- Amgen (Washington, DC)
- …over 10 million patients worldwide. It's time for a career you can be proud of. ** Global Pharmacovigilance ( PV ) Senior Scientist, Obesity - US Remote** ... Let's change the world. In this vital role the Global PV Senior Scientist will...**Basic Qualifications:** Doctorate degree and 2 years of safety/ pharmacovigilance experience OR Master's degree and 4 years of… more
- AbbVie (North Chicago, IL)
- …outputs of this position. Primarily responsible for the execution of the Pharmacovigilance ( PV ) audit program, including scheduling, planning, reporting and ... global quality assurance requirements. + Contributes to the PV audit program by planning and, executing PV...+ 5 years of experience in Quality Assurance and/or Pharmacovigilance An equivalent combination of education and experience may… more
- AssistRx (Maitland, FL)
- …3+ years in a compliance, oversight, or quality-driven role. + Strong knowledge of global PV regulations, including ICH guidelines and GVP Modules. + Experience ... - Front End Operations will lead frontline operational support for pharmacovigilance ( PV ) activities, directly interfacing with Quality Assurance, Patient… 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
- 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
- Boehringer Ingelheim (Duluth, GA)
- …processed within our organization. + Provides data analytics to VeTS Leadership and Global PV Leadership to assess operational performance. + Determines team ... and projects from development through successful execution under the guidance of senior leadership. The position holder is responsible for timely data collection,… more
- Bristol Myers Squibb (Princeton, 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
- 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
- Takeda Pharmaceuticals (Columbus, OH)
- …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
- 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
- J&J Family of Companies (Horsham, PA)
- …the Pharmaceuticals Chief Medical Officer (CMO), the Qualified Person for Pharmacovigilance (QPPV) Pharma, Senior Management, Health Authorities (HA), ... responsible for product safety and benefit risk oversight and represents Global Medical Safety (GMS) as the product spokesperson regarding overall benefit/risk.… more
- Bristol Myers Squibb (Summit, 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
- Sanofi Group (Bridgewater, NJ)
- …Sanofi customers, including contribution of medical information and clinical trial data for pharmacovigilance ( PV ) and regulatory reports to the US FDA and other ... our team and mirrors the healthcare communities we engage. We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by… more
- Amgen (Washington, DC)
- …of Commercial Programs and Monitoring Quality will provide guidance to Amgen senior stakeholders including Commercial, Global Patient Safety, Regulatory Affairs ... & Execution, eviation/ CAPA Management, and Privacy Issues. + Serve as the PV representative on senior compliance/ quality oversight bodies. Eg, Safety Reporting… more