SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA) VACANCIES

​ 
 
BORDER MEDICINES CONTROL TECHNICIAN
SALARY LEVEL 07: R434 554.00–R461 223.00 per annum (Total cost to company)
Ref No.: SAHPRA 08/2025
CENTRE: Cape Town Harbour and Airport
 
REQUIREMENTS: ● Applicants must be in possession of a Matric certificate and Advanced Certificate: Pharmacy Technical Support qualification and are registered with the South African Pharmacy Council (SAPC) as per current Pharmacy Act Regulations.
 
EXPERIENCE: ● A minimum of 2 years’ experience practising as a Pharmacy Technician/Post-Basic Pharmacist Assistant. ● Knowledge of medical products quality assurance including interpretation, evaluation and analysis of laboratory testing reports and inform decision-making.
 
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 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 of time. *Working knowledge of MS Office. *Valid driver’s licence. *Ethical behaviour and adherence to the SAHPRA code of conduct.
 
DUTIES: ● Ensure that all imported health products for release into the Republic of South Africa possess applicable SAHPRA authorisations, e.g. licence, product authorisation, certificate or permit. ● Stop non-compliant health product shipments from entering the country and ensure that necessary processes are undertaken. ● Collaborate with Border control agencies for the control of health products. ● Refer any deviations that require Regulatory Compliance Management or Inspectorate intervention to the relevant SAHPRA unit. ● Develop, review and ensure implementation of approved Standard Operating Procedures (SOPs) for release/denial of health products at the approved port of entry. ●Work with Port Health and Customs in evaluating, processing and deciding on compliance status and outcome for imported health products. ● Maintaining records by recording and daily filing in the required format of all import related documents. ● All activities must be within approved processes within the Regulatory Compliance Unit and report to the Manager on improvement measures needed monthly. ● Report performance weekly to the allocated Medicines Control Officer: Regulatory Compliance at SAHPRA’s Head Office. ● Submit weekly work plan and output to the Manager: Regulatory Compliance (quantitative and qualitative reports). ● Participate in monthly meetings with Port Health. ●Prepare reports for consideration of your Medicines Control Officer/Supervisor, Unit Manager and Senior Manager.
 
 
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY): Interested applicants who meet the above requirements should forward their applications accompanied by a signed cover letter, clearly reflecting the name of the position and post reference number, attached to a detailed Curriculum Vitae reflecting the names and email addresses of three (3) referees, and certified copies of required qualification/s (matric included), Identity Document (certified within the past three [3] months), 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 a security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment. SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s. SAHPRA complies with the provisions of the Protection of Personal Information Act (POPIA); 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 is 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: Mr I. Mosenyi, Email: itumeleng.mosenyi@sahpra.org.za (APPLICATIONS SENT TO THIS EMAIL ADDRESS WILL NOT BE CONSIDERED FOR THE RECRUITMENT PROCESS). 
 
The closing date is 26 February 2025 at 16:00.
 
 
 
 
 
 

​MEDICINE REGISTRATION OFFICER: PHARMACOVIGILANCE 
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 07/2025 
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 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 applicants who meet the above requirements should forward their applications accompanied by a signed cover 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 might 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 complies with the provisions of the Protection of Personal Information Act (POPIA), 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: 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 21 February 2025 at 16:00.

​MEDICINE REGISTRATION OFFICER: CLINICAL PREREGISTRATION EVALUATION (CONTRACT UNTIL 30 SEPTEMBER 2025) 
SALARY: 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 06/2025 
CENTRE: PRETORIA 
 
REQUIREMENTS: Matric certificate and appropriate 4-year Degree in Pharmacy at NQF level 8 as recognised by SAQA and registration as a Pharmacist with a Professional Body (SAPC) or 4-year science degree in a health science related field at NQF level 8 as recognised by SAQA from a recognized university or tertiary institution. A valid driver’s license. 
 
EXPERIENCE:
At least one-year regulatory experience (post community service). 
 
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/variations: Generate evaluation reports for each new application and submit for peer review in compliance with required template and adopted regulatory /scientific standards (depend on the type of application, i.e., Full/partial reviews Q-BE and Reliance. Evaluation of Type I and II clinical/quality variation applications. Following peer review process, amend the report accordingly to generate a list of queries to the applicant using the correct templates (Full/partial reviews Q-BE and reliance). Peer review other evaluators reports according to the required template and adopted regulatory /scientific standards (Full/partial reviews Q-BE and reliance). Evaluation of PI/PIL applications (new applications and responses). Prepare query or approval or rejection letter to the applicant. Evaluate applicant responses for registration/approval of medicines: Generate second (and subsequent) evaluation report (s) for each response application review. Following 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. Develop and update guidelines, SOPs, and templates: Review existing guidelines, SOPs and templates and update when necessary and provide and attend trainings on guidelines, SOPs and template to new MROs and external evaluators. 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 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: Prepare report for the internal working groups and/or advisory committee and where necessary present at advisory committee for complex scientific matters and ensure adherence to SOPs and Guidelines. Provide quality assurance of reports and facilitate resolutions on technical matters. Align with ICH, WHO, IPRP, international standards, SAHPRA QMS requirements and use the most current SAHPRA templates and guidelines. Timeous execution of recommendations from the advisory committee. Provide technical advice and information to all stakeholders (internally and externally): 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 Chief Regulatory Officer’s office. Technical screening of applications for the registration of medicines: Generate technical screening evaluation report(s) for each application and submit for peer review. Following peer review process amend the technical screening report (s) accordingly to generate a list of queries to the applicant using the correct templates. Peer-review technical screening report (s) done by other reviewers. Prepare screening query / screening rejection letter to the applicant. Provide quality assurance of reports and facilitate resolutions on technical matters. 
 
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 might 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: 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 February 2025 at 16H00