- Amgen (Washington, DC)
- …team. Join us and transform the lives of patients while transforming your career. ** Global Pharmacovigilance ( PV ) Senior Scientist** **What you will ... will also provide scientific and compliance expertise as needed to Global Patient Safety. Applicable tasks may vary by product(s) assigned. **Responsibilities**… more
- Amgen (Washington, DC)
- …team. Join us and transform the lives of patients while transforming your career. ** Global Pharmacovigilance ( PV ) Scientist** **What you will do** Let's do ... in Safety Governance per Amgen processes + Prepare presentation of the Global Safety Team's recommendations on safety issues to the cross-functional decision-making… more
- Takeda Pharmaceuticals (Boston, MA)
- …contribute:** + Technically fully competent to perform all usual Principal Pharmacovigilance Scientist/ Senior Pharmacovigilance Scientist workload, including ... life-changing therapies to patients worldwide. Join Takeda as a ** Senior ** **Principal Pharmacovigilance Scientist in the Inflammation...other relevant functional areas both within and outside of global PV to best ensure the most… more
- AbbVie (North Chicago, IL)
- …of pharmacovigilance experience required. + Strong understanding of the current global regulatory requirements that impact PV . + Proficient in case ... perspective) for focused therapeutic product and/or disease state for global regulatory responses, audits/inspections, proactive safety communications, etc. +… more
- Sumitomo Pharma (Nashville, TN)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... evaluation reports according to established safety governance policies and keeping senior leadership informed of safety issues. **Job Duties and Responsibilities** +… more
- United Therapeutics (Research Triangle Park, NC)
- …an option. **Who You Are** Do you have a deep understanding of pharmacovigilance ( PV ) regulations globally and their operational implications for a wide ... across functions. This role is responsible for management of Global Product Safety & Pharmacovigilance business alliance...healthcare or life sciences industry + 5+ years of pharmacovigilance experience + Working legal knowledge of PV… more
- United Therapeutics (Research Triangle Park, NC)
- …and practices. They will serve as a Subject Matter Expert for pharmacovigilance ( PV ), quality practices, education/training, and audits/inspections to support ... industry, or + 5+ years of working knowledge of Global and Local PV regulation, Quality Management...years of experience in oversight or establishing training in Pharmacovigilance related areas including PV Operations, Safety… more
- Ascendis Pharma (Palo Alto, CA)
- …and develop their skills. The Head of ICSR Management Team reports to the Head, Global PV Operations within the Global Patient Safety (GPS) organization. ... Under the direction of the Head, Global PV Operations, Head of ICSR Management...working on a diverse scope of activities to ensure pharmacovigilance regulations/ guidelines are adhered to. + Responsible for… more
- Boehringer Ingelheim (Ridgefield, CT)
- …activities to BI decision making bodies and the EU QPPV. + Represent Global Pharmacovigilance in internal and external committees & bodies. + Contribute ... global Oncology Therapeutic Area of Patient Safety and Pharmacovigilance at BI, whose priority is the wellbeing of...Provide updates of the assigned drug's safety profile to senior management and recommend pharmacovigilance / risk… more
- ThermoFisher Scientific (Austin, TX)
- …regional medical leadership, mentoring and oversight to direct reports (if applicable) and global PV physician team. Serves as a consultant and spokesperson of ... maybe required). **Discover Impactful Work:** Advanced leadership responsibilities within the Pharmacovigilance ( PV ) physician team which may include direct line… more
- Otsuka America Pharmaceutical Inc. (Frankfort, KY)
- …continuous inspection readiness across all clinical trial sites, clinical and Pharmacovigilance ( PV ) operations. + **Audit Management:** Oversee the planning, ... seeking an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role...Quality Systems and Risks will be reported periodically to Senior Management through the Management Review process to ensure… more
- Takeda Pharmaceuticals (Boston, MA)
- …industry and/or academia and/or CRO including significant experience in operating in a global pharmacovigilance organization. + Minimum of 3 years of experience ... my knowledge. **Job Description** **About the role:** Join Takeda as a Senior Medical Director, Pharmacovigilance in Gastrointestinal and Inflammation (GI2). You… more
- AbbVie (North Chicago, IL)
- …field. +5 years pharmaceutical industry experience; including a minimum of 3 years in pharmacovigilance Global experience + Core knowledge of global ... is responsible for monitoring and ensuring compliance with the global regulatory reporting of ICSRs. The role includes management...driving compliance and process business excellence for all ICSR PV activities + Presents results to senior … more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Global Patient Safety (GPS) Lead role (Director of GPS) serves as the first point of contact (POC) for all safety related issues for the compound(s) [asset(s)] ... in a matrix environment within and external to GPS including senior management. The GPS Director joins Regeneron's industry leading scientific organization,… more
- Takeda Pharmaceuticals (Boston, MA)
- …knowledge. **Job Description** **Objective:** **Principal responsibilities include:** + Serves as Global Safety Lead (GSL) and the Company-wide patient safety expert ... that may impact the benefit-risk profile of assigned products to senior management. + Provide medical safety expertise, medical interpretation, review, and… more