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Support the Head of Global Ops, Regions & QM and Regional PV Leads in the oversight, harmonization and maintenance of Regional PV activities, processes and deliverables. Contribute to the establishment and maintenance of the applicable pharmacovigilance
Contribute to the development of the audit strategy & program and plans related to the GVP area-PV processes, vendors, Partners and affiliates; Act as a GVP Audit Program Owner when delegated by Global Quality GCP/GVP Head; Perform and coordinate PV
Takes responsibility for oversight and monitoring of the system for collection, processing, reconciliation, and reporting of ICSRs for the DSE region. This includes ensuring ICSR report intake, case processing, workflow monitoring, follow-up requests,
Lead the multidisciplinary Clinical Team at development-program level, providing scientific direction, strategic alignment and accountability across the program. Shape innovative clinical development strategies that maximize the compound's value