Senior Manager, Pharmacovigilance

PharmD or RN degree required. Experience in pharmacovigilance or in clinical development within biotech or pharmaceutical industry. Proven experience reviewing adverse events and working closely with safety physicians. Hands-on experience supporting DSMBs and SRCs and preparing safety deliverables. Proficiency in Microsoft Office Suite and Microsoft Teams. Strong knowledge of global PV regulations (FDA, EMA, ICH guidelines). Excellent analytical, organizational, and communication skills. Ability to thrive in a fast-paced, start-up environment. Fluency with Argus safety database. Familiarity with rare disease or oncology programs. Prior experience in a start-up or small biotech setting.

Oversee pharmacovigilance activities for assigned clinical programs. Review and evaluate adverse event (AE) reports, including serious adverse events (SAEs). Ensure quality and accuracy of safety data review. Manage and oversee the scheduling, planning, and facilitation of DSMB and SRC meetings. Contribute strategically to the preparation of aggregate safety reports. Partner with safety physicians on signal detection, risk assessments, and benefit-risk evaluations. Ensure organizational compliance with global pharmacovigilance regulations. Manage pharmacovigilance-related quality events, including change controls, deviations, and CAPAs.