- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …in key R&D functions (Clinical Management, Data Management, Global Pharmacovigilance , Regulatory Affairs, Asset Management), and Shared Services (Finance, Legal, ... (Clinical Management, Regulatory Affairs, Global Quality, Data Management, Global Pharmacovigilance etc.) + Provide oversight of payment schedules and milestone… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance , CROs and other vendors to ensure high quality of laboratory data ... of medical terminology capture and reporting of safety data, pharmacovigilance , industry best practices, and relevant regulatory requirements. This position… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …working closely with other functional areas such as commercial, regulatory, pharmacovigilance , CMC, early clinical and pre-clinical development in this regard. The ... or relevant clinical issues in consultation with Global Drug Safety and Pharmacovigilance , SVP Late Clinical Development and the Disease Area Heads, as needed.… more
- Amneal Pharmaceuticals (Bridgewater, NJ)
- …users. + Support internal research and POCs on advanced topics like LLM reasoning, adverse event detection, pharmacovigilance , and digital biomarker analysis. ... You will work on designing, developing, and deploying GenAI-driven solutions, retrieval-augmented generation (RAG) systems, and scalable ML-powered applications across cloud-native environments to support drug development, regulatory, manufacturing, and… more
- Novo Nordisk (Plainsboro, NJ)
- …Patient Safety experience preferred + Strong knowledge of medical and pharmacovigilance terminology required + MedDRA coding and adverse event identification ... experience preferred + Knowledge of NNI supported disease states preferred (eg diabetes, obesity, hemophilia, growth hormone disorders) + Experience with audits/inspections preferred + Analytical thinking skills required + Proficiency in Windows, Microsoft… more
- PSKW LLC dba ConnectiveRx LLC (Whippany, NJ)
- …improve processes, procedures, and training. + Ensures team follows all pharmacovigilance processes, including timely submission of AE/PQC and completion of training ... Qualifications + Bachelor's degree in business, marketing, or related discipline required. A minimum of 3-5 years of equivalent work experience may be substituted for a degree. + Minimum three years leading a claim/customer service or related team in a… more
- J&J Family of Companies (Raritan, NJ)
- …the pharmaceutical industry (eg, Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance , etc.) is required. + An understanding of pharmaceutical drug ... development is required. + Experience in discussing and communicating scientific concepts is required. + Good understanding of worldwide regulatory guidelines and their applications for guidance for labeling is required. + Experience leading project teams in a… more
- Sanofi Group (Morristown, NJ)
- …needed on various types of studies: long-term surveillance, compliance, pharmacovigilance , and effectiveness studies + Identifies data collection opportunities ... during stakeholder interactions and reports these using approved processes. + Maintains awareness of clinical trial activity within territory and suggests clinical trials sites as requested. + Responds to unsolicited requests regarding interest in investigator… more
- Merck (Rahway, NJ)
- …data that is tracked and managed within regulatory, clinical & pharmacovigilance processes + Demonstrated ability to collaborate with senior management and ... information workers on the importance and need for master data management _I_ governance + Experience in working within relevant Industry Trade Associations/Health Authorities with the ability to influence topics/outcomes in the best interest of the Company +… more
- Sanofi Group (Morristown, NJ)
- …strategy and issue escalation with the Therapeutic Area Head (TAH) and Pharmacovigilance (PV) Head + Oversee third-party safety providers during acquisition and ... development periods to ensure Sanofi safety governance processes are integrated **Internal and external safety expert** + Provide PV and risk management expertise to internal and external customers + Safety expert for product + Maintain knowledge of product,… more
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