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ED / SD, Global Drug Safety & Pharmacovigilance Physician
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- The Drug Safety & Pharmacovigilance Physician role is a safety expert medical role contributing to the global safety strategy and overall safety profile for the assigned products throughout lifecycle.
- Lead, set the strategy and when appropriate write the key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses.
- Apply current regulatory guidance as appropriate for safety surveillance and authorship of safety documents.
- Effectively collaborate with drug safety and cross-functional teams for safety assessment (e.g. review of AEs; safety reports; trial protocols; clinical study reports), ongoing surveillance, and related communication around assigned products.
- Analyze, interpret, and summarize aggregate safety data and communicate these analysis and interpretation to cross-functional teams and senior management.
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