- Lead Safety Management in Global Clinical Trials
- Opportunity to Contribute to Clinical and Post-Marketing Studies
About Our Client
- European pharmaceutical company with development pipeline across crucial therapeutic areas, including immunology, oncology, cardiovascular and internal medicine
The Successful Applicant
Monitor the benefit risk profile of assigned portfolio in an ongoing fashion by organizing PVPT and providing evaluation to Safety review Meeting (SRM) and by chairing the local Safety Management Team (SMT).
Ensure effective and timely delivery of safety-related documents, such as PHV part of NDA dossier, replies to Health Authority (HA) inquiries, RMP, Proper Use Guide, EPPV report, JPSUR and emergency letter.
Drive strategic preparation for the NDA filing/approval/launch of products in charge by fostering team spirits among PVPT and local SMT
Communicate in a timely, transparent and proactive manner with GPV functions about local RMP/Risk Monitoring and Risk Minimization
Activities including update of Global Tracking Too
What's on Offer
- Opportunity to work on global studies
- Contribute to PMS and clinical studies