, and issue inspection reports that are accurate, timely, and well-supported by evidence.
• Play a key role in developing and implementing GMP-related policies, guidelines, and inspection frameworks.
• Transfer skill to SAHPRA staff and stakeholders on GMP regulations and inspection procedures.
• Contribute to capacity development initiatives to enhance GMP expertise within the organization.
• Adhere to South African data protection laws and SAHPRA's specific data protection policies
Application Criteria:
Qualifications and Expertise
• Essential:
- Master’s degree in Pharmacy.
- Registration as a Pharmacist.
- A minimum of 10 years of experience in pharmaceutical manufacturing or quality management systems (QMS), including GMP inspections.
- Proven technical leadership in regulatory environments and participation in international regulatory forums or advisory bodies.
• Preferred:
- A PhD in a related field.
- Demonstrated experience with hybrid or remote international collaboration.
Core Competencies
• Deep knowledge of GMP legislation, regulations, and international protocols.
• Advanced analytical, communication, and decision-making skills for complex regulatory challenges.
• Proven ability to lead, mentor, and work within diverse teams in high-pressure environments.
• Adaptability and resilience to manage competing priorities effectively.
What We Offer
• Hybrid Working Model: Flexibility to work remotely with periodic travel to South Africa, supported by robust digital tools.
• Global Impact: Contribute to shaping GMP standards and advancing public health on a global scale.
• Professional Growth: Collaborate with leading regulatory professionals and institutions in a dynamic, multicultural environment.
• Innovative Collaboration: Join a team committed to regulatory excellence and transformative public health initiatives.
Application Process
Submit your application via email to SHIproposals@supportinghi.co.za, by c.o.b 17 January 2025.
Applications must include:
• A detailed cover letter and curriculum vitae.
• Certified copies of qualifications, including professional registrations.
• A copy of a valid driver's license.
Please note: Applications must clearly state the position and reference number. Late or incomplete submissions will not be considered.
Diversity and Inclusion: SAHPRA is an equal opportunity employer committed to fostering diversity in its workforce. Candidates from underrepresented groups and individuals with disabilities are encouraged to apply.
For inquiries: contact Mr Itumeleng Mosenyi at Itumeleng. Mosenyi@sahpra.org.za. (Note: Applications sent to this email will not be processed).
Only shortlisted candidates will be contacted.
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: CLINICAL PRE-REGISTRATION EVALUATIONS
SALARY: (R 700 105.00 – R 888 422.00) per annum (TOTAL COST TO COMPANY)
(Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification, Internship and Community Service in line with governing frameworks.
Ref No.: SAHPRA 038/2024
CENTRE: PRETORIA
REQUIREMENTS: Matric certificate and appropriate 4-year Degree in Pharmacy or related qualification at NQF level 8 as recognised by SAQA and registration with a Professional Body. A relevant Master’s Degree will be an added advantage. A valid driver’s license.
EXPERIENCE:
Grade 1 – A minimum of two (2) years of clinical experience post Internship and Community Service. Regulatory experience will be an added advantage.
Grade 2 – A minimum of five (5) years of clinical experience post Internship and Community Service of which two (2) years should be within regulatory experience.
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 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. 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: Evaluation of new applications and peer-reviewing of new applications: 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. *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 for registration/approval of medicines: *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. *Prepare a basis of approval or rejection. *Provide quality assurance of reports and facilitate resolutions on technical matters. Technical screening for the quality and efficacy (bioequivalence) aspects of new applications for the registration of medicines: *Generate technical screening evaluation report(s) for each application. *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 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. Form part of technical working groups or special projects and provide support to the unit as well as to the Advisory Committees: 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. Audit and Risk Management: *SOP’s and Guidelines must be adhered to. *Create and maintain data bases. *Use the most current templates and guidelines. *Provide and attend relevant training as may be necessary. *Align with QMS requirements. *Align with ICH, WHO and international standards.
INSTRUCTIONS TO APPLICANTS: (HOW TO APPLY): Interested applicants who meet the above requirements should forward their applications accompanied by signed covering letter attached to the comprehensive CV with the names and email addresses of three (3) referees clearly reflecting the name of the position and post reference number, and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
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. All shortlisted candidates will be subjected to a technical exercise that intends to test relevant knowledge, skill and technical elements of the job. 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.
