- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Specialist, Global Pharmacovigilance will be responsible for some or all of the following core activities:Case review/approval for ... with a hybrid work schedule.DESIRED QUALIFICATIONS:Knowledge of regulations governing pharmacovigilance for veterinary medicinesExperience with PV databasesStrong… more
- Insmed Incorporated (San Diego, CA)
- …written). Global Pharmacovigilance experience, including robust knowledge of global PV regulations and applicable ICH guidelines is strongly desired. ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Senior Director, DSPV Gene Therapy Safety Lead will be… more
- Amgen (Washington, DC)
- …team. Join us and transform the lives of patients while transforming your career. ** Global Pharmacovigilance ( PV ) Senior Scientist** **What you will ... strategy and major safety deliverables for each Amgen product. Amgen is seeking a Global Pharmacovigilance ( PV ) Senior Scientist to work out of their… more
- Merck (Rahway, NJ)
- **Job Description** **The Senior Specialist, Global Pharmacovigilance will be responsible for some or all of the following core activities:** + Case ... or external stakeholders (eg, Competent Authorities) for products for which the Senior Specialist is responsible + PV Statement preparation in compliance… more
- Takeda Pharmaceuticals (Boston, MA)
- …PhD, or PharmD + Minimum 15 years of pharmaceutical experience + Advanced knowledge of PV and global PV regulations + Experience working in a ... + Supports and advocates the vision and mission of Global Patient Safety & Pharmacovigilance (PSPV) as...and Benefit Risk Center of Excellence:** + Oversees the PV Risk Management Center of Excellence, ensuring its continuous… more
- Taiho Oncology (Princeton, NJ)
- …a dynamic, collaborative, and global cross-functional environment. Position Summary: The Senior Director of Quality Assurance, Pharmacovigilance ( PV ) is ... creative and pragmatic solutions to issues and risks. + In-depth knowledge of global pharmacovigilance regulations and guidelines, including FDA, EMA, and ICH. +… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …compliance.** **This role will work** **collaboratively with other stakeholders from Global Pharmacovigilance ** **(GVP) groups, Affiliate PV ** **Coordination ... Manager,** **GPV Compliance & Business Management will support the** **leads of Global PV ** **Audit & Inspection readiness** **(AIR)** **activities** **and** **… 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
- 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
- Boehringer Ingelheim (Ridgefield, CT)
- …management activities to BI decision making bodies and the EU QPPV + Represent Global Pharmacovigilance in internal and external committees & bodies. This may ... the global Cardio-metabolism/Respiratory Therapeutic Area of Patient Safety and Pharmacovigilance at BI, whose priority is the wellbeing of our patients… more
