- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Expert - Overall: Develops safety knowledge working closely with CSPV management . Safety Expert - Signal Identification: Carries out routine ... position works with other CSPV staff and cross functional Safety Management Team (SMT) members, often handling...by manager. Uses medical knowledge to aid the SMT's signal identification efforts. Safety Expert - Signal… more
- Tris Pharma (Monmouth Junction, NJ)
- …and leadership responsibility Current leadership and oversight experience for global safety activities, operations and risk management strategies in pre and ... safety reports, periodic safety reports, signal detection activities and risk management planning....BSN, PA, NP, PharmD, etc.) and minimum 7 years global Drug Safety /Pharmacovigilance clinical trial and post… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …through inspection readiness preparation Responsibilities - Risk Management ( Signal identification, evaluation, mitigation): - Supports proactive safety ... signals, tracks safety signals in the global electronic signal tracking tool and performs...minimization plans. Presents assessment to the appropriate forums, including Safety Management Team (SMT) or other cross-functional… more
- Insmed Incorporated (Bridgewater, NJ)
- …to the Medical Safety Leads on decisions that have significant drug safety implications, including safety signal detection activities of monitoring, ... of the benefit-risk documents for assigned products and development compounds. Develops Safety Management Plans. Directs the compilation and interpretation of … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … leadership including but not limited to clinical studies, post-marketing surveillance, signal detection and management , important safety topics, and ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...will ensure proactive safety monitoring and risk management through the Safety Management … more
- Sanofi Group (Bridgewater, NJ)
- …all deliverables. **Main Responsibilities** ** Management ** : + Management of Global Safety Leads (GSL), Signal & Risk Management Lead, PV ... desired + Excellent knowledge of global PV and medical safety , including risk management and signal detection + Interaction with key regulatory agencies,… more
- Lilly (Indianapolis, IN)
- …of Global Patient Safety 's capabilities in the field of device safety . **Primary Responsibilities:** Device Signal Management and Risk Management ... and Device Safety Physician to facilitate appropriate signal management of device safety ...eg epidemiology, toxicology, pharmacovigilance, regulatory affairs + Experience within Global Patient Safety or demonstrated knowledge and… more
- Amgen (Washington, DC)
- …expert for the team to support the Global Safety Officer in the management of safety signal , risk management activities, and benefit risk ... safety teams are accountable for the staff management and resource allocations in Global Patient...filings + Perform Signal detection, evaluation, and management + Author Safety Assessment Reports and… more
- Amgen (Washington, DC)
- …10 million patients worldwide. It's time for a career you can be proud of. ** Global Safety Senior Manager, Hematology Oncology - US Remote** **Live** **What you ... documents and regulatory responses in collaboration with the Global Safety Officer (GSO). + Prepare and...+ 4 years of pharmacovigilance experience + Experience in signal detection, evaluation and management + Experience… more
- Lilly (Indianapolis, IN)
- …Leadership Team and Safety Review Committee as required; actively contribute to the management of Global Patient Safety at strategic level. + Provide ... Medical Advisor is to perform medical roles within the Global Patient Safety (GPS) Medical function. These... of assigned product(s) including surveillance programs and risk management planning. Ensure proactive safety surveillance: lead… more
- Boehringer Ingelheim (Athens, GA)
- …with Head of PV Operations, establish and maintain scientifically valid ongoing safety surveillance and signal detection programs for marketed veterinary ... **Description** The AD Global PV Data Analysis supports the Global...products: + Actively participate in or lead safety surveillance and signal detection programs for… more
- Bristol Myers Squibb (Princeton, NJ)
- …and teams in aspects of project management , SMT requirements, core signal detection, safety data query responses, and contributions to specified PV ... detection activities and elevate program or portfolio issues impacting key Safety Management Team (SMT) programs, priorities, resources, and milestones. Drafts… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- … Patient Safety activities for assigned compounds and products in support of safety surveillance, signal management , communication of the safety ... The Global Patient Safety (GPS) lead role...matrix environment within and external to GPS including senior management . The GPS Director joins Regeneron's industry leading scientific… more
- Amgen (Washington, DC)
- …over 10 million patients worldwide. It's time for a career you can be proud of. ** Global Safety Officer (GSO), Global Safety Medical Director, Oncology, ... deliverables for assigned products. You will also lead the Safety Analysis Team (SAT), Global Safety...for the Therapeutic Area Head (TAH). **Responsibilities:** + Validate safety signals and lead safety signal… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …for all aspects of GPS activities for assigned compounds and products in support of safety surveillance, signal management , communication of the safety ... Reporting to the Global Patient Safety (GPS) Therapeutic Area...Strategic Program Team (SPT) and the Chair of the Safety Management Team (SMT) for the compound.… more
- BeiGene (San Mateo, CA)
- …for action. + Lead signal assessment and documentation following BeiGene signal management and safety governance framework. + Demonstrated ability ... around safety scientist core responsibilities including: + Signal detection and signal management ...global regulatory requirements for pharmacovigilance. + Prior people management experience is a plus. + Prior experience with… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- … Global Safety Team (GST) Chair (Medical Director). The Manager, Drug Safety will perform signal management process activities for assigned products, ... safety interactions/responses for assigned MTPG products regarding safety and risk management , both written and...global regulatory requirements related to pharmacovigilance and drug safety . + Strong knowledge in signal detection,… more
- Taiho Oncology (Princeton, NJ)
- …with Medical Surveillance Physicians towards adhoc and routine Global Safety Management Team (GSMT) meetings. + Lead signal management activities in ... biotechnology or related environment, + Proficiency in signal detection, safety surveillance, risk mitigation and risk management . + Experience directly… more
- BeiGene (Emeryville, CA)
- …issues and strategy + Execute signal assessment strategy and prepare presentations for Safety Management Team and Company Safety Committee + Prepare and ... an authoritative and professional member of relevant teams. Supports signal evaluation/ safety monitoring activities and contributes and...present safety data at safety governance meetings ( Safety Management … more
- BeiGene (San Mateo, CA)
- … assessment analysis per strategy and assist with the preparation of presentations for Safety Management Team and Company Safety Committee + Lead the ... an authoritative and professional member of relevant teams. Supports signal evaluation/ safety monitoring activities and contributes and...preparation and presentation of safety data at safety governance meetings ( Safety Management … more