Interested persons who meet the above-stated qualifications should forward their applications which should consist of a cover letter, detailed Curriculum Vitae, copies of qualification(s) and
Identity Document. ONLY shortlisted candidates will be required to submit certified copies of qualifications and other related documents on or before the day of the interview following communication from Human Resources.
SAHPRA comply with the provisions of Protection of Personal Information Act (POPIA); Act No. 4 of 2013. We will use your personal information provided to us for the purpose of recruitment only and more specifically for the purpose of the position/vacancy you have applied for. In the event your application was unsuccessful, SAHPRA will retain your personal information for internal audit purposes as required by policies.
Applications should be submitted through the SAHPRA Website Online Portal: SAHPRA website(https://www.sahpra.org.za) – About Us – Vacancies.
Enquiries: Technical related enquiries: Ms M Moropa, Email: mahlodi.moropa@sahpra.org.za
HR related enquiries: Ms B. Rakgotho, Email: bafedile.rakgotho@sahpra.org.za
(APPLICATIONS SENT TO THESE EMAIL ADDRESSES WILL NOT BE CONSIDERED FOR THE RECRUITMENT PROCESS). The closing date is 17 January 2025 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: CLINICAL PRE-REGISTRATION EVALUATIONS
SALARY: (R 700 105.00 – R 888 422.00) per annum (TOTAL COST TO COMPANY)
(Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification, Internship and Community Service in line with governing frameworks.
Ref No.: SAHPRA 038/2024
CENTRE: PRETORIA
REQUIREMENTS: Matric certificate and appropriate 4-year Degree in Pharmacy or related qualification at NQF level 8 as recognised by SAQA and registration with a Professional Body. A relevant Master’s Degree will be an added advantage. A valid driver’s license.
EXPERIENCE:
Grade 1 – A minimum of two (2) years of clinical experience post Internship and Community Service. Regulatory experience will be an added advantage.
Grade 2 – A minimum of five (5) years of clinical experience post Internship and Community Service of which two (2) years should be within regulatory experience.
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 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. 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: Evaluation of new applications and peer-reviewing of new applications: 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. *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 for registration/approval of medicines: *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. *Prepare a basis of approval or rejection. *Provide quality assurance of reports and facilitate resolutions on technical matters. Technical screening for the quality and efficacy (bioequivalence) aspects of new applications for the registration of medicines: *Generate technical screening evaluation report(s) for each application. *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 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. Form part of technical working groups or special projects and provide support to the unit as well as to the Advisory Committees: 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. Audit and Risk Management: *SOP’s and Guidelines must be adhered to. *Create and maintain data bases. *Use the most current templates and guidelines. *Provide and attend relevant training as may be necessary. *Align with QMS requirements. *Align with ICH, WHO and international standards.
INSTRUCTIONS TO APPLICANTS: (HOW TO APPLY): Interested applicants who meet the above requirements should forward their applications accompanied by signed covering letter attached to the comprehensive CV with the names and email addresses of three (3) referees clearly reflecting the name of the position and post reference number, and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
- Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
- A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
- No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered.
- Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
- It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment. All shortlisted candidates will be subjected to a technical exercise that intends to test relevant knowledge, skill and technical elements of the job. 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.
Interested persons who meet the above-stated qualifications should forward their applications which should consist of a cover letter, detailed Curriculum Vitae, copies of qualification(s) and
Identity Document. ONLY shortlisted candidates will be required to submit certified copies of qualifications and other related documents on or before the day of the interview following communication from Human Resources.
SAHPRA comply with the provisions of Protection of Personal Information Act (POPIA); Act No. 4 of 2013. We will use your personal information provided to us for the purpose of recruitment only and more specifically for the purpose of the position/vacancy you have applied for. In the event your application was unsuccessful, SAHPRA will retain your personal information for internal audit purposes as required by policies.
Applications should be submitted through the SAHPRA Website Online Portal: SAHPRA website(https://www.sahpra.org.za) – About Us – Vacancies.
Enquiries: Technical related enquiries: Ms M Moropa, Email: mahlodi.moropa@sahpra.org.za
HR related enquiries: Ms B. Rakgotho, Email: bafedile.rakgotho@sahpra.org.za
(APPLICATIONS SENT TO THESE EMAIL ADDRESSES WILL NOT BE CONSIDERED FOR THE RECRUITMENT PROCESS). The closing date is 17 January 2025 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.
