- Sumitomo Pharma (Hartford, CT)
- …English. **Education and Experience** + **Medical Degree (MD) with 3-5 years of drug safety experience in a pharmaceutical company** + Experience in oncology ... Mitigation Strategy (REMS) + Contributes to PVRM and cross-functional drug development teams and manages Safety Charters...+ Prepares and presents safety information (ie safety graphs, tables, and reports) to project … more
- Boehringer Ingelheim (Ridgefield, CT)
- …review of team output. + Provide updates of the assigned drug 's safety profile to senior management and recommend pharmacovigilance / risk management ... and expert team of physicians in the global Oncology Therapeutic Area of Patient Safety and Pharmacovigilance at BI, whose priority is the wellbeing of our… more
- Boehringer Ingelheim (Ridgefield, CT)
- …antibody-based biotherapeutics, viral, and gene therapies. As the primary interface between global project teams and Nonclinical Drug Safety , the incumbent ... has oversight for the design and execution of nonclinical safety programs to support the development of drug...stages to support asset progression through development; pro-actively manage safety liabilities. + Deliver updates to Project … more
- Boehringer Ingelheim (Ridgefield, CT)
- …the assigned therapeutic area from the global regulatory, scientific, pharmaceutical, pharmacovigilance , market access and commercial perspective as well as engage ... encourage cross-functional coordination and coordinate with the (senior) regulatory project manager to achieve regulatory milestones & deliverables. The incumbent… more
- Boehringer Ingelheim (Ridgefield, CT)
- …will also provide US strategic regulatory guidance to facilitate efficient and compliant drug development and product maintenance as well as act as primary company ... liaison with the US Food and Drug Administration. This role will primarily be focused in the therapeutic area of Cardio Renal Metabolic. (CRM). + Provide analysis,… more