- Sanofi Group (Cambridge, MA)
- …deliverables requiring EGDS expertise, including innovations in pharmacovigilance , portfolio management, patient-centric early development including diversity ... in clinical trials, digital biomarkers, and novel clinical trial designs + Drive development and scaling of advanced statistical tools and frameworks in collaboration with the DevAI initiative team to accelerate evidence generation and decision support. For… more
- System One (Plainsboro, NJ)
- …to support the Compliance Team within the Global Drug Safety and Pharmacovigilance (GDS&PV) Department. The ideal candidate will possess a methodical approach to ... task prioritization, particularly when handling multiple assignments, must demonstrate strong documentation governance, inspection readiness, and cross-functional collaboration across our global safety network. Key Responsibilities Inspection & Audit Readiness… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …overall safety information for studies and compound in conjunction with Pharmacovigilance . Oversees non-medical clinical scientists with respect to assessment of ... these issues. + Makes final decisions regarding study conduct related to scientific integrity. + **External Interactions** + Directs activities involved in interactions with regulatory authorities / agencies and clinical development activities undertaken to… more
- Lilly (Indianapolis, IN)
- …key regulatory discussions. + Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality ... standards in conducting research. **Minimum Requirements:** + Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in Oncology or Hematology (or equivalent) or have completed the comparable level of post-medical school clinical training… more
- Sanofi Group (Morristown, NJ)
- …customers, including contribution of medical information and clinical trial data for pharmacovigilance (PV) and regulatory reports to the US FDA and other health ... authorities + Collaborate with marketing teams to link sound evidence to brand strategy + Represent as country medical expert in all product label updates and product Company Core Datasheet (CCDS) updates **Data Generation (15%)** + Work with R&D and Clinical… more
- BeOne Medicines (Emeryville, CA)
- …clinical development, program leadership, biometrics, clinical operations, safety/ pharmacovigilance , regulatory, molecular diagnostics, and translational research. ... **Essential Functions of the Job:** + Facilitate generation of, author, update, and/or review key documents, including, but not limited to: + Protocol concepts, synopses, protocols, and amendments + Informed consent documents + Investigator Brochures +… more
- Boehringer Ingelheim (Ridgefield, CT)
- …area from the global regulatory, legislative, scientific, medical, pharmaceutical, pharmacovigilance , market access and commercial perspective. **Additional Duties & ... Responsibilities** + US-Focused Project Team Support: + Provide US regulatory strategic input and advice to US cross-functional teams during development, registration, and marketing approval. Includes, for example, detailed assessment of potential labeling… more
- Lilly (Indianapolis, IN)
- …of prior people management experience. + 2+ Prior experience in Pharmacovigilance area + Prior experience implementing small and large systems/technology projects ... **Other Information/Additional Preferences:** + Prior systems ownership, systems implementation. + Demonstrated application of process automation and analytics cross-functionally. + Demonstrated strategic thinking skills and driving broad change. +… more
- BeOne Medicines (Emeryville, CA)
- …clinical development, program leadership, biometrics, clinical operations, safety/ pharmacovigilance , regulatory, molecular diagnostics, and translational research. ... Essential Functions of the job: + Facilitate generation of, author, update, and/or review key documents, including, but not limited to: + Protocol concepts, synopses, protocols, and amendments + Informed consent documents + Investigator Brochures + Clinical… more
- CVS Health (Blue Bell, PA)
- …automate routine data management tasks + Analytical background in pharmacovigilance , Pharmacoeconomics, safety surveillance, and/or outcomes research using Real ... World Datasets **Education** Masters Preferred, Bachelors Degree required **Pay Range** The typical pay range for this role is: $130,295.00 - $260,590.00 This pay range represents the base hourly rate or base annual full-time salary for all positions in the… more