- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …leadership. + Ensure the intake and workflow procedures are aligned with pharmacovigilance agreements. + Coordinate with ICSR and Aggregate Submission teams to ... Nursing, or a related field in healthcare. + Six (6) years of experience with pharmacovigilance . + Six (6) years of experience using Argus safety database. + Six (6)… 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
- 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)
- …exchange. + Ensure **cross-functional collaboration** with Commercial, Regulatory, Pharmacovigilance , and Market Access teams; review promotional and non-promotional ... and other communication channels. + Provide medical support to **R&D, Pharmacovigilance , and Regulatory functions** , including risk management and health authority… more
- Sanofi Group (Morristown, NJ)
- …input into development plans + Support due diligence activities and pharmacovigilance agreements **Signal Detection & Assessment** + Responsible for signal detection ... is preferred + Minimum 3 years total experience in international pharmacovigilance , or equivalent relevant industry experience (eg clinical development) with… more
- Oracle (Trenton, NJ)
- …will be responsible for selling Oracle's full suite of clinical, trial management and pharmacovigilance products as well as the new AI data platform for research and ... **Clinical Research product summary;** **https://www.oracle.com/industries/life-sciences/clinical-research/products/** ** Pharmacovigilance product summary;** **https://www.oracle.com/industries/life-sciences/ pharmacovigilance… more
- Parexel (Trenton, NJ)
- …medical insights to protocol design and drug development programs + Support pharmacovigilance activities including medical review of serious adverse events + Provide ... and clinical trial design/execution + Knowledge of drug safety and pharmacovigilance processes **Essential Skills** + **Exceptional communication skills** - both… 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