Senior Manager, Pharmacovigilance

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