Jobs Available at South African Health Products Regulatory Authority

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.

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.

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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, 

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