REQUIREMENTS:
- A matric certificate and 4-year degree in pharmacy at NQF level 8 as recognised by the South African Qualifications Authority (SAQA). Registration with the South African Pharmacy Council. A relevant master’s degree in pharmacy will be an added advantage.
EXPERIENCE:
- A minimum of three (3) years' relevant post-internship experience.
COMPETENCIES, KNOWLEDGE, AND SKILLS:
- Knowledge and application of the Medicines and Related Substances Act No. 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.
- Demonstrate strong administrative, planning and organising skills.
- Must have good communication skills (verbal and written).
- Must be computer literate (MS Office Suite).
- Pay attention to details.
- Ability to work under pressure and with no supervision.
- Must be able to work in a team, resilient, assertive, innovative and meet deadlines.
- Willingness to work beyond normal working hours where applicable.
DUTIES:
Technical review of clinical trial applications and provide recommendations for approval/rejection of clinical trial applications:
- Screen new applications for clinical trials to ensure adherence to SAHPRA requirements.
- Conduct technical evaluations of applications for clinical trials.
- Recommend applications for review to the Clinical Trials Expert Committee.
- Review responses from applicants and recommend a decision (approval or rejection) of clinical trial applications.
- Communicate the decision (approval or non-approval) or queries to the applicants. Ensure that the status tracker process is finalised or completed timeously for reporting (Finance, performance).
- Manage application cycles for submission of clinical trials.
Technical Review of applications to conduct Bioequivalence studies and provide recommendations for approval/rejection of clinical trial applications:
- Technical screening of new Bioequivalence studies to ensure adherence to SAHPRA requirements. Technical Review of Bioequivalence studies applications.
- Recommend applications to the Clinical Trials Expert Committee where applicable.
- Review applicant responses and recommend for approval or rejection of Bioequivalence studies.
- Communicate the decision (approval or non-approval to the applicants. Ensure that the status tracker process is finalised or completed timeously for reporting. Manage submission of Bioequivalence from receipt to finalisation.
Provide technical support to appropriate Expert Committee/s and SAHPRA in general:
- Allocate clinical trials to the external evaluators in accordance with their expert areas.
- Co-ordinate clinical trials applications and monitor progress of review (follow up with external evaluators).
- Liaise with advisory committee members and external reviewers.
- Prepare agenda and documentation to present at the Clinical Trials Expert Committee.
- Support the proceedings of the Clinical Trial Committee meetings, including the expert consultation meetings.
- Prepare minutes and recommendations following the meeting of the Clinical trials expert committee.
- Communicate the recommendations to the external stakeholder following the Clinical Trials Committee meetings.
Review safety information, progress reports and any other clinical trials correspondence:
- Review Serious Adverse Events (SAE) reports, progress reports and other safety reports during the Conduct of Clinical Trials and Bioequivalence studies.
- Validate the SAE report on the system after review.
- Present the SAE Reports to Clinical Trials Safety Monitoring Committee / Clinical Trial Committee on critical findings.
- Set up systems to implement the process of SAE reporting.
- Advise on improvement of system or any other processes in the Business Unit.
- Liaise with advisory committee members of the Clinical Trials Safety Monitoring Committee.
- Prepare agenda and documentation to present at the Clinical Trials Safety Monitoring Committee.
- Support the proceeding of the Clinical Trial Committee meetings.
- Prepare minutes and recommendations following the meeting of the Clinical Trials Safety Monitoring Committee.
- Communicate the recommendations to the external stakeholder following the Clinical Trials Committee meetings.
Review applications for protocol amendments for clinical trials applications and Bioequivalence studies:
- Screening and technical review of applications for protocol amendments in line with set timelines in annual operations plan.
- Allocation of clinical trials protocol amendment to the external evaluators in accordance with expert areas.
- Advise on improvement of system or any other processes in the Business Unit.
- Check the status of all applications received to monitor timeline in line with Annual Performance Plan (APP) or Annual Operational Plan (AOP).
- Attend and respond to queries and complaints related to applications from external stakeholders in time.
- Update spreadsheet on regular basis.
- Provide statistics on applications reviewed and outstanding in preparation for monthly finance and performance reporting.
Review applications for additional investigators and sites for clinical trials applications and Bioequivalence studies:
- Review investigators, change in investigators/Principal investigators or additional sites in line with the set timelines.
- Check the status of all applications received to monitor timeline in line with the Annual Performance Plan or Annual Operational Plan.
- Attend and respond to queries and complaints related to applications from external stakeholders in time. Provide statistics on applications reviewed and outstanding in preparation for monthly finance and performance reporting.
Develop policies, guidelines as well as standard operating procedures for conducting clinical trial:
- Draft and review existing policies and lead preparation of policy document.
- Develop and review existing Standard Operating Procedures (SOP) and ensure that there are SOPs in place for services offered by SAHPRA.
- Ensures the Business Unit complies with the approved Standard Operating Procedures.
Manage and perform performance assessment of administrative staff and attend to queries addressed to the Clinical Trials Unit:
- Manage administration staff and ensure that the Business Unit meet the deadlines for queries.
- Conduct performance assessment for administration staff in the Business Unit.
Advise and attend to pharmaceutical industry / applicant’s queries or other members of the Public:
- Investigate and advise pharmaceutical industry / applicant’s queries or other members of the public.
- Manage resolution of the queries in your area of work.
- Advise or make recommendations to the Inspectorate and Regulatory Compliance Unit.
- Represent SAHPRA at the local and international events
- Arrange meetings with industry task groups and attend external stakeholder meetings.
Manage the associated risks and audit queries:
- Attend and support internal and external audit meeting and attending to audit queries.
- Manage and keep records of clinical trials.
Closing Date: Friday, 05 August 2026
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