MANAGER: NAMES AND SCHEDULING
SALARY: LEVEL 12 (R 1 050 503 – R 1 237 437) per annum (TOTAL COST TO COMPANY)
Ref No.: SAHPRA 037/2024
CENTRE: PRETORIA
REQUIREMENTS: Matric certificate and a Pharmaceutical Master’s Degree at NQF level 9 as recognised by the South African Qualifications Authority (SAQA). Management qualification will be an added advantage. Proof of current registration with the South African Pharmacy Council (SAPC).
EXPERIENCE: A minimum of ten (10) years’ relevant experience in the medicines regulatory field, of which five (5) years must be at a supervisory / management level (Level 09 – 12) supporting business operations. Experience in the application of the Medicines and Related Substances Control Act 101 of 1965 (as amended), and its related Regulations. Knowledge of database management will be an added advantage.
COMPETENCIES, KNOWLEDGE, AND SKILLS: Knowledge of and experience with relevant national legislation, international standards and best practices, e.g. IMDRF, WHO, AMDF, GHWP. Knowledge of the regulatory environment. Good understanding of committee evaluation processes. MS Windows, spreadsheet and database application skills. Leadership. Ability to work in a team. Good planning and organizational skills. Excellent Communication skills (verbal, written, influencing, conflict management, presentation) and interpersonal skills. Resilience and ethical behaviour. Communication and stakeholder relationship (internal and external).
DUTIES: Manage and control the operations, processes, and innovations of the Unit: Developing and coordinating systems for management of all operations of the Unit. Managing the development, implementation and maintenance of regulations, guidelines, policies, and procedures pertaining to naming and scheduling of unregistered and registered medicines, to ensure alignment with international and national protocols, legislations and other legal requirements of the Medicines Act. Preparing monthly, quarterly, and annual reports for work done within the Unit, including monitoring of the timelines. Preparing reports to be submitted to relevant technical committees for their information, discussion, review and/or recommendation in accordance with prescribed legal requirements and standard operating procedures of SAHPRA. Managing general financial budgeting, human resources, and performance of the Names and Scheduling Unit. Performing such other functions as the Senior Manager: Clinical Evaluations Management (CEM) may duly allocate or delegate from time to time. Ensure effectiveness of the Unit operational processes: Developing
operational plans and budget for the Unit. Developing and implementing Annual Performance plan (APP) for the Unit. Ensure that the unit is aligned with the organizational needs and that resources are utilized in the most effective and efficient method. Analyzing information and processes and developing more effective or efficient processes to optimize operations, processes and strategies. Managing, developing, reviewing, and improving the accuracy of databases. Managing operations, processes, and projects within the unit. Developing (and reviewing) internal policies, in collaboration with senior management. Evaluating and improving security (physical, information, cyber). Risk Management: Identify and manage risks within the unit. Ensure that critical controls are in place and are effective. Undertake regular risk mapping exercises within the business unit. Working with the Risk team to promote an embedded risk culture. Ensure that the business unit is kept up to date with pending regulatory changes, trends, and best practices and assess the potential impact of these changes on the business unit’s processes and strategies. Develop business unit continuity plans that are fit for purpose and ensure unit resilience. Finance and Audit Management: Reviewing and ensuring submissions of revenue line listings and supporting evidence are done in line with the Finance Reporting SOP by the 7th of each month to ensure financial sustainability of the Programme. Ensure that the Programme attains and maintains an unqualified overall AG Audit outcome on previous year’s performance through Implementation of internal audit recommendations. Ensure financial sustainability of Names and Scheduling Unit. Submit annual budget estimates to the senior manager and monthly review of finance variations for finance reporting. Perform administrative duties as and when required for the efficient and effective running of the business unit, including capturing of data into the unit tracker/line listing. Manage and support Names and Scheduling Committee: Manage the training of external reviewers on SAHPRA templates, policies, and guidelines. Ensure the correctness of Names and Scheduling Committees recommendations. Oversee the execution of Names and Scheduling Committees recommendations. Monitor and evaluate performance of external reviewers.
