Senior Manager, Pharmacovigilance

Job Summary

To support ongoing safety surveillance and risk management for respiratory therapeutics, the full-time Senior Manager, Pharmacovigilance will oversee case processing, signal detection, and aggregate safety reporting while ensuring compliance with global pharmacovigilance regulations in a remote setting.

Key responsibilities

• Serve as a pharmacovigilance subject matter expert for ongoing and future clinical trials, including the Phase 3 PHrontier study
• Oversee end-to-end case management for serious adverse events, ensuring accurate intake, triage, and timely regulatory reporting
• Support signal detection and evaluation activities, including periodic review of aggregate safety data and maintenance of risk management plans

Required qualifications

• Bachelor's degree in life sciences, nursing, pharmacy, or related field; advanced degree preferred
• Minimum of approximately 7+ years of pharmacovigilance/drug safety experience in the biotechnology or pharmaceutical industry
• Demonstrated experience with clinical trial safety surveillance and case management
• Working knowledge of global PV regulations and guidance (FDA, EMA, ICH E2 series)
• Experience with safety database systems such as Oracle Argus Safety