The South African Health Products Regulatory Authority (SAHPRA), is the National Medicines Regulatory Authority established in terms of the Medicines and Related Substances Act, 1965, (Act No. 101 of 1965) as amended, to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances, clinical trials and medical devices, and related matters in the public interest.
MEDICINE REGISTRATION OFFICER: SECTION 21 UNIT
CLINICAL EVALUATION MANAGEMENT x 1
Salary: (R788 910.00 – R837 326.00) TOTAL COST TO COMPANY
Ref No.: SAHPRA 048/2023
CENTRE: Pretoria
REQUIREMENTS: ● Appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) – proof of current registration as a Pharmacist to accompany the application). A postgraduate qualification in pharmacology or
equivalent degree is a strong recommendation. Experience: ● 8 years or more experience in the hospital setting or clinical research setting (post community service).
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES: *Sound and in-depth knowledge of the Medicines and Related Substances Act 101, 1965 as amended and the regulations pertaining to the Act. *Sound knowledge of regulatory scientific and technical requirement (in terms of quality, safety and efficacy aspect). *Good knowledge of the regulatory requirements of the use of an unregistered medicine, i.e., Section 21 of the Medicines Act and Regulation 29 of the General Medicines Regulations. *A solid understanding of application procedures. *Section 21 application technical evaluation skills. *Planning and organising skills. *Performance measurement skills. *Self-motivated and able to work independently. *Team management. *Competent in problem solving and team building. *Decision making. *Objectivity. *Prepared to travel and work irregular hours. *Drive and self-management skills. *Resilience. *Communication skills (verbal, written, negotiation, conflict management, presentation). *Interpersonal skills. *Assertiveness. *Ethical behaviour. *Customer service. *Knowledge of MS Office. *A valid driver’s license.
DUTIES & RESPONSIBILITIES:
OUTPUT 1:
- Technical screening of section 21 applications.
- Evaluation of Section 21 applications based on review of data from multiple sources.
- Research Section 21 applications for new unregistered medicines.
- Liaise with experts (internal and external) on high-priority applications.
- Attend to and review written Section 21 queries, e.g. procedural, new products, monitor
Section 21 email inbox. - Compile Section 21 agenda documents for presentation at Clinical Trials Committee
meeting or SAHPRA internal discussions. - Prepare minutes of the CTC meeting pertaining to Section 21 resolutions.
- Prepare letter/s to relevant stakeholders communicating CTC meeting resolutions or
expert discussion on Section 21 issues. - Liaise with experts on high-priority applications.
OUTPUT 2:
- Conduct monitoring and evaluation of the unit’s activities as per Annual performance
Plan, Operational Plan, revenue-generating requirements and risk register entries on
a monthly and quarterly basis. - Draft policy documents as pertains to section 21 authorizations (SOPs, guidelines,
legislation amendments). - Contribute to optimal submission of proof of payment source document (section 21
applications) to the Finance unit.
OUTPUT 3:
- Supervise admin staff in the Section 21 unit.
- Play an active role with stakeholder engagement, awareness and outreach programs
(e.g., applicants, pharmaceutical industry, NDoH, etc.).
INSTRUCTIONS TO APPLICANTS: All applications must:
- Be submitted with a covering letter clearly reflecting the name of the position and
post reference number, be signed, accompanied by a comprehensive CV, the names
and email addresses of 3 referees 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. - Applications must be submitted by email to recruitment@sahpra.org.za, including
the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO
THIS ADDRESS. - 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.
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.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND
APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: 26 September 2023 at 16H00.