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Associate Director Senior Patient Safety Scientist
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Full-time
- This is an opportunity to further develop your pharmacovigilance (PV) experience in safety programs, spanning the entire life cycle of drug development and pre or post submission.
- We are looking for an Associate Director, Senior Patient Safety (PS) Scientist to join our Patient Safety department, working in the Patient Safety Biopharma Therapeutic Area. In this exciting and challenging role, you will work collaboratively with the Global Safety Physician (GSP) and other PV Scientists and physicians.
- Leads the collaboration with GSP and Clinical representatives and authors the Reference Safety Information (RSI) for multiple or complex development products.
- Authors/provides strategic leadership to regulatory submissions for new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts.
- Leads and/or conducts proactive pharmacovigilance and risk management planning for complex products, including preparation of the safety aspects of Global Risk Management Plans and Risk Evaluation and Mitigation Strategies (REMS) in partnership with the GSP and others as appropriate.
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