- 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
- 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
- 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
- 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
- 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
- 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
- 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