INSTRUCTIONS TO APPLICANTS: (HOW TO APPLY): Interested applicants who meet the above requirements should forward their applications accompanied by signed covering letter attached to the comprehensive CV with the names and email addresses of three (3) referees clearly reflecting the name of the position and post reference number, and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
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. All shortlisted candidates will be subjected to a technical exercise that intends to test relevant knowledge, skill and technical elements of the job. 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.
Interested persons who meet the above-stated qualifications should forward their applications which should consist of a cover letter, detailed Curriculum Vitae, copies of qualification(s) and Identity Document. ONLY shortlisted candidates will be required to submit certified copies of qualifications and other related documents on or before the day of the interview following communication from Human Resources.
SAHPRA comply with the provisions of Protection of Personal Information Act (POPIA); Act No. 4 of 2013. We will use your personal information provided to us for the purpose of recruitment only and more specifically for the purpose of the position/vacancy you have applied for. In the event your application was unsuccessful, SAHPRA will retain your personal information for internal audit purposes as required by policies.
Applications should be submitted through the SAHPRA Website Online Portal: SAHPRA website(https://www.sahpra.org.za) – About Us – Vacancies.
Enquiries: Technical related enquiries: Mr T Sehloho, Email: tohlang.sehloho@sahpra.org.za
HR related enquiries: Ms B. Rakgotho, Email: bafedile.rakgotho@sahpra.org.za
(APPLICATIONS SENT TO THESE EMAIL ADDRESSES WILL NOT BE CONSIDERED FOR THE RECRUITMENT PROCESS). The closing date is 17 January 2025 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.
MANAGER: NAMES AND SCHEDULING
SALARY: LEVEL 12 (R 1 050 503 – R 1 237 437) per annum (TOTAL COST TO COMPANY)
Ref No.: SAHPRA 037/2024
CENTRE: PRETORIA
REQUIREMENTS: Matric certificate and a Pharmaceutical Master’s Degree at NQF level 9 as recognised by the South African Qualifications Authority (SAQA). Management qualification will be an added advantage. Proof of current registration with the South African Pharmacy Council (SAPC).
EXPERIENCE: A minimum of ten (10) years’ relevant experience in the medicines regulatory field, of which five (5) years must be at a supervisory / management level (Level 09 – 12) supporting business operations. Experience in the application of the Medicines and Related Substances Control Act 101 of 1965 (as amended), and its related Regulations. Knowledge of database management will be an added advantage.
COMPETENCIES, KNOWLEDGE, AND SKILLS: Knowledge of and experience with relevant national legislation, international standards and best practices, e.g. IMDRF, WHO, AMDF, GHWP. Knowledge of the regulatory environment. Good understanding of committee evaluation processes. MS Windows, spreadsheet and database application skills. Leadership. Ability to work in a team. Good planning and organizational skills. Excellent Communication skills (verbal, written, influencing, conflict management, presentation) and interpersonal skills. Resilience and ethical behaviour. Communication and stakeholder relationship (internal and external).
DUTIES: Manage and control the operations, processes, and innovations of the Unit: Developing and coordinating systems for management of all operations of the Unit. Managing the development, implementation and maintenance of regulations, guidelines, policies, and procedures pertaining to naming and scheduling of unregistered and registered medicines, to ensure alignment with international and national protocols, legislations and other legal requirements of the Medicines Act. Preparing monthly, quarterly, and annual reports for work done within the Unit, including monitoring of the timelines. Preparing reports to be submitted to relevant technical committees for their information, discussion, review and/or recommendation in accordance with prescribed legal requirements and standard operating procedures of SAHPRA. Managing general financial budgeting, human resources, and performance of the Names and Scheduling Unit. Performing such other functions as the Senior Manager: Clinical Evaluations Management (CEM) may duly allocate or delegate from time to time. Ensure effectiveness of the Unit operational processes: Developing
