Job Description

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.

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