Director, ICSR Management Team - Job ID: 2018

Role: Senior leader overseeing Pharmacovigilance (PV) case management at Ascendis Pharma, reporting to the Head of Global PV Operations. Objectives: Ensure compliance, data integrity, and strategic oversight of ICSR activities across global safety operations. Responsibilities: Manage a team of ICSR Management Leads, oversee ICSR processing, vendor performance, and safety data quality; develop PV policies, SOPs, and training; collaborate on process improvements, signal detection, and risk management; ensure regulatory compliance and support inspections. Qualifications: Healthcare professional degree (B Pharm, PharmD, RN) with at least 10 years' PV experience, including 5+ years in leadership; expertise in FDA, ICH guidelines, global safety regulations; proficient with validated safety databases (Argus preferred), MedDRA coding; strong strategic, communication, and organizational skills. High-Value: Focus on pharmacovigilance for biopharmaceutical products within endocrinology, rare disease, or oncology in a fast-paced, global environment. Involves vendor oversight, cross-functional collaboration, and regulatory inspection readiness. WorkSetup: Remote with up to 20% travel domestically and internationally.