operational plans and budget for the Unit. Developing and implementing Annual Performance plan (APP) for the Unit. Ensure that the unit is aligned with the organizational needs and that resources are utilized in the most effective and efficient method. Analyzing information and processes and developing more effective or efficient processes to optimize operations, processes and strategies. Managing, developing, reviewing, and improving the accuracy of databases. Managing operations, processes, and projects within the unit. Developing (and reviewing) internal policies, in collaboration with senior management. Evaluating and improving security (physical, information, cyber). Risk Management: Identify and manage risks within the unit. Ensure that critical controls are in place and are effective. Undertake regular risk mapping exercises within the business unit. Working with the Risk team to promote an embedded risk culture. Ensure that the business unit is kept up to date with pending regulatory changes, trends, and best practices and assess the potential impact of these changes on the business unit’s processes and strategies. Develop business unit continuity plans that are fit for purpose and ensure unit resilience. Finance and Audit Management: Reviewing and ensuring submissions of revenue line listings and supporting evidence are done in line with the Finance Reporting SOP by the 7th of each month to ensure financial sustainability of the Programme. Ensure that the Programme attains and maintains an unqualified overall AG Audit outcome on previous year’s performance through Implementation of internal audit recommendations. Ensure financial sustainability of Names and Scheduling Unit. Submit annual budget estimates to the senior manager and monthly review of finance variations for finance reporting. Perform administrative duties as and when required for the efficient and effective running of the business unit, including capturing of data into the unit tracker/line listing. Manage and support Names and Scheduling Committee: Manage the training of external reviewers on SAHPRA templates, policies, and guidelines. Ensure the correctness of Names and Scheduling Committees recommendations. Oversee the execution of Names and Scheduling Committees recommendations. Monitor and evaluate performance of external reviewers.
INSTRUCTIONS TO APPLICANTS: (HOW TO APPLY): Interested applicants who meet the above requirements should forward their applications accompanied by signed covering letter attached to the comprehensive CV with the names and email addresses of three (3) referees clearly reflecting the name of the position and post reference number, and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
- Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
- A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
- No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered.
- Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
- It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment. All shortlisted candidates will be subjected to a technical exercise that intends to test relevant knowledge, skill and technical elements of the job. 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.
Interested persons who meet the above-stated qualifications should forward their applications which should consist of a cover letter, detailed Curriculum Vitae, copies of qualification(s) and Identity Document. ONLY shortlisted candidates will be required to submit certified copies of qualifications and other related documents on or before the day of the interview following communication from Human Resources.
SAHPRA comply with the provisions of Protection of Personal Information Act (POPIA); Act No. 4 of 2013. We will use your personal information provided to us for the purpose of recruitment only and more specifically for the purpose of the position/vacancy you have applied for. In the event your application was unsuccessful, SAHPRA will retain your personal information for internal audit purposes as required by policies.
Applications should be submitted through the SAHPRA Website Online Portal: SAHPRA website(https://www.sahpra.org.za) – About Us – Vacancies.
Enquiries: Technical related enquiries: Mr T Sehloho, Email: tohlang.sehloho@sahpra.org.za
HR related enquiries: Ms B. Rakgotho, Email: bafedile.rakgotho@sahpra.org.za
(APPLICATIONS SENT TO THESE EMAIL ADDRESSES WILL NOT BE CONSIDERED FOR THE RECRUITMENT PROCESS). The closing date is 17 January 2025 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.
This procurement will be managed by Supporting Health Initiatives (SHI), a Division of Wits Health Consortium Pty Ltd (WHC) for and on behalf of SAHPRA. SHI is dedicated to promoting and enabling public health activities that lead to new, significant advancements in healthcare and related fields and does this by providing resources, collaborative opportunities and project management support to partners and funders. SHI has developed a strong track record of delivering on assignments in Africa. SHI’s operations and business teams have demonstrated capacity to quickly align with partners, distribute funds, and oversee implementation.
SPECIALIST: BIOLOGICAL MEDICINE (VACCINE) CLINICAL ASSESSOR (3 POSITIONS)
Contract: Ending 31 December 2026, with possible extension based on performance.
Location: Pretoria, South Africa (Hybrid)
Reference: SAHPRA 036/2024 Remuneration: Competitive, depending on experience.
Why Join Us?
This role offers an exceptional opportunity for international experts to contribute to global health by providing expertise in the evaluation of biological medicines and vaccines. Working in a hybrid environment, you will collaborate remotely and in person, driving advancements in clinical assessments and regulatory science in South Africa and beyond.
Key Responsibilities include but are not limited to:
• Strategic Leadership: Provide technical leadership on clinical and non-clinical assessments for biological medicines, aligning with local and international regulatory strategies, WHO standards, and other National Regulatory Authorities (NRAs).
