- United Therapeutics (Trenton, NJ)
- …plays a key role in management and oversight of end-to-end case safety management activities spanning across our global commercial product portfolio. This position ... to ensure compliance with global regulations and guidelines with regards to safety data collection, management and reporting for postmarketing ICSRs for efficiency,… 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 ... **Job Title:** Global Safety Officer, Oncology **Location** : Cambridge, MA, Morristown,...development periods to ensure Sanofi safety governance processes are integrated **Internal and external … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …**Summary** The Executive Director, Head of Center of Excellence (CoE), Global Medical Safety will oversee a team of safety physicians and scientists across ... various regions, offering guidance and support to each product safety team in critical areas such as individual case...of the CoE group comply with Good Clinical and Pharmacovigilance Practices, as well as all relevant internal and… more
- Novo Nordisk (Plainsboro, NJ)
- …The Position Responsible for the receipt, documentation and triage of safety information, including adverse events and technical complaints for Novo Nordisk ... is met with all internal and external (eg FDA) drug and device safety reporting regulations. Relationships Reports to Patient Safety Management. Daily internal… more
- Sanofi Group (Morristown, NJ)
- …Development, Regulatory, etc. to facilitate diligence reviews, medical and safety evaluation, product positioning, lifecycle evidence planning, and compliance needs. ... needed on various types of studies: long-term surveillance, compliance, pharmacovigilance , and effectiveness studies + Identifies data collection opportunities… more
- AbbVie (Florham Park, NJ)
- …(medical education, data, guidelines and value proposition); safeguarding patient safety (risk minimization activities / safety surveillance activities). ... role in a TA preferred. + Must have an understanding of the Pharmacovigilance practices for Clinical Development programs. + Must have an in-depth understanding of… more
- Sanofi Group (Morristown, NJ)
- …development scientists, in the project in collaboration with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver ... benefit-risk profile during development and LCM, in strong collaboration with pharmacovigilance and clinical operations team + Implements strategies to identify,… more