SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA) VACANCIES

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INSPECTOR: GOOD MANUFACTURING PRACTICE (GMP)
(FIXED TERM CONTRACT: UNTIL 30 SEPTEMBER 2025)
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 23/2025
CENTRE: Pretoria
 
REQUIREMENTS: 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 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 NQF or Honours degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of five (5) of experience in pharmaceutical regulatory or GMP environment. Extensive knowledge of GMP regulations and industry practice, as well as substantial experience in undertaking GMP inspections within a regulatory environment.
Grade 2: Four-year Bachelor of Pharmacy degree NQF level 8 as recognised by SAQA and registration as a Pharmacist with South African Pharmacy Council (SAPC) and a minimum of three (3) years of experience in a pharmaceutical regulatory or GMP environment. Extensive knowledge of GMP regulations and industry practice, as well as substantial experience in undertaking GMP inspections within a regulatory environment or an Honours degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA, plus a minimum of ten (10) years of experience in pharmaceutical regulatory or GMP environment. Extensive knowledge of GMP regulations and industry practice, as well as substantial experience in undertaking GMP inspections within a regulatory environment.
 
COMPETENCIES, KNOWLEDGE AND SKILLS: *Comprehensive and sound knowledge of all relevant legislation, protocols, regulations, and guidelines pertaining to the Medicines and Related Substances Act 101 of 1965. *Good verbal and numerical reasoning skills to allow analysis and interpretation of written and numerical data. *Good communication skills (verbal, written, conflict management and resolution). *Resilience. *Delivery of service objectives with professional excellence and efficiency.
*Ability to make effective decisions by using evidence and knowledge to support accurate, expert decisions and advice while carefully considering the implications of such a decision. *Ability to work unsupervised for long periods. *Ability to work within a team environment. *Good planning and organisational skills. *Ability to meet tight deadlines and manage multiple, often competing priorities.
*Knowledge of MS Office. *Ethical behaviour and adherence to the SAHPRA Code of Conduct. *At SAHPRA, we adhere to our core values: Ubuntu. Responsiveness. Integrity. Transparency. Efficiency. Excellence.
 
DUTIES: Inspect pharmaceutical manufacturing sites for compliance with Good Manufacturing Practices as accepted by SAHPRA. Assess and evaluate GMP inspection reports of other regulatory authorities on international pharmaceutical manufacturing sites where medicines for exportation to South Africa are manufactured. Perform pre- and post-registration inspections on information submitted in a medicine application dossier. Perform a once-off evaluation on information submitted by HCR (Applicants). Work closely across inspection teams, SAHPRA departments, and external regulators to ensure inspection activities are planned and communicated effectively.
Evaluate Standard Operating Procedures (SOPs) of the Inspectorate for compliance with GMP/GWP guidelines as adopted by SAHPRA. To contribute to the Inspectorate’s compliance management process by ensuring that instances of suspected or known non-compliance are handled appropriately. Prepare reports for SAHPRA and relevant Advisory Committees and the Finance Unit.
Liaise with inspectors from international regulatory authorities. Assist in minuting the recommendations of relevant advisory committees of SAHPRA applicable to the activities of the Inspectorate Unit. Interview members from the industry to discuss SAHPRA Board resolutions and requirements of the Medicine and Related Substances Act, No. 101 of 1965 [and medicines quality issues. To provide advisory support to key stakeholders, including participation in regulatory meetings and conferences, external presentations all while demonstrating sound industry and technical knowledge. Record statistics of generated and peer-reviewed reports. Manage the associated risks and audit queries through a clear governance process, ensuring that the correct procedure is followed, care taken, and ethical behaviour demonstrated when managing inspection related resources and that all relevant records and evidence are sufficiently maintained for audit purposes.
 
 
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 a 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 shortlisted candidates only. Applicants who have not been contacted within three (3) months after the closing date should consider that their application as being 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 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 the 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: https://www.sahpra.org.za/vacancies.
• For enquiries: Please contact Mr Itumeleng Mosenyi, HR Business Partner, via email at itumeleng.mosenyi@sahpra.org.za. NOTE: APPLICATIONS SUBMITTED TO THIS EMAIL ADDRESS WILL NOT BE CONSIDERED AS PART OF THE RECRUITMENT PROCESS.

 
The closing date is 26 May 2025 at 16:00.
 
 
 
 
 

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MEDICINE REGISTRATION OFFICER: NAMES AND SCHEDULING 
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 20/2025 
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. 
 
