Specialist, Pharmacovigilance
Abacus Medicine Group · Alkmaar, North Holland, THE NETHERLANDS
Do you want to play a key role in ensuring patient safety and regulatory compliance across Europe? Join us in a senior pharmacovigilance role where you will...
Job description
Do you want to play a key role in ensuring patient safety and regulatory compliance across Europe? Join us in a senior pharmacovigilance role where you will help shape and oversee our PV system – and step in as a key decision-maker when it matters. The opportunity: As our Deputy QPPV, you will support the Qualified Person for Pharmacovigilance (QPPV) in maintaining oversight of our pharmacovigilance system and ensuring compliance with EU legislation and Good Pharmacovigilance Practices (GVP) for the medicinal products for which the company acts as the marketing authorization holder (MAH). You will also contribute to oversight of products managed through commercial partnership, and parallel distribution and parallel import (PD/PI). This role combines system ownership, partner oversight/management, and regulatory accountability in a highly regulated environment. When needed, you will act as a delegate to the QPPV for the categories mentioned above, ensuring continuity of oversight and serving as a key point of contact for health authorities such as the European Medicines Agency (EMA). We would like you to: Act as deputy QPPV and step in during absences, taking on delegated responsibi...