• Advisory Role: Advise on SAHPRA regulations, policies, and guidelines, ensuring compliance with global standards for biological medicines, including vaccines and biotherapeutics.
• Application Evaluation: Conduct detailed assessments of safety and efficacy aspects in applications for biological medicines (biotherapeutics, biosimilars, and vaccines) in compliance with the Medicines and Related Substances Act (Act No. 101 of 1965).
• Peer Review and Mentorship: Provide critical and analytical feedback as a peer reviewer, ensuring thorough evaluation of clinical and non-clinical sections of biological submissions. Train and mentor SAHPRA staff to enhance technical capacity.
• Global Collaboration: Represent SAHPRA in international regulatory forums, engage with industry stakeholders, and drive innovation in regulatory science.
Performance Expectation include but are not limited to:
• Collaborate effectively with multidisciplinary teams and engage with industry stakeholders on regulatory matters.
• Transfer skill to SAHPRA staff and stakeholders on Biological Medicine (Vaccine).
• Maintain resilience, adaptability, and a commitment to excellence in regulatory science.
• Champion innovation in regulatory science to improve the efficiency and effectiveness of clinical assessments for biological medicines.
• Adhere to South African data protection laws and SAHPRA's specific data protection policies
Application Criteria:
Qualifications and Expertise
• Essential:
- B. Pharm Degree or MBChB with a Master’s in Pharmacy (NQF) Level 09) as evaluated by South African Qualifications Authority (SAQA),
- Registration with professional body
- A minimum of 10 years of experience in evaluating safety and efficacy for biological medicines, including product information and patient information leaflets.
- Proven knowledge of international guidelines and regulatory standards for clinical aspects of biological medicines.
- Postgraduate qualifications in virology, vaccinology, or pharmacology of biotherapeutics.
- Expertise in clinical trials, biological dossiers, and regulatory compliance.
- Experience in hybrid or remote collaboration models.
Core Competencies
• Comprehensive understanding of clinical and non-clinical evaluation for biological medicines.
• Advanced analytical, communication, and decision-making skills for complex regulatory challenges.
• Ability to lead and mentor multidisciplinary teams with a focus on knowledge transfer.
• Resilience, adaptability, and a commitment to excellence in regulatory science.
What We Offer
• Hybrid Working Model: Flexibility to work remotely with periodic travel to South Africa, supported by advanced technology.
• Global Impact: Contribute to the safety and efficacy of biological medicines worldwide, driving public health improvements.
• Professional Growth: Collaborate with global regulatory professionals and gain exposure to cutting-edge regulatory practices.
• Collaborative Environment: Be part of a diverse and dynamic team focused on advancing public health through regulatory innovation.
Application Process
Submit your application via email to SHIproposals@supportinghi.co.za, by c.o.b 17 January 2025.
Applications must include:
• A detailed cover letter and curriculum vitae.
• Certified copies of qualifications, including professional registrations.
• A copy of a valid driver's license.
Please note: Applications must clearly state the position and reference number. Late or incomplete submissions will not be considered.
Diversity and Inclusion: SAHPRA is an equal opportunity employer committed to fostering diversity in its workforce. Candidates from underrepresented groups and individuals with disabilities are encouraged to apply.
For inquiries: contact Ms. Setlola Molepo at Setlola.Molepo@sahpra.org.za (Note: Applications sent to this email will not be processed).
Only shortlisted candidates will be contacted.
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.
This procurement will be managed by Supporting Health Initiatives (SHI), a Division of Wits Health Consortium Pty Ltd (WHC) for and on behalf of SAHPRA. SHI is dedicated to promoting and enabling public health activities that lead to new, significant advancements in healthcare and related fields and does this by providing resources, collaborative opportunities and project management support to partners and funders. SHI has developed a strong track record of delivering on assignments in Africa. SHI’s operations and business teams have demonstrated capacity to quickly align with partners, distribute funds, and oversee implementation.
SPECIALIST: SPECIALIST PHARMACOVIGILANCE
Contract: Ending 31 December 2026, with possible extension based on performance.
Location: Pretoria, South Africa (Hybrid)
Reference: SAHPRA 034/2024 Remuneration: Competitive, depending on experience.
Why Join Us?
