- Boehringer Ingelheim (Ridgefield, CT)
- …Director OR Senior Associate Director has responsibility for the pharmacovigilance risk management activities of marketed and/or investigational compounds on ... investigational compounds. + Plan, manage / perform and monitor all pharmacovigilance activities for assigned drug responsibilities, including: + Chair or support… more
- Taiho Oncology (Princeton, NJ)
- …as an Associate Director in PV Sciences. At the forefront of pharmacovigilance innovation, we offer a dynamic and collaborative environment where your expertise ... key internal and external stakeholders, in addition to resources on pharmacovigilance -related matters. Performance Objectives: + Lead aggregate reports (eg DSUR,… more
- Takeda Pharmaceuticals (Boston, MA)
- …**OBJECTIVES:** + Provides oversight from a clinical research and pharmacovigilance perspective of regulated post-authorization activities in the commercial business ... affiliate and enables them to deliver their clinical research and pharmacovigilance -related regulated activities with high compliance and agility. + Establish and… 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 implementation of ... necessary processes for the management of routine compliance activities within the pharmacovigilance organization. This is a global role. The job holder will also… more
- Taiho Oncology (Pleasanton, CA)
- …Senior Manager, Global Labeling and PV Operations. At the forefront of pharmacovigilance innovation, we offer a dynamic and collaborative environment where your ... to inspection readiness and supports Health Authority inspections of Taiho's pharmacovigilance function. + Participates in internal PV meetings (Process improvement… more
- Bayer (St. Louis, MO)
- …routine and submission PV activities) and compliance with health authority pharmacovigilance (PV) regulations around the globe through the effective and timely ... clinical scientist position with deep expertise in key topics in pharmacovigilance (eg drug-induced liver injury (DILI), reproductive toxicity, quantitative signal… more
- Sanofi Group (Cambridge, MA)
- …that could turn the impossible into possible for millions. The Patient Safety & Pharmacovigilance (PSPV) aspiration is to be a cutting-age safety group, to enable us ... our patients and consumers. The Quality Documents Expert is part of the Pharmacovigilance Quality (PVQ) department in PSPV function working in an international and… more
- Astrix Technology (Monmouth County, NJ)
- …across various industries. We're seeking talented Medical Writers with experience in pharmacovigilance to join us! Our partners range from emerging biotech firms to ... on-site throughout the country! **Responsibilities:** + Prepare and review pharmacovigilance documents including: + Periodic Safety Update Reports (PSURs/PBRERs) +… more
- CSL Behring (King Of Prussia, PA)
- …Opportunity:** Reporting to the Head of Risk Management, Aggregate Reports & Pharmacovigilance , as the **Senior Manager, ICSR Quality** , you will have Individual ... the operational management and activities performed by the Global Case Management Pharmacovigilance vendor(s) for CSL Behring, CSL Seqirus, CSL Vifor and CSL Plasma… more
- Lilly (Indianapolis, IN)
- …Understand the roles and responsibility of the European Union Qualified Person for Pharmacovigilance (QPPV). + Ensure support is provided to enable the QPPV to ... that inform Medical Review work. + Present strong understanding of pharmacovigilance and clinical research principles, regulations, and be able to interpret… more