Senior Manager Drug Safety/Pharmacovigilance

Job Purpose

This hybrid role is responsible for managing drug safety vendor oversight and safety operational activities, as well as contributing to safety surveillance for MoonLake products in clinical development. The individual will collaborate cross-functionally and work with external safety teams, ensuring adherence to global pharmacovigilance & GCP regulations, and ensuring inspection readiness.

Major Accountabilities

PV Operations & Vendor Oversight

• Setup/update Safety Management Plans (SMPs) & monitor safety vendor deliverables including ICSR and periodic report compliance.
• Maintain and monitor the quality of outsourced PV activities; ensure the activities are compliant with GVP, GCP and global regulatory requirements.
• Monitor KPI compliance of the vendor for the outsourced activities.
• In collaboration with safety vendor and internal/external Data Management groups, perform/oversee TMF filing/SAE reconciliat...