- Sanofi Group (Morristown, NJ)
- …drive breakthroughs that could turn the impossible into possible for millions. The Patient Safety & Pharmacovigilance (PSPV) aspiration is to be a cutting-age ... 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
- Parexel (Trenton, NJ)
- …this pivotal role, you'll perform comprehensive medical reviews, provide expert safety monitoring, and deliver pharmacovigilance guidance across assigned ... all Key Performance Indicators (KPIs) for the process + Function as pharmacovigilance representative/ safety scientist + Attend/support Bid defense meetings +… more
- Sanofi Group (Morristown, NJ)
- …including Clinical Trial Managers and Data Managers), Regulatory Affairs, Patients Safety & Pharmacovigilance , Therapeutic Area Research & Development Groups. ... including Clinical Trial Managers and Data Managers), Regulatory Affairs, Patients Safety & Pharmacovigilance , Therapeutic Area Research & Development Groups.… more
- Astrix Technology (Red Bank, NJ)
- …and on-site throughout the country! **Responsibilities:** + Prepare and review pharmacovigilance documents including: + Periodic Safety Update Reports ... or regulatory affairs. + Strong knowledge of drug safety regulations and pharmacovigilance systems. + Proficiency with safety databases, literature… more
- Parexel (Trenton, NJ)
- …**medical monitoring** and clinical trial design/execution + Knowledge of drug safety and pharmacovigilance processes **Essential Skills** + **Exceptional ... **Medical Monitor** for gastroenterology studies, ensuring scientific integrity and patient safety + Provide expert medical oversight throughout the clinical trial… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …agency (FDA/Health Canada) within timelines to achieve 100% compliance with US pharmacovigilance regulatory norm + Anchor drug safety regulatory inspection in ... **Job Description** We are seeking an exceptional leader to Head Pharmacovigilance and Medical Affairs including medical information function for Dr. Reddy's… more
- Sumitomo Pharma (Trenton, NJ)
- …clinical sections for INDs, NDAs, and other related documents. + Partner with Drug Safety & Pharmacovigilance to assess the safety profile of compounds. ... monitoring overall study integrity, and review, interpretation, and communication of safety and efficacy data. + Present at scientific, medical, and regulatory… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …site selection and performance. + Support other areas of the organization including Safety & Pharmacovigilance for investigation of safety -related issues, ... Sales Training medical education on an ongoing basis including new hire and POAs, and the Field Medical Center of Excellence for mentoring and sharing of best practices. **Qualifications** + Advanced degree in Pharmacy, Medicine, Biological Sciences, Health… more
- Cytel (Trenton, NJ)
- …skill set, the role may also include strategic consulting on clinical, safety / pharmacovigilance , regulatory, and market access pathways to accelerate patient ... access to new health technologies. **Client Leadership & Strategic Advisory** + Serve as an externally recognized thought leader in clinical development, regulatory strategy, market access strategy, and quantitative clinical methods. + Provide strategic… more
- Sanofi Group (Morristown, NJ)
- …all function stakeholders (eg clinical operations, project management, Patient Safety and Pharmacovigilance , regulatory, Finance, Scientific External Engagement, ... under the leadership of the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver… more