- Takeda Pharmaceuticals (Boston, MA)
- …+ Minimum of 5 years prior experience in pharmaceutical industry in a drug safety / pharmacovigilance global setting + Experience in developing procedural ... Ensures adequate training support to all functional areas within Patient Safety & Pharmacovigilance (PSPV) in a Pharmacovigilance (PV) regulated environment.… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Minimum of 8 years experience in the pharmaceutical industry within Drug Safety / Pharmacovigilance , with both investigational and marketed products. ... expert for assigned oncology pharmaceutical / biological / drug -device combined products, accountable for the safety .../ drug -device combined products, accountable for the safety strategy and major safety deliverables for… more
- Takeda Pharmaceuticals (Boston, MA)
- …preferred. + At least 5 years of experience in pharmaceutical industry within Drug Safety / Pharmacovigilance , with both investigational and marketed products. ... Company-wide patient safety expert for assigned pharmaceutical / biological / drug -device combined products, accountable for the safety strategy and major … more
- Takeda Pharmaceuticals (Boston, MA)
- … Pharmacovigilance Scientist with the following duties: Facilitate ongoing safety surveillance for assigned products, assisting with data collection and ... Signal Evaluation Reports, and Health Authority responses; Contribute to safety -related deliverables associated with new drug applications, benefit-risk… more
- Takeda Pharmaceuticals (Boston, MA)
- …Company-wide patient safety expert for assigned pharmaceutical / biological / drug -device combined products, accountable for the safety strategy and major ... and develop risk management plans including risk minimization measures to address specific safety concerns related to the drug in development or a product… more
- Sumitomo Pharma (Boston, MA)
- …English. **Education and Experience** + **Medical Degree (MD) with 3-5 years of drug safety experience in a pharmaceutical company** + Experience in oncology ... Evaluation and Mitigation Strategy (REMS) + Contributes to PVRM and cross-functional drug development teams and manages Safety Charters + Handles Health… more
- Takeda Pharmaceuticals (Boston, MA)
- …and AI/Machine Learning to support the department's data needs; Solve business problems in drug safety which provide an increased understanding of such tools and ... (PV) reporting & analytic solutions for Takeda Patient Safety & Pharmacovigilance (PSPV); Identify and develop...related experience. Prior experience must include: Utilize knowledge of drug safety systems, including the underlying data… more
- Takeda Pharmaceuticals (Boston, MA)
- …of experience in people management. + Demonstrated knowledge of regulatory agency requirements regarding drug safety and an understanding of general drug ... company-wide Committees and Governance. As part of the Patient Safety and Pharmacovigilance (PSPV) team, you will...analyses of safety information, in support of safety update regulatory submissions, investigational and new drug… more
- United Therapeutics (Boston, MA)
- …plays a key role in management and oversight of end-to-end case safety management activities spanning across our global commercial product portfolio. This position ... to ensure compliance with global regulations and guidelines with regards to safety data collection, management and reporting for postmarketing ICSRs for efficiency,… more
- Takeda Pharmaceuticals (Boston, MA)
- …Affairs, Regulatory Affairs, Biostats) to ensure alignment of global position for pharmacovigilance risk management processes to maximize patient safety + ... strategic expertise to cross-functional product team members in developing pharmacovigilance risk strategies including benchmarking and scenario planning. + Support… more