Associate Director, Drug Safety and Pharmacovigilance
Core
Provide strategic and operational leadership for clinical safety activities across assigned programs, ensuring compliant safety oversight and managing end-to-end safety operations.
Role type
Associate Director, Drug Safety and Pharmacovigilance
Builds
Clinical trial safety operations and regulatory reporting for investigational and marketed products
Domain
Biotechnology / Clinical Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global clinical safety regulations knowledge, aggregate safety report preparation (DSURs, PADERs), adverse event review and expedited reporting, SOP development and compliance, safety management plan creation, MedDRA and WHODrug coding, commercial safety database management (Argus, ARIS-G), trial master file management, KPI development and monitoring
Preferred skills
Vendor management, cross-functional collaboration, inspection readiness support, process improvement
Technologies
Argus, ARIS-G, MS Office (Word, Excel, PowerPoint)
Responsibilities
Provide leadership and oversight of external safety vendors; Lead preparation and review of aggregate safety reports; Oversee review and assessment of adverse event reports; Contribute to development and implementation of SOPs; Support inspection readiness activities; Develop and maintain study-specific safety management plans
Seniority
Senior, hands-on IC with strategic oversight
