- 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
- 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
- Gilead Sciences, Inc. (Foster City, CA)
- …Heads of GCP and eSystems Audits, as well as with various business areas ( Global Patient Safety, QPPV, and PV Programs), lead strategic process improvement ... reviews. + Be actively involved in regulatory inspections/review of responses impacting Global Patient Safety and Pharmacovigilance programs, as appropriate. +… more
- Gilead Sciences, Inc. (Foster City, CA)
- …in Patient Safety cross-functional teams. + Communicates to highest levels of senior management key pharmacovigilance findings. + Oversees or performs medical ... of the drug development process, Good Clinical Practices (GCP) and Good Pharmacovigilance (GVP), including worldwide PV regulations and their application to… more
- Bristol Myers Squibb (Madison, NJ)
- …for ensuring the safety of our medicines. This includes all pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety ... and execution of safety post-marketing commitments and ensuring compliance with global regulatory requirements. **Position Summary / Objective** The Head of Medical… more
- ThermoFisher Scientific (Waltham, MA)
- …at Thermo Fisher Scientific is comprised of three key focus areas: query work, pharmacovigilance ( PV ) work and registry coordination. * With query work, we ... meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission...abstracts, posters, podium presentations, manuscripts, etc.). * For our pharmacovigilance ( PV ) work we design studies, analyze… more
- Takeda Pharmaceuticals (Boston, MA)
- …of my knowledge. **Job Description** **Principal responsibilities include:** + Serves as Global Safety Lead (GSL) and the Company-wide patient safety expert for ... that may impact the benefit-risk profile of assigned products to senior management. + Provide medical safety expertise, medical interpretation, review, and… 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
- Bristol Myers Squibb (New Brunswick, NJ)
- …including for- cause and directed activities. + Provide input in the global audit plans based on identified signals/trends/risks/gaps . + Partner with R ... responsible for the following:** + Defines and oversees the global quality strategy for early R&D Development up to...and manage external Quality Systems + Execute GCP and Pharmacovigilance audits and support GCP and Pharmacovigilance … more