Pharmacovigilance Manager – Integrated Commercial Solutions (ICS)

About the role

The Pharmacovigilance Manager will lead and maintain a compliant pharmacovigilance system across African markets, ensuring patient safety, regulatory compliance and timely adverse event reporting. The role serves as the operational lead for PV activities and supports QPPVs and local PV responsibilities.

Key responsibilities

• Manage and maintain the regional PV system, ensuring compliance with local legislation, GVP guidelines and company procedures, and keep the PSMF up‑to‑date.
• Oversee case management: receipt, triage, review and reporting of ADRs, SAEs, PQC, special situation reports and reconciliation with partners.
• Coordinate risk management activities, including implementation of RMPs and preparation of PSUR/PBRER, DSUR and line listings.
• Ensure regulatory compliance by submitting required PV documentation, acting as primary contact during inspections and handling safety queries.
• Develop and maintain PV SOPs, conduct internal compliance reviews, manage CAPAs and monitor KPIs.
• Oversee vendors and partners, qualify distributors and third‑party safety services, and ensure contractual compliance.
• Design and deliver annual PV training programmes for internal teams and third parties, maintaining training records and competency assessments.
• Collaborate with Regulatory, Medical, Commercial, Quality Assurance, Supply Chain and Marketing to embed patient safety into business activities.

Required profile

• Bachelor of Pharmacy and registration as a Pharmacist.
• Post‑graduate qualification in Pharmacovigilance or Drug Safety (advantage).
• 2‑5 years of experience in the pharmaceutical industry managing PV systems across African regulatory environments.
• Experience with health‑authority inspections, PV databases, electronic safety reporting and SOP/QMS development.
• Strong knowledge of Good Pharmacovigilance Practice, ICH and WHO guidance.
• Demonstrated leadership, accountability, analytical ability and sound judgment.

Required skills

• PV database and electronic safety reporting.
• Good Pharmacovigilance Practice (GVP).
• ICH guidelines.
• WHO pharmacovigilance guidance.
• Risk management and regulatory submission (PSUR, PBRER, DSUR).
• SOP development and quality management systems.