- Amgen (Washington, DC)
- …of pharmacovigilance activities and are accountable for the overall safety profile and all product-related decisions and deliverables for assigned products. You ... statistical analysis plans, and clinical study reports + Prepare/review safety sections of new drug applications and other regulatory filings + Serve as … more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …in PV and/or relevant medical field or equivalent of industry experience in drug safety including significant experience with PSURs/ DSURs/(d) RMPS; or in ... The Global Patient Safety (GPS) Lead role (Director of GPS) serves...leading scientific organization, and has a direct impact on drug development, operations, and commercialization in all relevant global… more
- Sanofi Group (Morristown, NJ)
- … strategy and issue escalation with the Therapeutic Area Head (TAH) and Pharmacovigilance (PV) Head + Oversee third-party safety providers during acquisition and ... **Job Title:** Global Safety Officer, Oncology **Location** : Cambridge, MA, Morristown,...of medicine? The race is on to speed up drug discovery and development to find answers for patients… more
- J&J Family of Companies (Horsham, PA)
- …(PV) experience is required. + Working knowledge of medical concepts and familiarity with safety activities in drug development and post marketing and global ... impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Product Safety **Job Sub** **Function:** Product Safety Risk Management **Job… more
- Haleon (Warren, NJ)
- …with a risk-proportionate framework for product vigilance, the **Associate Director, Consumer Safety Science** is accountable for developing the safety strategy ... for medium to high-risk products. The position holder will: + Develop safety strategy for medium to high-risk products within the assigned therapeutic category… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Global Safety Officer **Location** : Cambridge, MA **About the Job** Are you ready to shape the future of medicine? The race is on to speed up drug ... was possible. Ready to get started? **Main Responsibilities:** **Internal & External Safety Expert** + Provide PV and risk management expertise to internal and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …**Summary** The Executive Director, Head of Center of Excellence (CoE), Global Medical Safety will oversee a team of safety physicians and scientists across ... various regions, offering guidance and support to each product safety team in critical areas such as individual case...expectedness of the adverse event in relation to the drug . Ensure all relevant data and findings are incorporated… more
- Bayer (Cambridge, MA)
- …further seamless clinical development. The IPML is responsible for study medical/ safety aspects and risk-benefit assessments supported by Pharmacovigilance and ... the full value chain from pre-D1 up to hand-over to late-stage drug development (following Proof-of-Concept and the decision to enter pivotal studies). The… more
- AbbVie (North Chicago, IL)
- …to support potential product related issues *Key medical quality interface with Pharmacovigilance & Patient Safety (PSEQ), Global Medical Affairs (GMA) and ... drug risk management and/or medical device/ combination product vigilance ( safety signal detection, data mining techniques, pharmacovigilance / device… more
- ThermoFisher Scientific (Austin, TX)
- …required). **Discover Impactful Work:** Advanced leadership responsibilities within the Pharmacovigilance (PV) physician team which may include direct line ... globally to support training and end to end medical monitor and/or safety physician activities and supporting services across the pharmaceutical product life cycle.… more