Senior Specialist Pharmacovigilance

Are you experienced in Pharmacovigilance and eager to contribute to the safety of medicines worldwide? In this role, you will be responsible for executing and improving PV processes, ensuring compliance, and supporting audits, inspections, and safety reporting.

Responsibilities include: executing and coordinating local Pharmacovigilance (PV) activities, ensuring compliance with legislation, regulations, and internal procedures; processing, following up on, and reporting adverse event notifications in accordance with applicable PV guidelines; supporting PV audits, inspections, and compliance activities, including drafting and following up on CAPAs; preparing, maintaining, and improving PV procedures, SOPs, training materials, and other controlled documents; managing Risk Management Plans (RMPs), safety measures, and literature screening; monitoring the quality, archiving, and documentation of safety-related data; advising internal stakeholders on PV regulations, processes, and compliance matters; collaborating with health authorities, business units, external partners, and vendors; representing Pharmacovigilance in cross-functional projects and governance structures; supporting the PV Lead and acting as backup during absences.

What we expect from you: a Bachelor's or Master's degree in Life Sciences, Pharmacy, Health Sciences or similar; at least 2 years of experience within the pharmaceutical industry in a similar role; experience with Pharmacovigilance, Drug Safety or medication safety; knowledge of PV regulations, adverse event reporting, and quality management systems; strong communication skills in Dutch and English; independent, proactive, and precise work attitude.

TMC is an international high-tech consultancy company that leverages expertise to support its clients in addressing their technological challenges. As an Employeneur, you become part of the TMC family, with a challenging and stimulating work environment.