Associate Director, Pharmacovigilance Scientist

Position Summary: The Associate Director, Pharmacovigilance Scientist supports safety evaluation and pharmacovigilance activities for all products across clinical development and, as applicable, post-marketing readiness. Partners cross-functionally to detect, assess, understand, document, and prevent product safety risks. Essential Responsibilities: Perform sponsor review and approval of serious adverse event (SAE) and other individual case safety reports in Argus (completeness, medical consistency, queries, coding, narrative quality, causality, expectedness, reportability, and follow-up). Author/contribute to safety topic reviews, signal evaluations, aggregate safety analyses, benefit-risk assessments, and safety summaries for governance and regulatory documents (e.g., Investigator Brochure updates, DSURs, clinical study reports). Implement and continuously improve signal management (detection, tracking, validation, prioritization, assessment, escalation, documentation, inspection‑ready records). Review safety data from trials, safety/clinical databases, literature, and nonclinical sources to identify emerging concerns and changes in known risks. Support protocol development/amendments, safety monitoring plans, and safety sections of study documents. Contribute to SAE reconciliation, safety data meetings, Safety Management/Governance Team activities, and Data Monitoring Committee support. Maintain Reference Safety Information, expectedness criteria, terms of special interest, and product risk language. Collaborate with PV vendors/CROs for quality case processing, query resolution, safety database documentation, compliance, and oversight of delegated PV activities. Provide PV input to regulatory responses, inspections readiness, SOPs/work instructions, vendor oversight plans, training, and process improvements. Maintain knowledge of global PV regulations, ICH guidance, FDA/EU expectations, oncology safety considerations, MedDRA, and best practices. Minimum Education: Advanced degree in a health/life sciences discipline preferred (e.g., PharmD, MSN/NP, MPH). Bachelor’s may be considered with significant relevant experience. Experience & Qualifications: Typically 8+ years in pharmacovigilance/clinical safety/drug safety science/clinical development (oncology and/or gene‑mediated therapy preferred). Strong knowledge of global PV requirements (ICH GCP, ICH E2, FDA IND safety reporting, EU clinical trial safety reporting, Good Pharmacovigilance Practice). Hands‑on safety database experience, preferably Argus. Ability to review complex safety/clinical data and produce clear written safety assessments. Experience supporting protocol/investigator brochure/DSURs/clinical reports/safety monitoring plans/signal assessments and regulatory responses. Knowledge of signal detection/management practices. Excellent written/verbal communication; strong organizational skills; collaborative, proactive, accountable style. #J-18808-Ljbffr