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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, 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: PRE-REGISTRATION 
(PHARMACEUTICAL EVALUATION MANAGEMENT) (X3) 
SALARY: R700 105.00 – R888 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 and community service in line with governing frameworks. 
Ref No.: SAHPRA 13/2025 
CENTRE: Pretoria 
 
REQUIREMENTS: ● Applicants must be in possession of a Matric certificate and appropriate four-year Bachelor of Pharmacy degree and registration as a pharmacist with the South African Pharmacy Council (SAPC) at NQF Level 8 as recognised by the South African Qualifications Authority (SAQA) or an Honours degree in related health sciences at NQF level 8 as recognised by SAQA. A relevant master’s qualification at NQF Level 9 as recognised by SAQA will be an added advantage. Valid driver’s licence. 
 
EXPERIENCE
Grade 1: Four-year Bachelor of Pharmacy degree at NQF Level 8 as recognised by SAQA and registration as a pharmacist with the SAPC plus a minimum of three (3) years regulatory experience (post community service) in pharmaceutical or related medicines regulation or medicine production quality assurance; OR an Honours degree in related health sciences at NQF Level 8 as recognised by SAQA plus a minimum of five (5) years regulatory experience in pharmaceutical or related medicines regulation or medicine production quality assurance. 
Grade 2: Four-year Bachelor of Pharmacy degree at NQF Level 8 as recognised by SAQA and registration as a pharmacist with the SAPC plus a minimum of five (5) years regulatory experience (post community service) in pharmaceutical or related medicines regulation or medicine production quality assurance OR an Honours degree in related health sciences at NQF Level 8 as recognised by 
SAQA plus a minimum of eight (8) years regulatory experience in pharmaceutical or related medicines regulation or medicine production quality assurance. 
 
COMPETENCIES, KNOWLEDGE AND SKILLS: Knowledge and application of the Medicines and Related Substances Act, 101 of 1965, as amended, and its related Regulations and guidelines. Knowledge of the technical aspects for the evaluation of the quality and efficacy (bioequivalence) of medicines. Computer literacy and sound working knowledge of computer software packages. Technical and scientific aspects of medicine regulation. Evaluation guidelines as prescribed by the relevant regulatory authorities. Planning and organisational skills. Leadership skills. Coordination skills. Written and verbal communication skills. Diversity management. Time management. Good telephone etiquette. Supervisory skills. 
 
DUTIES: Evaluation of new applications and peer-reviewing of new applications: Generate evaluation report(s) for each new application (new chemical entities (NCE) and Generics) in compliance with required template and adopted regulatory/scientific standards and submit for peer review. Following the peer review process, amend the report(s) accordingly to generate a list of queries to the applicant using the correct templates. Peer-review primary report(s) compiled by other reviewers. Prepare reports for the internal working groups and where necessary present at advisory committee for complex scientific matters. Prepare query letters to applicants. 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 reports for each response application and submit for peer review in compliance with required template and adopted regulatory/scientific standards and submit for peer review. Following the peer review process, amend the report accordingly to generate a list of queries to the applicant, if necessary. Peer review other evaluators’ response reports, according to the required template and adopted regulatory/scientific standards. Prepare reports for the internal working groups and where necessary present at advisory committee for complex scientific matters. Prepare query letters to applicants. 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 reports for each application and submit for peer review. Following the peer review process, amend the technical screening reports accordingly to generate a list of queries to the applicant using the correct templates. Peer review technical screening reports compiled by other reviewers. Prepare screening query/screening rejection letter to the applicant. Provide quality assurance of reports and facilitate resolutions on technical matters. 
Develop and update guidelines, SOPs and templates: Review existing guidelines, standard operating procedures (SOPs) and templates and update when necessary. Provide training on guidelines, SOPs and templates. Create new guidelines, SOPs and templates where relevant. Provide regular work plans and output to the unit manager (qualitative and quantities report). Perform any other related duty as requested by the manager/senior manager. 
Form part of technical working groups or special projects and also provide support to the unit as well as to advisory committees: Participate in special projects and registration groups. Lead and manage assessments peer review and discussion working group where relevant. Compile discussion documents and reports. Provide regular training to new internal medicine registration officers (MROs) and external evaluators. Take comprehensive notes of discussions of relevant discussions. Prepare documents for the SAHPRA management/RC meetings. 
Risk Management and Audit: Adhere to SOPs and Guidelines. Create and maintain databases. Use the most current templates and guidelines. Provide and attend relevant training as may be necessary. Align with Quality Management System requirements. Align with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, World Health Organisation, International Pharmaceutical Regulators Programme and other international standards. 
 
