Medical Director, Pharmacovigilance

Position Purpose Medical review of adverse event data, development of company causality assessment frameworks in post‑marketing surveillance, and leading signal detection and management activities (reports to Head of Pharmacovigilance). Key Responsibilities Lead medical review of individual case safety reports (ICSRs), including SAEs and AECIs; oversee vendor/contractor medical review. Develop and implement company causality framework for clinical trial and postmarketing AE data. Build and oversee inspection‑ready ICSR review workflows and business practices. Oversee MedDRA coding for postmarketing ICSDRs and develop product‑specific coding guidelines. Lead signal detection/management, including product‑specific signal detection plans. Refine signal detection methodologies (data sources, disproportionality analysis) appropriate to postmarketing. Present signal assessments with benefit‑risk contextualization; maintain signal tracking/disposition. Chair internal safety review committee (ISRC) and recommend risk classification/mitigation to the Executive Safety Committee. Contribute medical narrative and clinical interpretation for DSUR/PSUR/PBRER and NDA/MAA safety summaries; provide input to Core Safety Information and labeling. Support regulatory agency interactions; contribute to protocols, informed consent, investigator brochure, and reference safety information. Collaborate with PV leadership on medical/PV capability building, vendor oversight, and safety database governance; support staffing/hiring and represent medical safety across functions. Required/Preferred Skills & Experience MD or equivalent; clinical training in neurology/pediatric neurology/pediatrics preferred. 5+ years industry pharmacovigilance experience. Postmarketing drug safety experience with commercial‑stage AE management and signal detection. Experience in signal detection/management using clinical judgment; aggregate safety report contribution (NDA/MAA) preferred. Compensation & Benefits Anticipated salary: $279,000–$332,000; annual bonus and equity participation. Medical/dental/vision; life and disability insurance; paid parental leave; 401K match; unlimited vacation; tuition assistance; ESPP. Application Instructions Apply via Stoke’s Career Center: #J-18808-Ljbffr