Lead Pharmacovigilance Specialist: Leadership & Safety

Placements24; Randburg; Hybride; ZAR 1 000 000 - 1 500 000; Plein temps

Avantages offerts par ce poste

Competitive salary package

Annual bonus based on performance

Medical, pension, and life cover

Generous leave and sick leave

Professional development opportunities

Dynamic Randburg-based workplace

Résumé du poste

Placements24 is seeking an experienced Lead Pharmacovigilance Specialist in Randburg, Gauteng. You will lead a PV team, manage safety databases, and ensure compliance with global regulations for our pharmaceutical products.

You will oversee adverse event data collection, signal detection, and PSUR submissions, while training junior staff and coordinating with authorities and healthcare professionals.

Qualifications

• Bachelor's degree in Pharmacy, Medicine, Nursing, or a related life science field.
• Master's degree is preferred.
• Minimum 7 years in pharmacovigilance with at least 2 years in a lead/supervisory role.
• Solid knowledge of global PV regulations (ICH E2, GVP).
• Experience with PV databases such as Argus/ARISg.

Responsabilités

• Lead and manage PV activities for assigned products in line with regulations.
• Oversee collection, assessment and reporting of adverse events from multiple sources.
• Manage PV database ensuring data integrity and accuracy.
• Conduct signal detection and risk assessment activities.
• Prepare PSURs and other regulatory safety reports.
• Develop and implement PV SOPs and work instructions.
• Train and mentor junior PV staff.
• Liaise with regulators, HCPs, and internal departments on safety matters.
• Ensure PV activities meet global standards and participate in audits.

Connaissances

Pharmacovigilance leadership

Regulatory compliance

PSUR reporting

Data analysis

Team management

Formation

Bachelor's in Pharmacy/Medicine/Nursing

Master's degree preferred

Outils

Argus

ARISg

Description du poste

Placements24 is seeking an experienced Lead Pharmacovigilance Specialist in Randburg, Gauteng. You will lead a PV team, manage safety databases, and ensure compliance with global regulations for our pharmaceutical products.

You will oversee adverse event data collection, signal detection, and PSUR submissions, while training junior staff and coordinating with authorities and healthcare professionals.