The Senior Pharmacovigilance Specialist is responsible for the day-to-day case management activities within the country(ies) covered by the country operation (i.e. The Netherlands), including compliance with PV processes and regulations and our policies and procedures and is able to function independently in the processing of adverse events. In the absence of the PV Country Lead, he/she is responsible for overseeing and managing the day-to-day activities of the local country operations Pharmacovigilance Department.
Procedural responsibilities include the areas of: Adverse experience case management, including HA submissions; aggregate safety report health authority submissions and health authority submission compliance for individual case safety reports and aggregate safety reports.
The Senior Pharmacovigilance Specialist acts as backup for the PV Country Lead and, as requested by the PV Country Lead, the Senior Pharmacovigilance Specialist may undertake other additional activities including projects.
What we offer:
Research & Development Division
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.