Senior Specialist Pharmacovigilance (Maternity Leave Cover)

About the role

The Senior Specialist Pharmacovigilance will lead local PV activities, ensuring compliance with all applicable regulations, company policies and procedures. This maternity‑leave cover position works across one or more countries, collaborating with internal functions and external partners to safeguard patient safety and deliver high‑quality safety data.

Key responsibilities

• Execute local pharmacovigilance processes, aligning activities with local legislation and global procedures.
• Support management and negotiation of local PV agreements and implement Post‑Approval Safety Monitoring Programs.
• Coordinate aggregate safety report submissions and deliver local PV training.
• Manage day‑to‑day adverse event case processing, including intake, translation, acknowledgment, follow‑up and regulatory submission.
• Assist with audits, inspections and CAPA development, and contribute to business continuity plans.
• Develop and maintain local PV procedures, SOPs, training materials and controlled documents, ensuring proper translation and quality control.
• Prepare, maintain and submit local Risk Management Plans, oversee risk minimisation measures and conduct literature screening.
• Monitor health‑authority websites for safety alerts and emerging issues, and liaise with local business units on safety updates.

Required profile

• Proven ability to independently execute local PV activities and ensure regulatory compliance.
• Experience acting as back‑up Qualified Person for Pharmacovigilance (QPPV) or local PV contact.
• Strong background in adverse event case management and PV documentation.
• Familiarity with audit, inspection readiness and corrective‑action processes.
• Capability to develop and maintain PV procedures, SOPs and training materials.
• Experience with risk management, literature screening and monitoring of health‑authority communications.

Required skills