SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA) VACANCIES

​BORDER MEDICINES CONTROL TECHNICIAN x 2
SALARY LEVEL 07: R434 554.00 – R461 223.00 per annum (Total cost to company)
Ref No.: SAHPRA 09/2025
CENTRE: Durban Harbour and Port Elizabeth 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 two (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 14 March 2025 at 16:00.

​CALL FOR EXPRESSION OF INTEREST
 
CLINICAL TRIALS EXTERNAL EVALUATORS
 
The South African Health Products Regulatory Authority (SAHPRA) hereby invite expression of interest for candidates to serve as External Evaluators for Clinical Trials Evaluation (inclusive of Quality and Clinical safety and efficacy data). 
SAHPRA is a Schedule 3A Public Entity established in terms of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965) to oversee the regulation of medicines, medical devices, and in vitro diagnostics (IVDs) intended for human and animal use; the licensing of manufacturers, wholesalers and distributors of medicines, medical devices and IVDs; and the conduct of clinical trials. 
 
REQUIREMENTS
The External Evaluators are appointed in terms of section 3 (5) of the Medicine’s Act, as amended to assist the Authority in carrying out its functions. These fully qualified external evaluators are crucial to supplementing the skills and experience of the Authority in the area of Clinical Trials. 
Expression of interest is required in the following disciplines: 
• Three (3) external evaluators for Clinical Trials Committee. 
 
Experience and knowledge in the following: 
• Extensive knowledge of Good Clinical Practice, clinical trials legislation, regulations, and global standards. 
• Comprehensive Knowledge of technical aspects for clinical trials evaluation including safety and efficacy of health products. 
• Extensive knowledge and application of the Medicines and Related Substance Act, 101 of 1965 and related regulations 
Sound working knowledge of document management and workflow management software is desired, 
 
Applicable Skills 
• Ability to evaluate scientific evidence on safety and efficacy of medicinal products. 
• Ability to understand the clinical content and knowledge of therapeutic areas under evaluation. 
• Understanding of clinical study design principles and impact on study results. 
• Understanding of the pharmacology of chemicals under evaluation. 
• Ability to interpret results of clinical studies and make clinical practice judgement. 
• Understanding of bio statistical principles of medical research. 
• Strong analytical and communication skills to interpret safety data and communicate complex information effectively. 
• Manage multiple priorities and deadlines efficiently with strong organizational skills. 
• Ability to mentor and lead multidisciplinary teams in dynamic regulatory environments. 
 
 
Duties 
• Review Serious Adverse Events (SAE) reports, progress reports, interim/final study reports and other safety reports during the conduct of Clinical Trials and Bioequivalence studies. 
• Validate the SAE reports on the system after review. 
• Consistently deliver high-quality, evidence-based clinical assessments that meet deadlines and contribute to well-informed regulatory decisions. 
• Utilize advanced signal detection methodologies to proactively identify emerging safety issues. 
• Proactively identify areas for improvement within SAHPRA's safety reporting. Advise on improvement of in safety reporting systems or any other processes in the Unit. 
• Liaise with advisory committee members Clinical Trials Safety Monitoring Committee. 
• Prepare agenda and documentation to serve at the Clinical Trials Safety Monitoring Committee. 
• Present the SAE Reports to Clinical Trials Safety Monitoring Committee / Clinical Trial Committee on critical findings. 
• Support the proceeding of the Clinical Trial monitoring/Expert Committee meetings. Prepare comprehensive minutes and recommendations following the meeting of the Clinical Trials Safety Monitoring Committee. 
• Prepare and communicate the recommendations to the external stakeholder following the Expert Committee meetings. 
• Collaborate effectively with multidisciplinary teams on Clinical Trials-related projects. 
• Update the relevant trackers and align with QMS requirements. 
 
Relevant Qualifications 
• Appropriate degree in medicine (MBCHB) and/or Pharmacy (BPharm) 
• Masters in Health Sciences will be an added advantage 
• At least 5 years of experience in clinical research and Medicine Regulation experience 
 
Hybrid Working Model: Flexibility to work remotely and will be required to work allocated hours per week. 
 
Please take note: candidates need not possess all the above knowledge and skills to express interest. 
 
 
EXCLUSIONS:
Where such person is conflicted in terms of SAHPRA Policy on Management of Conflict of Interest (GOV02). 
is disqualified under the Relevant Act applicable to his or her profession from practising as such. 
- has been found guilty of improper or disgraceful conduct at an inquiry held under ambit of the relevant Act. 
- is a patient as defined in section 1 of the Mental Health Care Act, 2002 (Act No. 17 of 2002). 
- has been convicted of an offence in respect whereof he or she was sentenced to imprisonment without the option of a fine or in the case of fraud. 
- does not meet the minimum requirements. 
 
 
TERM OF OFFICE 
The term of service for external evaluators is two (2) years effective from date of appointment. 
 
PROCEDURE
• A comprehensive CV, qualification/s and a motivation expressing area of expertise must be submitted online at https://apply.sahpra.org.za:6006/
• Only documents in pdf must be uploaded. 
• Further communication will be limited to candidates with appropriate skill sets. 
• Closing date for applications is Thursday, 13 March 2025 at 16h30. No late applications will be accepted. 
 
Enquiries: Ms Mukona Mphidi at mukona.mphidi@sahpra.org.za