Specialist: Pharmacovigilance at South African Health Products Regulatory Authority

Key Responsibilities include but are not limited to: 

•  Strategic Leadership: Provide technical leadership on pharmacovigilance (PV) strategies informed by local and international reports, interventions, and guidelines from the WHO and other National Regulatory Authorities (NRAs). 
•  Regulatory Decision-Making: Make or recommend regulatory decisions on vaccines and biological products based on comprehensive reviews and assessments. 
•  Signal Detection and Investigation: Conduct signal detection, investigate adverse events, and analyse safety data from diverse sources to support informed decision-making. 
•  Capacity Building: Lead training and development initiatives to enhance pharmacovigilance expertise among SAHPRA staff and stakeholders. 
•  Global Collaboration: Represent SAHPRA in international forums and collaborate with global regulatory bodies to advance pharmacovigilance frameworks and practices. 

Performance Expectation include but are not limited to: 

•  Foster a culture of pharmacovigilance awareness within the organization. 
•  Create and maintain effective pharmacovigilance systems and processes that ensure the timely detection, assessment, understanding, and prevention of adverse drug reactions . 
•  Timely submission of required safety reports to regulatory authorities and other relevant stakeholders. 
•  Develop and deliver training programs that enhance the knowledge and skills of staff, fostering a culture of pharmacovigilance excellence. 
• Utilize advanced signal detection methodologies to proactively identify emerging safety issues.
• Contribute to a robust peer review process that identifies potential safety and efficacy concerns in a timely manner.
• Consistently deliver high-quality, evidence-based clinical assessments that meet deadlines and contribute to well-informed regulatory decisions.
• Collaborate effectively with multidisciplinary teams on PV-related projects.
• Strong analytical and communication skills to interpret safety data and communicate complex information effectively.
• Lead and mentor teams in a dynamic regulatory environment.
• Manage multiple priorities and deadlines efficiently with strong organizational skills.
• Proactively identify areas for improvement within SAHPRA's PV system.
• Conduct thorough reviews and assessments of vaccines and biological products.
• Make informed regulatory decisions on these products based on safety data analysis.
• Provide sound recommendations to support the decision-making process.

Adhere to South African data protection laws and SAHPRA's specific data protection policies

Qualifications and Expertise

Essential:

• MBChB degree with a Master’s in Public Health or Clinical Pharmacology (NQF) Level 09 as evaluated by South African Qualifications Authority (SAQA), with
• Registration with the professional bodies.
• At least 10 years of experience in public health programs or clinical research.
• Active participation in regional or international regulatory associations or advisory bodies

Preferred:

• A PhD in public health or pharmacology.
• Experience in hybrid or remote collaborative work environments