- Genmab (Plainsboro, NJ)
- …handling of safety issues and implementing risk mitigation activitiesOversee the medical safety review for documents eg Trial Protocols and ... Strong knowledge of individual adverse event case report processing, triage and medical review Working knowledge of safety databases (ARISg, ARGUS, or other… more
- Aequor (Devers, TX)
- …and work at height. This supplemental role ensures compliance with environmental, safety , medical surveillance, and sustainability laws and regulations at the ... Key ResponsibilitiesEnsures compliance with Federal, State, and Local environmental, safety , medical surveillance, and sustainability laws, regulations, codes,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to writing minor safety sections of the NDA, CSR, and IB. May review any safety submissions for medical accuracy. Qualifications: Successful candidates ... relevant medical topics, and supports PV Operations' medical review function. This position supports a...medical knowledge to aid the SMT's signal identification efforts. Safety Expert - Signal Evaluation: Assists manager in assessing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Review Plan (IDRP)Accountable for the assessment of protocol deviationsDiscusses medical eligibility questions and answers safety questions (dose ... AEs, medical history, and medications when neededAddresses medical questions directly from sites/ Institutional Review ...review tables, listings, and figures (TLF) and CSR safety narrativesMay lead the development and updates of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Review Plan- Accountable for the assessment of protocol deviations- Discusses medical eligibility questions and answers safety questions (dose modifications, ... medical history, and medications when needed- Addresses medical questions directly from sites/ Institutional Review ...review tables, listings, and figures (TLF) and CSR safety narratives- May lead the development and updates of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Review PlanAccountable for the assessment of protocol deviationsDiscusses medical eligibility questions and answers safety questions (dose modifications, ... AEs, medical history, and medications when neededAddresses medical questions directly from sites/ Institutional Review ...review tables, listings, and figures (TLF) and CSR safety narrativesMay lead the development and updates of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Safety Physician(s) and cross-functional team to develop safety strategy, key safety messages, and review and author safety sections of Common ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...cross-functional team to develop safety strategy, key safety messages, and review and author … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and is member of the Product Labelling Committee (PLC) Review Group Review /approve deliverables of the safety surveillance team Safety surveillance of ... functions Conduct product training within therapeutic area of responsibility Review /approve deliverables of the safety surveillance team Chairmanship/membership… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory and or medical strategy and procedures are aligned with the safety strategy as well as with company objectives Liase with Patient Support Solutionsto ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk... safety updates to management on matters concerning safety promotional review , safety labelling… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for marketed products and is member of the Product Labelling Committee (PLC) Review Group Safety surveillance of Novo Nordisk products during pre-approval and ... a difference? The Position This leadership role is accountable for developing the safety strategy, major safety deliverables for assigned programs within the US… more
