Specialist – Biological Medicine (Vaccine) Clinical Assessor X3 at Technology Innovation Agency

Ref No.: SAHPRA 004/2024 

REQUIREMENTS:

• Matric certificate and B. Pharm Degree with master’s degree in pharmacy (NQF level 09) as recognised by SAQA and registration as a Pharmacist with South African Pharmacy Council (SAPC) or / an MBChB degree and registration as a Medical Officer with the Health Professional Council of South Africa (HPCSA). 
• Post graduate qualifications in virology/vaccinology or pharmacology of biotherapeutics and good project management skills is an added advantage. Have experience in biological medicines/vaccines, virology, clinical trials, safety, and efficacy determinations.
•  A minimum of 10 years’ experience in compilation/review of product information and patient information leaflets (Vaccines and biotherapeutics). 
• Knowledge and experience of international guidelines and regulatory standards on biological medicine dossier compilation, Clinical aspects of biological dossier review (independent/expert). 
• Effective training/mentorship skills. 
• Sound knowledge of the Medicines and Related Substances Act 101 of 1965 as amended and all regulations pertaining to the Act. 
• Knowledge of quality, safety, and efficacy aspects of medicines. 

CORE COMPETENCIES AND TECHNICAL PROFICIENCIES: 

• Comprehensive knowledge and understanding of relevant legislation, protocols, standard operating procedures and work instructions. 
• Knowledge of technical aspects for evaluation of Clinical and non-clinical aspects of Biological medicines. 
• Technical and scientific aspects of medicine regulation. 
• Evaluation guidelines as prescribed by the relevant regulatory authorities. 
• Knowledge of international regulatory guidelines as prescribed by the relevant regulatory authorities. 
• Works largely on own initiative and effectively evaluates the most complex assessments. 
• Holds either a more broadly defined or a specialist role within the SAHPRA. Acts as a peer reviewer and mentor for the work of others. 
• Writes and critically evaluates written assessment reports and presentations. 
• Ethical behaviour and adherence to the SAHPRA Code of Conduct. 
• Resolve issues requiring creative and innovative thinking based on the breadth and depth of knowledge and experience. 
• Computer literacy and sound working knowledge of computer software packages. 
• Performance measurement skills. 
• Self-motivated and able to work independently. 
• Ability to manage a variety of cross-functional team members. 
• Competent in problem solving and team building. 
• Information evaluation. 
• Decision making. 
• Objectivity. 
• Resilience. 
• Interpersonal skills. 
• Assertiveness. 
• Customer service. 
• Team management. 
• Can handle challenges that are complex, requiring the application of research and newly assimilated knowledge. 
• Planning and organisational skills. 
• Leadership skills.
•  Coordination skills. Written and verbal communication skills. 
• Diversity management. Time management. Good telephone etiquette. 
• Supervisory skills. 

DUTIES: 

• The job exists for the incumbent to provide: Strategic technical leadership considering local and international reports, interventions, and strategies from other NRAs and WHO. Play an advisory role on SAHPRA regulations, Policies, Standard Operating Procedures (SOPs) and Biological medicines guidelines as adopted by SAHPRA. Liaise with members from the industry to discuss SAHPRA resolutions and requirements of the Medicine and Related Substances Act, No. 101 of 1965 [and medicines quality issues]. 
• Advisory support to key stakeholders, including participation in Regulatory meetings and conferences, external presentations all while demonstrating sound industry and technical knowledge. 
• Technical support in assessment or evaluation of applications for registration of Biological medicines (Biotherapeutics, Biosimilars and Vaccines) to ensure that they are compliant with the Medicines and related substances Act (101 of 1965) as amended and the subscribed guidelines. 
• These assessments specifically pertain to safety and efficacy of new and variation applications and aligned with ICH and SAHPRA guideline requirements. 
• Critical and analytical feedback as peer reviewer and quality assurer of clinical and non-clinical sections of Biological submissions. 
• Training/mentorship on assessment of the Clinical and non-clinical sections of the Biological medicine (Vaccines).