Head of Pharmacovigilance & Drug Safety

Placements24; Cape Town; On-site; ZAR 1,000,000 - 1,600,000; Full time

Job summary

Placements24 is seeking an experienced Lead Pharmacovigilance Specialist to join their Cape Town team. This pivotal role oversees drug safety surveillance, developing PV strategies and leading a dedicated team to ensure patient safety and regulatory compliance.

The ideal candidate has a strong track record in PV management, global regulatory knowledge (FDA/EMA CIOMS), and the ability to drive continuous improvement within a biopharmaceutical setting in South Africa.

Qualifications

• Master's degree or higher in health science, pharmacy, or related field.
• 7+ years in pharmacovigilance within pharmaceutical/biotech industry.
• Demonstrated leadership of a PV team.
• Strong knowledge of global PV regulations (FDA/EMA/CIOMS).

Responsibilities

• Lead and manage the pharmacovigilance team with guidance, training, and performance evaluations.
• Develop, implement, and maintain pharmacovigilance policies, procedures, and systems.
• Oversee collection, assessment, and reporting of AE and SAE data.
• Ensure compliance with global regulatory requirements including GVP modules.
• Prepare and submit aggregate safety reports (DSURs, PADERs) to authorities.
• Conduct signal detection and risk assessment activities to identify safety issues.
• Manage safety data exchange agreements with third-party partners.
• Serve as the primary PV contact for regulatory health authorities.
• Contribute to safety sections of regulatory submissions (IND, NDA, MAA).
• Conduct periodic audits of PV processes and systems to ensure quality and compliance.

Skills

Leadership

Analytical thinking

Pharmacovigilance knowledge

Regulatory knowledge

Communication skills

English proficiency

Education

Master's degree in health science/pharmacy

Tools

Argus

ARISg

Job description

Placements24 is seeking an experienced Lead Pharmacovigilance Specialist to join their Cape Town team. This pivotal role oversees drug safety surveillance, developing PV strategies and leading a dedicated team to ensure patient safety and regulatory compliance.

The ideal candidate has a strong track record in PV management, global regulatory knowledge (FDA/EMA CIOMS), and the ability to drive continuous improvement within a biopharmaceutical setting in South Africa.