 
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY): 
Interested persons who meet the above-stated requirements should submit their application, clearly state the position name and post reference number, including a signed cover letter, clearly state the position name and post reference number, detailed Curriculum Vitae (CV) with the names and email addresses of three (3) referees, copies of required qualifications (including matric) 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. 
  • Should you be in possession of foreign qualification, your application must be accompanied by an evaluation certificate (report) from the SAQA. 
  • Incomplete applications or applications without the aforementioned documents or information will not be considered. 
  • No late applications will be accepted. Any submissions received after the specified date and time will not be considered, and CVs will not be returned. 
  • Due to the larger number of responses anticipated, communication will be limited to short-listed candidates only. Applicants who have not been contacted within three (3) months after the closing date should consider their application was unsuccessful. 
  • Shortlisted candidates will be expected to attend selection interviews at a date, time, and location as specified by SAHPRA. 
  • Applicants should note that pre-suitability checks will be conducted after they have been shortlisted. Their appointment is subject to positive outcomes from these checks, which include security clearance, verification of qualifications, criminal records, credit checks, citizenship status, and work experience. 
  • SAHPRA is committed to being an equal opportunity employer. When filling vacant positions, the entity will consider the principles outlined in Section 195(1)(i) of the Constitution of the Republic South Africa, Act 108 of 1996, and the Employment Equity Act, 55 of 1998. Applicants with disabilities are encouraged to apply and indicate their disability status, which will be appreciated. 
  • SAHPRA reserves the right not to make any appointment(s) to the advertised post(s). 
  • SAHPRA adheres to the provisions of the Protection of Personal Information Act (POPIA), 4 of 2013. CVs will not be returned, as the personal information you provide will be used solely application is unsuccessful, your personal information will be retained for internal audit purposes. 
  • Applications should be submitted through the SAHPRA Website Online Portal: https://www.sahpra.org.za – About Us – Vacancies. 
  • For enquiries: Please contact Mr T Khunou, HR Business Partner, via email at Tshepo.Khunou@sahpra.org.za. NOTE: APPLICATIONS SUBMITTED TO THIS EMAIL ADDRESS WILL NOT BE CONSIDERED AS PART OF THE RECRUITMENT PROCESS. 
 
The closing date is 31 March 2025 at 16:00.










​The South African Health Products Regulatory Authority (SAHPRA) is the National Medicines Regulatory Authority established in terms of the Medicines and Related Substances Act, 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: PHARMACOVIGILANCE (CONTRACT FOR 24-MONTHS) 
SALARY: R700 105.00 – R888 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 12/2025 
CENTRE: PRETORIA 
 
REQUIREMENTS: Matric certificate and appropriate four-year degree in Pharmacy at NQF Level 8 as recognised by the South African Qualifications Authority (SAQA) and registration with a Professional Body (South African Pharmacy Council). A relevant Master’s degree will be an added advantage. A valid driver’s licence. 
 
EXPERIENCE:
Grade 1 – A minimum of two (2) years of Pharmacovigilance experience post internship and Community Service. Regulatory experience will be an added advantage. 
Grade 2 –A minimum of five (5) years of Pharmacovigilance experience post internship and Community Service. 
 
