Pharmacovigilance Specialist

A global pharmaceutical organization focused on patient safety, regulatory compliance, and the continuous monitoring of drug and device safety across international markets. The company operates within a highly regulated environment and is committed to maintaining the highest standards of pharmacovigilance and risk management to support patient wellbeing worldwide. The Senior Specialist, Pharmacovigilance is responsible for managing and executing local pharmacovigilance activities while ensuring compliance with regional and global regulations.

This role supports safety surveillance processes, adverse event management, regulatory submissions, audits, inspections, and risk management activities. The position also serves as a key liaison between internal stakeholders, external partners, and health authorities to maintain high quality safety oversight.

Responsibilities include: manage local pharmacovigilance (PV) activities in compliance with local regulations and global procedures; handle adverse event (AE) case management, including intake, follow-ups, translations, safety assessments and regulatory submissions; manage PV agreements, due diligence, safety monitoring programmes and aggregate reports; support PV audits, health authority inspections, self-inspections, CAPA and compliance activities; develop and maintain SOPs, PV procedures, training materials, Risk Management Plans (RMPs) and controlled documentation; monitor drug safety signals, local literature, health authority updates and risk minimisation measures, while coordinating with internal and external stakeholders.

Requirements: Degree in Life Sciences, Health Sciences, Pharmacy, Biotechnology, Medical Sciences or a related field; Minimum 2 years of pharmaceutical industry experience, preferably in pharmacovigilance; Strong knowledge of adverse event reporting, global PV regulations and local regulatory requirements; Experience with PV Quality Management Systems, audits, inspections, CAPA and compliance management; Understanding of Risk Management Plans, safety monitoring, risk minimisation measures and safety reporting; Fluent English communication skills, with strong stakeholder management, documentation, presentation and project management abilities.

Experience developing SOPs/training materials is important.