EXPERIENCE:
Grade 1 – A minimum of two (2) years of relevant experience post internship and community service. Regulatory experience will be an added advantage. 
Grade 2 –A minimum of five (5) years of relevant experience post internship and community service. Regulatory experience will be an added advantage. 
 
COMPETENCIES, KNOWLEDGE, AND SKILLS: Knowledge and application of the Medicines and Related Substances Control Act (101 of 1965), as amended, and its related Regulations, concerning the regulation of medicines in terms of quality, safety, and efficacy. Basic knowledge of Regulatory frameworks, policies, and processes. Basic understanding of medicine registration and harmonised standards. 

• Excellent written and verbal communication skills 
• Attention to detail and strong organisational skills 
• Ability to work independently and as part of a multidisciplinary team 
• Decision-making skills 
• Report writing proficiency 
• Interpersonal skills 
• Confidentiality
• Ethical behaviour 
• Change management 
• Knowledge management 
• Service delivery innovation 
• Problem solving and analysis 
• Client orientation and customer focus 
• Proactive stakeholder management 
• Situational adaptability 
• Collaboration

 
DUTIES: Evaluation of the name and schedule of new applications. *Evaluation of new application’s PI/PILs. *Evaluate proprietary name change applications. *Facilitate the evaluation of new chemical entities and rescheduling applications. *Allocate applications to reviewers for evaluation and follow-up thereof. *Identify schedules for substances, new chemical entities, authorised prescribers and update the schedules accordingly. *Prepare a submission to the Minister of Health for approval of amendments of the schedules. *Support and prepare reports/documents for the Names and Scheduling Advisory Committee. *Referral of applications to various advisory committees and execution of recommendations thereof. *Responsible for updating standard operating procedures, templates, guidelines and applicable documents as per the defined processes. *Preparation of documents and presentations as requested by the Manager, Senior Manager, the Chief Regulatory Officer and the Chairperson of the committee. *Prepare, attend, and participate in discussions during meetings. *Attend to queries from various stakeholders. *Provide technical advice and information to all stakeholders. *Attend to queries from the Manager, Senior Manager, other Programmes, the Legal Unit and the Office of the Chief Regulatory Officer. 
 
 
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY): 

• Interested persons who meet the above-stated requirements should submit their application, 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 a 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 to be 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: https://www.sahpra.org.za/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 23 May 2025 at 16:00. 
 
 
 
 
 
 

​ 
 
 
 
 
INSPECTOR: GOOD MANUFACTURING PRACTICE (GMP)
(FIXED TERM CONTRACT: UNTIL 30 SEPTEMBER 2025)
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 23/2025
CENTRE: Pretoria
 
REQUIREMENTS: 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 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 NQF or Honours degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of five (5) of experience in pharmaceutical regulatory or GMP environment. Extensive knowledge of GMP regulations and industry practice, as well as substantial experience in undertaking GMP inspections within a regulatory environment.
Grade 2: Four-year Bachelor of Pharmacy degree NQF level 8 as recognised by SAQA and registration as a Pharmacist with South African Pharmacy Council (SAPC) and a minimum of three (3) years of experience in a pharmaceutical regulatory or GMP environment. Extensive knowledge of GMP regulations and industry practice, as well as substantial experience in undertaking GMP inspections within a regulatory environment or an Honours degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA, plus a minimum of ten (10) years of experience in pharmaceutical regulatory or GMP environment. Extensive knowledge of GMP regulations and industry practice, as well as substantial experience in undertaking GMP inspections within a regulatory environment.
 
COMPETENCIES, KNOWLEDGE AND SKILLS: *Comprehensive and sound knowledge of all relevant legislation, protocols, regulations, and guidelines pertaining to the Medicines and Related Substances Act 101 of 1965. *Good verbal and numerical reasoning skills to allow analysis and interpretation of written and numerical data. *Good communication skills (verbal, written, conflict management and resolution). *Resilience. *Delivery of service objectives with professional excellence and efficiency.
*Ability to make effective decisions by using evidence and knowledge to support accurate, expert decisions and advice while carefully considering the implications of such a decision. *Ability to work unsupervised for long periods. *Ability to work within a team environment. *Good planning and organisational skills. *Ability to meet tight deadlines and manage multiple, often competing priorities. *Knowledge of MS Office. *Ethical behaviour and adherence to the SAHPRA Code of Conduct. *At SAHPRA, we adhere to our core values: Ubuntu. Responsiveness. Integrity. Transparency. Efficiency. Excellence.
 
