Clinical Trials External Evaluators at South African Health Products Regulatory Authority

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