- Insmed Incorporated (NJ)
- …the identification of risks and appropriate risk minimization and pharmacovigilance measures in compliance with regulatory requirements. Develop/provide input to ... appropriate teams and individuals.Lead all aspects of medical safety and pharmacovigilance activities conducted in partnership with external business partners or… more
- Insmed Incorporated (NJ)
- …heads of clinical operations, toxicology, regulatory affairs, commercial, pharmacovigilance , clinical quality, and biostatistics.Provide medical leadership for key ... areas of clinical operational strategy, particularly with respect to site selection, enrollment, feasibility, etc., and serve as primary, point of escalation for all issues identified which may affect the quality and integrity of clinical studies.Perform… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …**Job Description** We are seeking an exceptional leader to Head Pharmacovigilance and Medical Affairs including medical information function for Dr. Reddy's ... agency (FDA/Health Canada) within timelines to achieve 100% compliance with US pharmacovigilance regulatory norm + Anchor drug safety regulatory inspection in US… more
- Parexel (Trenton, NJ)
- …comprehensive medical reviews, provide expert safety monitoring, and deliver pharmacovigilance guidance across assigned projects. You'll also mentor junior team ... with clients, and contribute to the continuous improvement of our pharmacovigilance processes. **Key Accountabilities:** **General** + Maintaining a good working… 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
- 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
- Bayer (Whippany, NJ)
- …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
- Ascendis Pharma (Princeton, NJ)
- …about patient safety and ready to help lead a fast-paced, global pharmacovigilance organization? Ascendis Pharma is seeking an experienced Program Safety Lead to ... Science. You will play a pivotal role as the Program Safety Lead and pharmacovigilance expert for the Ascendis' endocrinology pipeline. As a key member of the Global… more
- Sanofi Group (Morristown, NJ)
- …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
