Senior Clinical Trial Case Manager

Role: Senior Pharmacovigilance Case Management Expert, overseeing clinical trial safety reporting and compliance. Responsibilities: manage case management activities, ensure adherence to GxP regulations, develop and monitor safety KPIs/KQIs, support audits and inspections, coordinate with vendors for SAE/AESI processing, deliver study-specific training, and oversee PV procedures for timely safety data analysis and reporting. Qualifications: Bachelor's in life sciences (Master's or PhD preferred), 7+ years in multinational PV roles, expert knowledge of global PV regulations and GxP standards, experience with regulatory inspections, complex data management, CAPA, SOP development, and relevant PV software. HighValue: extensive PV expertise within a GxP environment, regulatory inspection experience, global safety compliance, and vendor oversight. WorkSetup: not specified.