Pharmacovigilance Senior Officer

About the role

We are seeking a Pharmacovigilance Senior Officer to join our Medical team. The role involves overseeing PV activities across assigned markets and partners, ensuring compliance with local regulations, safety agreements, and company standards while safeguarding patient safety and data integrity.

Key responsibilities

• Process and report adverse events to principals and Health Authorities in a timely and accurate manner.
• Coordinate submission and follow‑up of aggregate safety reports and other PV documentation.
• Manage reconciliation activities with principals, sub‑distributors, and third parties.
• Respond to PV inquiries from principals and Health Authorities.
• Support preparation and management of Risk Management Plans and related submissions.
• Act as primary contact during PV audits and inspections; develop and follow‑up CAPA plans.
• Organise and deliver PV training sessions for internal staff and external partners.
• Maintain PV databases, trackers, SOPs, PSMF, PSSF and other documentation.

Required profile

• Proven experience in pharmacovigilance operations, preferably at a senior level.
• Strong knowledge of local PV regulations and international safety standards.
• Excellent analytical and problem‑solving abilities.
• Ability to communicate clearly with principals, Health Authorities and internal stakeholders.

Required skills

What we offer

• Opportunity to work within a dynamic medical team.
• Exposure to multi‑market PV activities and regulatory interactions.
• Professional development in risk management and compliance.