- Novo Nordisk Inc. (Plainsboro, NJ)
- …against health authority regulations and Novo Nordisk requirements in relation to the Pharmacovigilance ( PV ) process at NNI. This role fulfills the Quality ... Interfaces with multiple NNA/S Quality departments and Quality departments in global affiliate offices. Drives and maintains a positive rapport and working… more
- CSL Behring (King Of Prussia, PA)
- …- **Safety and Pharmacovigilance Intelligence** Monitor, track and analyze global PV regulations, safety reporting requirements, and risk management ... a meaningful difference worldwide. Could you be our next Senior Manager, Regulatory Science? The job is in our...a week. You will report to the Head of Global Regulatory Science and Policy. **Position Description** **Summary** The… more
- Formation Bio (New York, NY)
- …guidance, and best practices, and providing training and mentoring on global GXP/ PV /CSV regulations and guidance. Ensuring preparedness for pre-approval ... Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GPV) and Computer Systems Validation (CSV).The primary… more
- Parexel (Des Moines, IA)
- …Continuous Improvement (QCI) colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance ( PV ), Global Regulatory Affairs (GRA), IT, ... QA and acting as the link between Clinical Development, study teams, global business functions and regional study management. + Contribute to the standardization… more
- Parexel (Baton Rouge, LA)
- …as needed with the support of the designated Senior Medical Director/ Global Head of TA (as appropriate) Pharmacovigilance Support - Provide medical input ... Medical Sciences Team as we continue to grow our Global Immunology and Inflammation Therapeutic Franchise! As an Associate...will be a member of a fantastic and cohesive global team with great mentors and work with small… more
- GE HealthCare (IL)
- …processes in compliance with regulatory requirements. This role will report to Head of Global Pharmacovigilance and Drug Safety within the GEHC Global ... local health authorities + Additional responsibilities as directed by Global Head of PV &DS ** Global ...to travel within USCAN (30%) + Strong knowledge of global pharmacovigilance regulations and guidelines, especially US… more
- Kelly Services (South San Francisco, CA)
- …$260,000-$290,000 plus annual bonus and equity **Position Overview:** The Director, Pharmacovigilance is responsible for leading global drug safety activities, ... collaborates with regulatory and clinical teams, and ensures continuous improvement of PV ( pharmacovigilance ) systems and procedures to uphold patient safety and… more
- Bristol Myers Squibb (Madison, NJ)
- …and strengthen the foundation of Patient Safety. **Position Summary / Objective** The Director, PV Global Process Lead, will design, optimize, and oversee one or ... ICSR management, signal management, safety aggregate reporting, risk management, and the PV System Master File. Partnering with Global Process Owners, the… more
- Takeda Pharmaceuticals (Boston, MA)
- …the Global Quality Audit functions consider clinical research and pharmacovigilance regulated activities are considered in their risk-based audit strategy and ... **OBJECTIVES:** + Provides oversight from a clinical research and pharmacovigilance perspective of regulated post-authorization activities in the commercial business… more
- Bayer (Whippany, NJ)
- …Lead /Oncology is responsible for leading and close collaborating with product teams of Global Safety Leaders (GSLs) and other PV BRM experts, ensuring patient ... (pre-clinical to Phase 4 and post-marketing, routine and submission PV activities) and compliance with health authority pharmacovigilance...the globe through the effective and timely completion of PV assessment activities. This is a senior … more
- Amgen (Washington, DC)
- …Amgen team. Join us and transform the lives of patients while transforming your career. Global Safety Senior Manager, Rare Disease **What you will do** Let's do ... person will also provide scientific and compliance expertise to Global Patient Safety (GPS). + Search and review adverse...for Pharmacovigilance (QPPV) as detailed in the Pharmacovigilance ( PV ) System Master File and maintain… more
- Ascendis Pharma (Princeton, NJ)
- …develop their skills. The Director, Head, 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, the Director, ICSR Management...working on a diverse scope of activities to ensure pharmacovigilance regulations/ guidelines are adhered to. + Responsible for… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- Regeneron's Patient Safety Organization is looking for a Senior Director (Obesity) to join our organization! **In this role, a typical day might include:** + ... Reporting to the Global Patient Safety (GPS) Therapeutic Area (TA) Head, the Senior Director GPS Lead, serves as the first point of contact (POC) for all safety… more
- Boehringer Ingelheim (St. Joseph, MO)
- …and forward-looking Product Surveillance & Risk Management (PSRM) program within Global Pharmacovigilance (GPV). The incumbent translates evolving and complex ... abilities. + Regulatory Agency Engagement: Proven experience working with and influencing global regulatory authorities on PV topics. + Industry Awareness:… more
- Takeda Pharmaceuticals (Boston, MA)
- …company that will inspire you and empower you to shine? Join us as a Senior Manager, Global Safety Database Configuration in our Cambridge, MA office. At Takeda, ... with business needs to guide well-informed decisions. + Strategize and plan for PV systems enhancements/projects in support of global business initiatives and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …with Gilead business needs and regulatory requirements. + Stay current with evolving global PV regulations and guidance. + Support the development of GVP ... GVP audits, in the biopharma or related industry. + Proficiency in pharmacovigilance regulatory requirements ( Global ) is a must. + Expert-level experience… more
- ICON Clinical Research (Blue Bell, PA)
- …will be an individual contributor selling Pharmacovigilance ( PV ) and Global Scientific Operations (GSO) services. As a Senior Account Executive at ICON, ... Senior Account Executive - Remote, US ICON plc...services to biotech and small to mid-sized companies + Pharmacovigilance / Drug Safety background preferred + Proven experience… 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
- Takeda Pharmaceuticals (Boston, MA)
- …complex decisions. This individual interacts with and influences Medical Strategy Team (MST), Global Project Team (GPT), senior leadership in Global Medical, ... application is true to the best of my knowledge. **Job Description** The Global Medical Lead, Dermatology is responsible for driving the medical strategy and… more
- Insight Global (Conshohocken, PA)
- Job Description The Senior Manager, IT R&D Business Analyst will drive the delivery of technology solutions and digital transformation initiatives within R&D and ... R&D landscape * Build strong relationships across Clinical Operations, Regulatory, PV , Biostats & Data Science, Clinical Pharmacology, Medical Writing, and… more
