- Eurofins (Kalamazoo, MI)
- …innovative committees surrounding sustainability, equality, development, and much more! + The Pharmacovigilance Signal Management Sr. Associate will serve as ... tracking) + Build and maintain technical files within the global signal management system +...management system + Utilize technical tools with the Pharmacovigilance suite of software solutions + Provide innovative ideas… more
- Takeda Pharmaceuticals (Boston, MA)
- …with PSPV and cross-functional colleagues in the development of a global consensus on signal and risk management tools and activities. + As one of the most ... marketed products for allocated TA. + Oversees and manages signal and risk management activities undertaken by...and/or CRO including significant experience in operating in a global pharmacovigilance organization. + **Minimum of 5… more
- Takeda Pharmaceuticals (Columbus, OH)
- …industry and/or academia and/or CRO including significant experience in operating in a global pharmacovigilance organization. + Minimum of 3 years of experience ... of comprehensive safety and benefit-risk assessment strategies for products. + Oversees signal detection and risk management activities for assigned products and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …FDA, EMA, PMDA) + Established reputation as a senior leader in the global pharmacovigilance ecosystem (eg, participation in CIOMS, Navitas, Transcelerate + ... aspects of clinical studies such as protocol design, benefit-risk assessment, signal detection and management , medical monitoring of post-authorization… more
- Bayer (Boston, MA)
- …topics to the Therapeutic Area Group Head as well as senior level management committees (eg Therapeutic Area Development Committee, Global Safety Committee), ... of all phases of oncology clinical development, evidence-based medicine, clinical pharmacovigilance topics, quantitative and qualitative signal detection and the… more
- Lundbeck (Deerfield, IL)
- …Excellent working knowledge of local and global regulations/guidelines in pharmacovigilance and risk management , REMS programs. + Detailed understanding and ... and analysis of safety data/information for inclusion into aggregate reports ** Signal Management , including literature surveillance** + Responsible for safety… more
- BeiGene (Emeryville, CA)
- …Argus) for retrieval of safety information + Advanced knowledge of MedDRA and signal management system + Advanced application capability with Excel, PowerPoint, ... Qualifications:** + Pharmaceutical product development experience + Experienced in global regulatory requirements for pharmacovigilance **Travel:** Less than… more
- Novo Nordisk (Plainsboro, NJ)
- …Patient Safety Assessment activities through product development, product maintenance and lifecycle management + Ensure Signal Management processes and ... and international regulations and applicable ICH/GCP guideline + Ensure that signal detection, evaluation and management processes meet highest standards… more
- BeiGene (San Mateo, CA)
- …team members + Lead signal assessment documentation following BeiGene signal management and safety governance framework **Clinical Trial Support** + ... Argus) for retrieval of safety information + Advanced knowledge of MedDRA and signal management system + Advanced application capability with Excel, PowerPoint,… more
- Sanofi Group (Bridgewater, NJ)
- …safety input into development plans + Support due diligence activities and pharmacovigilance agreements + Responsible for signal detection and analysis + ... **About the Job** We are an innovative global healthcare company with one purpose: to chase...& External Safety Expert + Provide PV and risk management expertise to internal and external customers + Safety… more
- Sanofi Group (Cambridge, MA)
- …safety input into development plans + Support due diligence activities and pharmacovigilance agreements + Responsible for signal detection and analysis + ... **About the Job** We are an innovative global healthcare company with one purpose: to chase...& External Safety Expert: + Provide PV and risk management expertise to internal and external customers + Safety… more
- Amgen (Washington, DC)
- …be assigned as delegate for the Therapeutic Area Head (TAH) and have management of Global Safety Physicians. **Responsibilities:** + Validate safety signals and ... becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together - researching, manufacturing, and delivering… more
- Sanofi Group (Cambridge, MA)
- …safety input into development plans + Support due diligence activities and pharmacovigilance agreements ** Signal Detection & Assessment** + Responsible for ... **About the Job** We are an innovative global healthcare company with one purpose: to chase...& External Safety Expert** + Provide PV and risk management expertise to internal and external customers + Safety… more
- Taiho Oncology (Princeton, NJ)
- …substantial experience in managing adverse event and SAE processing, medical surveillance and risk management , signal detection, on a global basis within the ... and marketed products. Typically assigned work of a more complex nature and/or global products that are marketed with risk management programs. Performance… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …to health authority or other queries + Prepare and deliver presentations at Signal Management Team (SMT) meetings; participate in clinical study team meetings ... The Senior Manager of Global Patient Safety (GPS) will play a key...this role, a typical day might include:** + Complete signal detection activities in line with approved safety surveillance… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …queries and queries from other departments + Prepare and deliver presentations at Signal Management Team (SMT) meetings + Participate in clinical study team ... **SUMMARY:** We are seeking a Senior Manager of Global Patient Safety who will play a key...a typical day might include the following: + Perform signal evaluation for identified signals and author the safety… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …activities for assigned compounds and products in support of safety surveillance, signal management , communication of the safety profile as appropriate for ... The Global Patient Safety (GPS) Lead role (Director of...matrix environment within and external to GPS including senior management . The GPS Director joins Regeneron's industry leading scientific… more
- BeiGene (Emeryville, CA)
- …programs (often multi-indication) and creates and maintains a single interpretation of global safety data for developmental and marketed products. With the support ... including both BeiGene and competitor products + Identifies and actively leads management of safety concerns for developmental and approved BeiGene products +… more
- AbbVie (North Chicago, IL)
- …as the PST Lead under the direction of the Therapeutic Area (TA) Lead and Global TA Head in ensuring safety in one or more products to through surveillance, ... detection, validation and assessment. Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Responsibilities + Understanding… more
- AbbVie (North Chicago, IL)
- …or product indications under the direction of the Therapeutic Area (TA) Lead and Global TA. Ensuring safety of one or more products through the product lifecycle (eg ... surveillance, signal detection,... detection, validation and assessment). Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Responsibilities: + Understanding… more