DUTIES: Inspect pharmaceutical manufacturing sites for compliance with Good Manufacturing Practices as accepted by SAHPRA. Assess and evaluate GMP inspection reports of other regulatory authorities on international pharmaceutical manufacturing sites where medicines for exportation to South Africa are manufactured. Perform pre- and post-registration inspections on information submitted in a medicine application dossier. Perform a once-off evaluation on information submitted by HCR (Applicants). Work closely across inspection teams, SAHPRA departments, and external regulators to ensure inspection activities are planned and communicated effectively.
Evaluate Standard Operating Procedures (SOPs) of the Inspectorate for compliance with GMP/GWP guidelines as adopted by SAHPRA. To contribute to the Inspectorate’s compliance management process by ensuring that instances of suspected or known non-compliance are handled appropriately. Prepare reports for SAHPRA and relevant Advisory Committees and the Finance Unit.
Liaise with inspectors from international regulatory authorities. Assist in minuting the recommendations of relevant advisory committees of SAHPRA applicable to the activities of the Inspectorate Unit. Interview members from the industry to discuss SAHPRA Board resolutions and requirements of the Medicine and Related Substances Act, No. 101 of 1965 [and medicines quality issues. To provide advisory support to key stakeholders, including participation in regulatory meetings and conferences, external presentations all while demonstrating sound industry and technical knowledge. Record statistics of generated and peer-reviewed reports. Manage the associated risks and audit queries through a clear governance process, ensuring that the correct procedure is followed, care taken, and ethical behaviour demonstrated when managing inspection related resources and that all relevant records and evidence are sufficiently maintained for audit purposes.
 
 
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 a 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 shortlisted candidates only. Applicants who have not been contacted within three (3) months after the closing date should consider that their application as being 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 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 the 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: https://www.sahpra.org.za/vacancies.
• For enquiries: Please contact Mr Itumeleng Mosenyi, HR Business Partner, via email at itumeleng.mosenyi@sahpra.org.za. NOTE: APPLICATIONS SUBMITTED TO THIS EMAIL ADDRESS WILL NOT BE CONSIDERED AS PART OF THE RECRUITMENT PROCESS.

 
The closing date is 26 May 2025 at 16:00.
 
 
 
 
 
 

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Erratum: On 09 May 2025, an advert for Clinical Trials (Serious Adverse Events (SAES) was published without the type of employment. The correct type of employment for this position is a fixed-term contract as updated below. The applicants who have already applied based on the previous advert, need not re-apply. 
 
1-YEAR CONTRACT ADMIN OFFICER – CLINICAL TRIALS (SERIOUS ADVERSE EVENTS (SAES) 
SALARY: R 293 131.00 – R 345 288.00 per annum (TOTAL COST TO COMPANY) 
Ref No.: SAHPRA 21/2025 
CENTRE: PRETORIA 
 
REQUIREMENTS: Matric certificate and post-matric certification/Diploma with Training/Certification as a qualified post-basic Pharmacist Assistant or degree in health sciences and registration with a Professional Body. Basic Pharmaceutical knowledge is a requirement.
 
EXPERIENCE:  One (1) to two (2) years of experience with MS Office (Excel and Word), email/Outlook, office administration and filing. Regulatory experience will be an added advantage. 


COMPETENCIES, KNOWLEDGE, AND SKILLS: Knowledge and application of the Medicines and Related Substances Control Act (101 of 1965), as amended, and its related Regulations, concerning the regulation of medicines in terms of quality, safety, and efficacy. Knowledge and understanding of the use of data capturing. 

• Strong administrative, planning and organisational skills 
• Good communication skills (verbal and written) 
• Computer literacy (MS Office – Excel and Word) 
• Attention to detail 
• Ability to work well under pressure 
• Team player, but also able to work independently 
• Resilience
• Assertiveness
• Innovative thinking 
• Deadline driven 
• Willingness to work extended hours as and when required. 