This role offers a unique opportunity for international subject matter experts to collaborate with SAHPRA in a hybrid working environment, contributing to pharmacovigilance excellence in South Africa and globally. As a specialist, you will play a critical role in advancing safety standards for health products, driving strategic initiatives, and shaping global best practices
Key Responsibilities include but are not limited to:
• Strategic Leadership: Provide technical leadership on pharmacovigilance (PV) strategies informed by local and international reports, interventions, and guidelines from the WHO and other National Regulatory Authorities (NRAs).
• Regulatory Decision-Making: Make or recommend regulatory decisions on vaccines and biological products based on comprehensive reviews and assessments.
• Signal Detection and Investigation: Conduct signal detection, investigate adverse events, and analyse safety data from diverse sources to support informed decision-making.
• Capacity Building: Lead training and development initiatives to enhance pharmacovigilance expertise among SAHPRA staff and stakeholders.
• Global Collaboration: Represent SAHPRA in international forums and collaborate with global regulatory bodies to advance pharmacovigilance frameworks and practices.
Performance Expectation include but are not limited to:
• Foster a culture of pharmacovigilance awareness within the organization.
• Create and maintain effective pharmacovigilance systems and processes that ensure the timely detection, assessment, understanding, and prevention of adverse drug reactions .
• Timely submission of required safety reports to regulatory authorities and other relevant stakeholders.
• Develop and deliver training programs that enhance the knowledge and skills of staff, fostering a culture of pharmacovigilance excellence.
•Utilize advanced signal detection methodologies to proactively identify emerging safety issues.
•Contribute to a robust peer review process that identifies potential safety and efficacy concerns in a timely manner.
•Consistently deliver high-quality, evidence-based clinical assessments that meet deadlines and contribute to well-informed regulatory decisions.
•Collaborate effectively with multidisciplinary teams on PV-related projects.
•Strong analytical and communication skills to interpret safety data and communicate complex information effectively.
•Lead and mentor teams in a dynamic regulatory environment.
•Manage multiple priorities and deadlines efficiently with strong organizational skills.
•Proactively identify areas for improvement within SAHPRA's PV system.
•Conduct thorough reviews and assessments of vaccines and biological products.
•Make informed regulatory decisions on these products based on safety data analysis.
•Provide sound recommendations to support the decision-making process.
•Adhere to South African data protection laws and SAHPRA's specific data protection policies
Application Criteria:
Qualifications and Expertise
•Essential:
- MBChB degree with a Master’s in Public Health or Clinical Pharmacology (NQF) Level 09 as evaluated by South African Qualifications Authority (SAQA), with
- Registration with the professional bodies.
- At least 10 years of experience in public health programs or clinical research.
- Active participation in regional or international regulatory associations or advisory bodies
- A PhD in public health or pharmacology.
- Experience in hybrid or remote collaborative work environments
Core Competencies
•Comprehensive knowledge of pharmacovigilance legislation, regulations, and global standards.
•Advanced analytical and communication skills to address complex safety issues innovatively.
•Ability to mentor and lead multidisciplinary teams in dynamic regulatory environments.
•Strong organizational skills and the ability to manage multiple priorities effectively.
What We Offer
• Hybrid Working Model: Flexibility to work remotely with periodic travel to South Africa, supported by cutting-edge digital tools.
• Global Impact: Collaborate on projects that advance pharmacovigilance standards and public health globally.
• Professional Growth: Engage with leading experts in pharmacovigilance and regulatory science.
• Collaborative Environment: Be part of a diverse, innovative team committed to improving health outcomes worldwide.
Application Process
Submit your application via email to SHIproposals@supportinghi.co.za, by c.o.b 17 January 2025.
Applications must include:
• A detailed cover letter and curriculum vitae.
• Certified copies of qualifications, including professional registrations.
• A copy of a valid driver's license.
Please note: Applications must clearly state the position and reference number. Late or incomplete submissions will not be considered.
Diversity and Inclusion: SAHPRA is an equal opportunity employer committed to fostering diversity in its workforce. Candidates from underrepresented groups and individuals with disabilities are encouraged to apply.
For inquiries: contact Ms. Bafedile Rakgotho at Bafedile.Rakgotho@sahpra.org.za (Note: Applications sent to this email will not be processed).
Only shortlisted candidates will be contacted.