- 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
- 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
- Sumitomo Pharma (Trenton, NJ)
- …a dynamic, highly motivated, and experienced individual for the position of Pharmacovigilance Scientist to perform PV activities for assigned programs(s). Ability to ... ongoing clinical trials. + Serve as a subject matter expert in Pharmacovigilance , including operations and medical, within the assigned program. + Support… more
- Ascendis Pharma (Princeton, NJ)
- …+ Raise or increase awareness, knowledge and understanding of pharmacovigilance requirements by conducting education/training sessions with functional partners / ... Safety Database. + Reviews and provides input to Business Partner or Pharmacovigilance Agreements and Safety Data Exchange Agreements (SDEA) to ensure appropriate… more
- System One (East Windsor, NJ)
- …be responsible for establishing the internal QA review system to supervise the Pharmacovigilance Group (PVG) function, which is handled by a third-party vendor. + ... Procedures (MAPPs), internal guidelines, and review checklists to supervise the Pharmacovigilance Group (PVG) function of company products. + Coordinate with… more