- 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
- AbbVie (Jersey City, NJ)
- …as well as PMOS. PST lead will be interpreting regulations related to pharmacovigilance supporting all patient safety activities, and will be leading the safety ... products + Lead and set the strategy for key pharmacovigilance documents, including but not limited to, medical safety...DO, not required + 5 - 8 years of Pharmacovigilance (PST lead role equivalent) / Clinical Development experience… more
- Sanofi Group (Morristown, NJ)
- …Trial Managers and Data Managers), Regulatory Affairs, Patients Safety & Pharmacovigilance , Therapeutic Area Research & Development Groups. + External contacts: ... Trial Managers and Data Managers), Regulatory Affairs, Patients Safety & Pharmacovigilance , Therapeutic Area Research & Development Groups. + External contacts:… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …across all regions and business functions-including clinical research, pharmacovigilance , employee data, and commercial operations-complies with applicable laws, ... healthcare industry, including familiarity with clinical data, patient privacy, and pharmacovigilance requirements. + Deep understanding of global privacy and data… more
- Sanofi Group (Morristown, NJ)
- …safety input into development plans + Support due diligence activities and pharmacovigilance agreements **Impact:** + Ongoing assessment of the safety status of the ... + For MD, minimum 3 years' total experience in international pharmacovigilance , or equivalent relevant industry experience (eg clinical development) with relevant… more
- Sanofi Group (Morristown, NJ)
- …safety input into development plans + Support due diligence activities and pharmacovigilance agreements **Impact:** + Ongoing assessment of the safety status of the ... is preferred + Minimum 3 years' total experience in international pharmacovigilance , or equivalent relevant industry experience (eg clinical development) with… more
- Sanofi Group (Morristown, NJ)
- …Data Managers, Global and Regional Study Managers, Feasibility Managers, Pharmacovigilance representative, Medical Writer (eg planning and review of narratives) ... safety cases with the Clinical Trial Team (Monitoring Teams) or Pharmacovigilance . **About You** **Knowledge And Skills Required** : + Ophthalmology/retina clinical… more
- Deloitte (Morristown, NJ)
- …include: + Project Leadership: Lead the delivery of and pharmacovigilance projects, including business process transformation, technology enablement, and regulatory ... Engineering, or related field + 4+ years of experience in life sciences, pharmacovigilance , or consulting + 4+ years of experience implementing and working with… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …Clinical Scientist. and other functional areas such as GCO, biostats, regulatory, pharmacovigilance . The Director will be a key contributor to INDs, NDAs, BLAs, ... and other global regulatory filings and publications. The Director will foster relationships with opinion leaders in assigned therapeutic area. The CTP is a member of the study team and CDT. The CTP is expected to advance scientific and clinical knowledge,… more
- Organon & Co. (Jersey City, NJ)
- …in R&D functions (eg, Clinical Research, Early Development, Medical Affairs, Pharmacovigilance , Regulatory Affairs, etc.) + At least three years of experience ... in project management. + Proficient with MS Project, MS Timeline, and all Office products. + A working understanding of and application of principles, concepts, practices, and standards of pharmaceutical project management. + Worked on programs in one or more… more