COMPETENCIES, KNOWLEDGE, AND SKILLS: Knowledge and application of the Medicines and Related Substances Act, 101 of 1965, as amended, and its related Regulations, with respect to the regulation of medicines in terms of quality, safety, and efficacy. Basic knowledge of the medicines regulatory framework, policies, and process. Knowledge and understanding of clinical pharmacology. Basic understanding of medicine registration and harmonisation. 
  • Excellent interpersonal and communication skills (written and verbal) 
  • Critical thinking 
  • Ability to exercise good judgment and solve problems quickly and effectively 
  • Computer skills 
  • Solution orientated 
  • Ability to work under pressure 
  • Ability to maintain high levels of confidentiality 
  • Interpersonal skills 
  • Change management 
  • Knowledge management 
  • Service delivery innovation 
  • Problem-solving and analysis 
  • Client orientation and customer focus 
  • Proactive stakeholder management 
  • Situational adaptability 
  • Collaboration
 
DUTIES: Operational Management: Responsible for the accurate and timeous assessment of safety documents received, and performance as per the defined processes. Preparing comprehensive reports for various purposes (e.g., regulatory submissions, advisory committees, internal communication). Preparing accurate, timely, and well-documented reports that meet regulatory requirements. Documenting decision-making processes and justifications. Writing clear, concise, and evidence-based reports. Producing scientific peer-reviewed evaluation reports. Provide technical and administrative support to committees. Engaging stakeholders relating to regulatory matters. Manage product review systems. Processing applications received for approval. Support the AEFI management: Conduct case management and causality assessments for AEFI cases for all registered vaccines. Establish integrated procedures and processes for monitoring, reporting and assessment of vaccine-related safety concerns. Train healthcare professionals in the provinces on AEFI management, causality assessment and AEFI reporting procedures and tools. Review, update and implement updated procedures and processes for the management of registered vaccines. Support Pharmacovigilance (PVC) and National Immunisation Safety Expert Committee (NISEC): Support the PVC/NISEC both technically and administratively. Coordinate all PVC/NISEC meetings and minutes thereof. Allocate case files for clinical assessment to both pharmacovigilance technical officers and NISEC members. Update AEFI cases on reports management system as per the NISEC causality assessment outcome. Prepare and provide monthly reports/statics on AEFI cases. Ensure case closure and provision of feedback to the provinces. Prepare and communicate all regulatory decisions as per the meeting discussions. Coordinate and support provinces on vaccines and therapeutics safety reporting and case management: Support and strengthen linkages with provincial Departments of Health (DoH) to facilitate SAHPRA decentralised pharmacovigilance activities. Implement procedures and strengthen coordination with provincial and district-level DoH staff to improve AEFI and ADR reporting and case management activities. Develop/update reporting procedures for both AEFIs and therapeutics ADRs and co-ordinate finalisation. Strengthen provincial safety committees and linkages to SAHPRA. Training and outreach: Co-ordinate and implement trainings for healthcare professionals in both private and private sectors. Co-ordinate medicine safety awareness webinars and workshops. Work closely with provinces and stakeholders for planning and implementation of outreach programmes for both healthcare professionals and the public. Benefit-Risk Evaluation: Critically assess Risk Management Plans (RMP)/Periodic Benefit-risk Evaluation Reports (PBRER)/Periodic Safety Update Reports (PSUR)/Summary of Benefit-Risk Evaluation reports/Safety signals as submitted by applicants or received from any other stakeholder. Write clear, concise, and evidence-based reports. Produce scientific peer-reviewed scientific reports for discussion. Timeous preparation and submission of assessment reports to ensure compliance with targets and timelines. Prepare and publish safety-related communications timeously. ICSR Management: Processing and management of ADR/ADE reports received. Clinical assessment of serious adverse reaction reports. Co-ordinate and participate in causality assessment meetings of serious cases and cases of public interest. Conduct signal detection/assessment and necessary investigation. Financial Management: Collating, compiling, and submitting accurate reports in a timely manner to satisfy statutory and business requirements as well as be able to communicate key financial messages to stakeholders with clarity and consistency. Provide general advice on all related financial matters to all relevant colleagues involved, directly or indirectly, in the financial circuit. Monitors and maintains all required financial records for compliance and audit to all agreed requirements. Collate financial data and reports for analysis and to facilitate decision making. Governance, Compliance and Risk: Achieve and maintain process quality. Adherence with the Occupational Health and Safety Act (OHSA) to ensure a safe and healthy working environment. Ensure adherence to all process quality assurance requirements. Assist with Performance Reporting within the predetermined timeline. Identify and record operational risks and consult with the Unit Manager. Mitigate risks within operational control. Resolve the operational risks effectively and timeously. Filing of evaluation reports under respective product folders. Assisting with the compliance of the Quality Management System requirements of the unit. Identify and record operational risks and consult with Unit Manager. Development and maintenance of guiding principles (SOPs, guidelines, policies, etc.) to ensure consistency, efficiency and alignment of PV processes. Identify and implement new approaches to improve and to maintain consistency, efficiency and alignment of PV processes. Update policy documents to improve and maintain high levels of operational efficiency and effectiveness. People Management: Self-management. Manage own Performance and Individual Development Plan. Living the SAHPRA values. Sharing knowledge with and informal coaching peers (as applicable). 
 