 
DUTIES: Screen and admin support of SAEs reported during the clinical trial process: Quality admin screen SAE reports for completion. Upload SAE correspondence and related documentation following standard operating procedures (SOP) and save on the shared drive. Capture the report on the SAE spreadsheet/tracker. Allocate SAE correspondence to technical staff and monitor reports received. Allocate correspondence to technical staff. SAE data management - VigiFlow database and assist with data information: Capture the SAE reports on VigiFlow database – ensure all the relevant fields are filled and all MedDRA terminologies are properly indicated for useful data. Assist in extracting information relating to a clinical trial in question or a sample, as determined by the Assessor from time to time, based on trends. Attend stakeholder queries on SAEs and assist with other activities related to safety reporting: Identify SAEs reports with deficiencies and request the missing information. Type the letters on Serious Adverse Events Reports as applicable and mailing correspondences to applicants. Attend to queries relating to SAEs or escalate to the responsible Assessor. Assist in attending to internal and external audit queries. 
 
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY): 

• Interested persons who meet the above-stated requirements should submit their application, 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 a 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 that their application to be 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 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: https://www.sahpra.org.za/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 23 May 2025 at 16:00. 
 
 
 
 
 

​MEDICINES CONTROL OFFICER: REGULATORY COMPLIANCE
(FIXED TERM CONTRACT: UNTIL 30 SEPTEMBER 2025)
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 24/2025
CENTRE: Pretoria
 
REQUIREMENTS: 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). 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 and registration as a Pharmacist with the SAPC at NQF level 8 as recognised by SAQA plus a minimum of three (3) years’ experience as a practising pharmacist post community service, of which two (2) should be in pharmaceutical regulatory environment.
Grade 2: Four-year Bachelor of Pharmacy degree and registration as a Pharmacist the SAPC at NQF level 8 as recognised by SAQA plus a minimum of five (5) years’ experience as a practising pharmacist post community service, of which three (3) should be in pharmaceutical regulatory environment.
 
COMPETENCIES, KNOWLEDGE AND SKILLS
*A solid understanding of application procedures. *Medicines Act as Amended and its Regulations.
*Consolidated Schedules. *Planning and organisational skills. *Interpersonal skills. *Investigation skills.
*Computer skills and knowledge of MS Office. *Drive and self-management skills. *Communication skills.
*Report writing. *Resilience. *Assertiveness. *Ethical behaviour. *Ability to work under pressure and irregular hours. *Professionalism. *Ethical conduct and adherence to the SAHPRA Code of Conduct.
*Integrity.
 
DUTIES: Investigation of compliance / non-compliance and reporting: Investigate matters related to the contravention of the Medicines Act (medical device establishments, pharmacies, complementary medicine establishments, ports of entry, illegal establishments, etc. Investigate complaints relating to the advertising of medicines (control of promotional, marketing, and advertising activities). Allocated post-marketing surveillance of advertising cases. Issuing of authorisations for samples, reference standards, etc relating to import, export. Processing of applications for donations. Processing of applications for Section 36. Coordinate, review applications for destruction of scheduled medicines/substances, medical devices, and IVDs.
Cooperation and collaborations with stakeholders locally and abroad. Review applications and compile possession permits for manufacturing and research. Detention/seizure of non-compliant products. Coordinate and schedule allocated investigations with the team inspector as per allocation. Investigate and attend to industry /applicant queries. Conduct joint inspection/s with law enforcement agencies (e.g. BMA, SARS, HPCSA, SAVC, SAPS & SAPC). Perform all activities according to relevant SOPs.
Responsible for overall Product Quality defects/ Complaints activities requiring Alerts and Recalls actions (Substandard/Falsified medical products): Identify activities relating to Product Quality defects, specifically those requiring alerts. Apply the SOP for alerts/recalls timely. Ensure that management is updated. Ensure that appropriate communication is prepared for approval. Ensure that draft information for internal and external stakeholders is available for review and approval.
Ensure that Applicants comply with the conditions of alerts/recalls. Update the website notifications. Prepare a monthly report for the manager. Write an annual report for alerts/recalls.
Provide feedback to relevant SAHPRA unit/s where applicable.
Inspection and reporting: Inspect allocated sites (e.g. Cannabis sites, pharmacies, wholesalers – site can be based on the complaint received). Reports to be completed within 30 working days from the inspection date. Help review the SOP for Investigations and conduct inspections in accordance with SOP. Participate in risk and audit enquiries (internal and external audits). Compile reports and resolutions for the Licensing Unit or referral unit applicable. Ensure the reports comply with QMS approved formats.
Lodge criminal cases with the authorities and appear in court when subpoenaed: Where criminal offenses are identified, open criminal cases with the South African Police Services (SAPS) and write affidavits/statements. Attend to court as per subpoena. Assist SAPS/National Prosecuting Authority with writing affidavits for crimes relating to contravention of the Medicines Act.
Strengthen Cooperation with stakeholders (training, information sharing): Participate in Border Management Authority, South African Revenue Services, SAPS, Health Professions Council for South Africa and SAPC as aligned with Memoranda of Understanding (MoUs). Attend meetings, conferences and briefings with stakeholders, including workshops and training overseas. Support the initiatives of stakeholders which are relating to contravention of the Medicines Act. Support the Communication Unit’s queries relating to media. Training of stakeholders. Consult with internal core business and support units whenever applicable (Manager, Senior Manager, Executive Management, Advisory Committees, Complementary Medicines, Medical Device Unit, Section 21, Names and Scheduling, Veterinary, Biological). Foster cooperation and collaboration with relevant SAHPRA units to enhance appropriate regulatory outcomes on matters. Foster cooperation and collaboration with statutory bodies, industry associations, activist organisations and media. Attend operations quarterly with law enforcement agencies.
Reporting: Participate in risk and audit queries relating to your focal area. Submit and present performance reports on your focal area monthly. Comply with QMS requirements for a clean audit.
Review SOP and Guidelines for alerts, recalls and withdrawals as required.
 
