Manager, ICSR Management Team - Job ID: 1982

Role: Manager, ICSR Management Team, responsible for overseeing Individual Case Safety Report (ICSR) processing within Ascendis Pharma's Global Patient Safety organization. Primary objectives include ensuring compliance with regulatory guidelines, maintaining data integrity in safety databases, and supporting safety reporting activities for Ascendis products in rare diseases and oncology. Responsibilities encompass acting as a subject matter expert in safety reporting, managing vendor oversight, triaging adverse event reports, conducting quality reviews, and contributing to process improvements. Collaboration involves liaising with cross-functional teams such as Vendor Management, Study Management, and Medical Science. Requirements: Bachelor's in healthcare, minimum 5 years' recent experience in clinical trial and post-marketing case processing, proficiency with validated safety databases like Argus, MedDRA coding, and knowledge of FDA/EU safety regulations, GVP, and ICH guidelines. High-value details include familiarity with pharmacovigilance (PV) processes, working in a hybrid setting based in Palo Alto, CA, with up to 20% travel, and experience supporting safety activities in rare diseases and oncology. The role emphasizes strong organizational, communication, and team collaboration skills.