Safety Physician, Associate Director
about 1 month ago
Hamlyn Williams has partnered with a global biopharmaceutical company that is in a big phase of growth and are looking for an experienced Safety Physician at Associate Director level. The European headquarters is in Hesse but the position can be home-based anywhere in Germany.
In this role you function as a safety physician within the global PV medical safety team to bring the European needs and requirements as well as the European perspective on medical aspects and EU healthcare systems to the global team.
The role involves but is not limited to:
- Responsible for Improving and supporting global activities for assigned products by providing medical input and regulatory expertise to risk management plans, risk, minimization activities and aggregate reports.
- Participating in the conduct of pharmacovigilance for assigned products or projects including signal detection, benefit-risk assessment medical assessments and on-going safety evaluation, as part of the global Pharmacovigilance organization.
- Interacting with Agencies such as FDA and EMA, Affiliates, partner companies and service providers.
- Participating in NDA/MAA filings, health authority interactions, and FDA Advisory Committee meetings, as applicable.