 
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY): 
  • Interested persons who meet the above-stated requirements should submit their application, clearly state the position name and post reference number, including a signed cover letter, clearly state the position name and post reference number, detailed Curriculum Vitae (CV) with the names and email addresses of three (3) referees, copies of required qualifications (including matric) 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. 
  • Should you be in a possession of foreign qualification, your application must be accompanied by an evaluation certificate (report) from the South African Qualifications Authority (SAQA). 
  • Incomplete applications or applications without the aforementioned documents or information will not be considered. 
  • No late applications will be accepted. Any submissions received after the specified date and time will not be considered, and CVs will not be returned. 
  • Due to the larger number of responses anticipated, communication will be limited to short-listed candidates only. Applicants who have not been contacted within three (3) months after the closing date should consider their application was unsuccessful. 
  • Shortlisted candidates will be expected to attend selection interviews at a date, time, and location as specified by SAHPRA. 
  • Applicants should note that that pre-suitability checks will be conducted after they have been shortlisted. Their appointment is subject to positive outcomes from these checks, which include security clearance, verification of qualifications, criminal records, credit checks, citizenship status, and work experience. 
  • SAHPRA is committed to being an equal opportunity employer. When filling vacant positions, the entity will consider the principles outlined in Section 195(1)(i) of the Constitution of the Republic of South Africa, Act 101 of 1996, and the Employment Equity Act, 55 of 1998. Applicants with disabilities are encouraged to apply and indicate their disability status, which will be appreciated. 
  • SAHPRA reserves the right not to make any appointment(s) to the advertised post(s).
  • SAHPRA adheres to the provisions of the Protection of Personal Information Act (POPIA), 4 of 2013. CVs will not be returned, as personal information you provide will be used solely for recruitment purposes, specifically for the position or vacancy you have applied for. If your application is unsuccessful, your personal information will be retained for internal audit purposes. 
  • Applications should be submitted through the SAHPRA Website Online Portal: SAHPRA website (https://www.sahpra.org.za) – About Us – Vacancies. 
  • For enquiries: Please contact Ms Bafedile Rakgotho, HR Business Partner, via email at bafedile.rakgotho@sahpra.org.za. NOTE: APPLICATIONS SUBMITTED TO THIS EMAIL ADDRESS WILL NOT BE CONSIDERED AS PART OF THE RECRUITMENT PROCESS. 
 
The closing date is 19 March 2025 at 16:00.