Manager, Global Pharmacovigilance and Risk Management (Woman / Man)

Location

Poland: Warsaw office hybrid / remote. Additionally available in Serbia, Bulgaria, Hungary, Romania.

Key Accountabilities

• Independently conduct signal detection and analysis activities, ensuring that safety signals are appropriately managed and tracked. Identify potential signals, validate and prepare signal assessment reports, or other related documents. Contribute to analyses in external databases (e.g. EVDAS) using data mining methods for detection and evaluation of safety signals.
• Provide medical expertise during CCSI/CCDS, RMPs/REMS, aggregate reports and DSURs creation.
• Prepare Health Hazard Evaluations (HHE's) and create respective documents in close cooperation with involved departments.
• Prepare responses to ad-hoc requests from regulatory agencies.
• Maintain pharmacovigilance expertise, understanding international...