- Insmed Incorporated (NJ)
- …etc. Global Pharmacovigilance experience, including robust knowledge of global PV regulations and applicable ICH guidelines.Experience in preparing ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...Are you?About the Role:We are seeking a highly experienced Senior Director, DSPV Medical Safety to help us expand… 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
- Capgemini (Chicago, IL)
- … tools and frameworks (eg, maturity models, checklists, methodologies). + Stay updated on global PV regulations (FDA, EMA GVP, ICH E2) and new trends like ... and identify new revenue sources. **YOUR ROLE** **Scope & Responsibilities** As a Senior Consultant, you will act as a ** pharmacovigilance and drug safety… more
- Taiho Oncology (Princeton, NJ)
- …with Taiho Oncology as a Senior Manager, Global Labeling and PV Operations. At the forefront of pharmacovigilance innovation, we offer a dynamic and ... in our rapidly evolving organization. Position Summary: The Senior Manager, Global Labeling Innovation & PV Operations, leads the creation, maintenance, and… more
- Taiho Oncology (Princeton, NJ)
- …on a transformative journey with Taiho Oncology as a Senior Manager in PV Sciences. At the forefront of pharmacovigilance innovation, we offer a dynamic and ... on your experience in our rapidly evolving organization. Position Summary: The Senior Manager, PV Sciences role will support medical surveillance activities… 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
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- **Job Description** The Senior Manager, Global Pharmacovigilance (GPV) Compliance & Business Management (CBM), will support in the development and ... for the management of routine compliance activities within the pharmacovigilance organization. This is a global role....will also work collaboratively with other GPV groups, Affiliate PV Coordination Group (APVC), Global Quality Operations… more
- Bayer (St. Louis, MO)
- …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
- Parexel (Olympia, WA)
- Join our dynamic Patient Safety team as a ** Senior Physician** where you'll leverage your medical expertise to ensure the safety of patients in clinical trials and ... comprehensive medical reviews, provide expert safety monitoring, and deliver pharmacovigilance guidance across assigned projects. You'll also mentor junior team… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Director OR Senior Associate Director has responsibility for the pharmacovigilance risk management activities of marketed and/or investigational compounds on a ... Provide updates of the assigned drug's safety profile to senior management and recommend pharmacovigilance / risk... global regulatory environment). + In addition to global responsibilities, may represent PV at US-specific… 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
- CSL Behring (King Of Prussia, PA)
- …+ Minimum of 8 years of Clinical Trial and Post-marketing Pharmacovigilance ( PV ) experience. + Global pharmacovigilance database knowledge is required ... to the Head of Risk Management, Aggregate Reports & Pharmacovigilance , as the ** Senior Manager, ICSR Quality**...of the operational management and activities performed by the Global Case Management Pharmacovigilance vendor(s) for CSL… 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
- Sanofi Group (Morristown, NJ)
- …Sanofi customers, including contribution of medical information and clinical trial data for pharmacovigilance ( PV ) and regulatory reports to the US FDA and other ... innovation, and AI-driven breakthroughs. In Vaccines, you'll help advance prevention on a global scale - and shape the future of immunization. The North American… more
- Parexel (Columbia, SC)
- …as needed with the support of the designated Senior Medical Director/ Global Head of TA (as appropriate) Pharmacovigilance Support * Provide medical input ... an Associate/Medical Director to support the growth of 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