 
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 have a 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 shortlisted candidates only. Applicants who have not been contacted within three (3) months after the closing date should consider that their application to be 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 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 the 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:
• https://www.sahpra.org.za/vacancies.
• For enquiries: Please contact Mr Itumeleng Mosenyi, HR Business Partner, via email at itumeleng.mosenyi@sahpra.org.za. NOTE: APPLICATIONS SUBMITTED TO THIS EMAIL ADDRESS WILL NOT BE CONSIDERED AS PART OF THE RECRUITMENT PROCESS.

 
The closing date is 24 May 2025 at 16:00.

​ADMIN OFFICER – CLINICAL TRIALS (SERIOUS ADVERSE EVENTS (SAES)) 
SALARY: R 293 131.00 – R 345 288.00 per annum (TOTAL COST TO COMPANY) 
Ref No.: SAHPRA 21/2025 
CENTRE: PRETORIA 
 
REQUIREMENTS: Matric certificate and post-matric certification/Diploma with Training/Certification as a qualified post-basic Pharmacist Assistant or degree in health sciences and registration with a Professional Body. Basic Pharmaceutical knowledge is a requirement. 
 
EXPERIENCE: One (1) to two (2) years of experience with MS Office (Excel and Word), email/Outlook, office administration and filing. Regulatory experience will be an added advantage. 
 
COMPETENCIES, KNOWLEDGE, AND SKILLS: Knowledge and application of the Medicines and Related Substances Control Act (101 of 1965), as amended, and its related Regulations, concerning the regulation of medicines in terms of quality, safety, and efficacy. Knowledge and understanding of the use of data capturing. 

• Strong administrative, planning and organisational skills 
• Good communication skills (verbal and written) 
• Computer literacy (MS Office – Excel and Word) 
• Attention to detail 
• Ability to work well under pressure 
• Team player, but also able to work independently 
• Resilience
• Assertiveness
• Innovative thinking 
• Deadline driven 
• Willingness to work extended hours as and when required 

 
DUTIES: Screen and admin support of SAEs reported during the clinical trial process: Quality admin screen SAE reports for completion. Upload SAE correspondence and related documentation following standard operating procedures (SOP) and save on the shared drive. Capture the report on the SAE spreadsheet/tracker. Allocate SAE correspondence to technical staff and monitor reports received. Allocate correspondence to technical staff. SAE data management - VigiFlow database and assist with data information: Capture the SAE reports on VigiFlow database – ensure all the relevant fields are filled and all MedDRA terminologies are properly indicated for useful data. Assist in extracting information relating to a clinical trial in question or a sample, as determined by the Assessor from time to time, based on trends. Attend stakeholder queries on SAEs and assist with other activities related to safety reporting: Identify SAEs reports with deficiencies and request the missing information. Type the letters on Serious Adverse Events Reports as applicable and mailing correspondences to applicants. Attend to queries relating to SAEs or escalate to the responsible Assessor. Assist in attending to internal and external audit queries. 
 
 
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY): 

• Interested persons who meet the above-stated requirements should submit their application, 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 a 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 that their application to be 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 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: https://www.sahpra.org.za/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 23 May 2025 at 16:00.