Pharmacovigilance Specialist

Join Abacus Medicine Group in a senior pharmacovigilance role as Deputy QPPV. Support the Qualified Person for Pharmacovigilance in maintaining oversight of the pharmacovigilance system. Ensure compliance with EU legislation and Good Pharmacovigilance Practices for medicinal products where the company acts as MAH.

Act as delegate to the QPPV during absences, serving as key point of contact for health authorities like the EMA. Oversee pharmacovigilance activities for internal teams, external partners, commercial partnerships, parallel distribution, and parallel import. Maintain an inspection-ready Pharmacovigilance System Master File and robust processes for adverse event collection, assessment, and reporting.

Contribute to signal detection, Risk Management Plans, PV audits, inspections, and CAPA follow-up. Monitor compliance through KPIs and quality metrics. Support PV oversight for partner products, safety data exchange agreements, and reconciliation activities.

Operate in a highly regulated environment with system ownership, partner management, and regulatory accountability across Europe. Bring strong pharmacovigilance experience at system level with understanding of regulatory requirements and partner setups. Play a key role in patient safety and continuous improvement of the PV system.