- Sanofi Group (Morristown, NJ)
- …and pharmacovigilance agreements **Impact:** + Ongoing assessment of the safety status of the product + Review, preparation, contribution and/or approval of ... **Job Title:** Global Safety Officer, I&I **Location:** Morristown, NJ Cambridge, MA...of medicine? The race is on to speed up drug discovery and development to find answers for patients… more
- AbbVie (North Chicago, IL)
- …toxicology to effectively conduct safety surveillance 2. Responsible for safety surveillance for pharmaceutical / biological / drug -device combined ... pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses, aggregate reports. 4. Apply current regulatory… more
- AbbVie (North Chicago, IL)
- …signal detection, validation and assessment). Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Experts on ... toxicology to effectively conduct safety surveillance + Responsible for safety surveillance for pharmaceutical / biological / drug -device combined… more
- AbbVie (North Chicago, IL)
- …and evaluation, risk management, etc.). Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Responsibilities: * ... toxicology to effectively conduct safety surveillance. * Responsible for safety surveillance for pharmaceutical / biological / drug -device combination… more
- Sanofi Group (Morristown, NJ)
- …Your skills could be critical in helping our teams accelerate progress. The Patient Safety & Pharmacovigilance (PSPV) aspiration is to be a cutting-age safety ... of medicine? The race is on to speed up drug discovery and development to find answers for patients...process, method and technology experts dedicated to supporting Global Safety Officer (GSO) and Pharmacovigilance Scientists (PVS)… more
- Takeda Pharmaceuticals (Boston, MA)
- …Affairs, Regulatory Affairs, Biostats) to ensure alignment of global position for pharmacovigilance risk management processes to maximize patient safety + ... strategic expertise to cross-functional product team members in developing pharmacovigilance risk strategies including benchmarking and scenario planning. + Support… more
- 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
- AbbVie (South San Francisco, CA)
- … safety . + Potentially represent SSG/DSS on external initiatives to advance the drug safety analytics discipline (eg, ASA, PhUSE, DIA, etc.), depending on ... Statisticians are part of collaborative, cross functional teams including members from Pharmacovigilance and Patient Safety (eg, product safety team… more
- Amgen (Washington, DC)
- …input to protocols, statistical analysis plans, and clinical study reports + Prepare/review safety sections of new drug applications and other regulatory filings ... us and transform the lives of patients while transforming your career. **Global Safety Medical Director - Hematology/Oncology** **What you will do** Let's do this.… more