- Takeda Pharmaceuticals (Boston, MA)
- … Pharmacovigilance Scientist with the following duties: Facilitate ongoing safety surveillance for assigned products, assisting with data collection and ... Signal Evaluation Reports, and Health Authority responses; Contribute to safety -related deliverables associated with new drug applications, benefit-risk… more
- Takeda Pharmaceuticals (Boston, MA)
- …Company-wide patient safety expert for assigned pharmaceutical / biological / drug -device combined products, accountable for the safety strategy and major ... and develop risk management plans including risk minimization measures to address specific safety concerns related to the drug in development or a product… more
- Amgen (Washington, DC)
- …us and transform the lives of patients while transforming your career. **Global Pharmacovigilance (PV) Scientist** **What you will do** Let's do this. Let's change ... this vital role you will work with the Therapeutic Safety Teams for safety assessment activities for...guidance of GSO + Support activities related to new drug applications and other regulatory filings + Assist GSO/… more
- Sumitomo Pharma (Raleigh, NC)
- …English. **Education and Experience** + **Medical Degree (MD) with 3-5 years of drug safety experience in a pharmaceutical company** + Experience in oncology ... Evaluation and Mitigation Strategy (REMS) + Contributes to PVRM and cross-functional drug development teams and manages Safety Charters + Handles Health… more
- Amgen (Washington, DC)
- …Analytics Center (DAC). Observational research (OR) makes important contributions to drug development, commercialization, and safety evaluation. OR gives ... products. + Designs and implements retrospective database studies in support of safety and pharmacovigilance . + Provides epidemiological input to worldwide… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …Proven track record of leadership and strategic management, team development in pharmacovigilance . + Strong understanding of drug development processes and ... President (VP) of GPS Operations is responsible for overseeing the global pharmacovigilance areas of Case Evaluation and Reporting (CER), Quality and Compliance… more
- Boehringer Ingelheim (Ridgefield, CT)
- …review of team output. + Provide updates of the assigned drug 's safety profile to senior management and recommend pharmacovigilance / risk management ... and expert team of physicians in the global Oncology Therapeutic Area of Patient Safety and Pharmacovigilance at BI, whose priority is the wellbeing of our… more
- Lilly (Indianapolis, IN)
- …Through a deep technical knowledge of the regulatory framework across Pharmacovigilance , Regulatory, Medical, and Product Quality functions, and the design and ... broad network/functional impact: + Lead and conduct risk assessments of Pharmacovigilance , Regulatory, Medical, and Product Quality functions for the generation of… more
- United Therapeutics (Research Triangle Park, NC)
- …across functions. This role is responsible for management of Global Product Safety & Pharmacovigilance business alliance activities and contribution to AA&C ... an option. **Who You Are** Do you have a deep understanding of pharmacovigilance (PV) regulations globally and their operational implications for a wide range of… more
- Amgen (Washington, DC)
- …lead the execution of clinical pharmacology studies including bioequivalence, special safety , food-effect, drug - drug interaction, special population, ethnic ... Doctorate degree (PhD or DNP) OR PharmD OR MD and 2 years of Safety / Pharmacovigilance or Clinical Research experience in a hospital, university or clinical… more