- Sanofi Group (Cambridge, MA)
- … patient safety experience and clinical data. + Collaborate within Global Pharmacovigilance for optimizing signal detection, benefit risk assessment and ... and implementation of project-level strategy plan + Provide expertise on translational patient safety based on biomarkers, precision medicine, and real-world… more
- Orchard Therapeutics (Boston, MA)
- …Company. The Head of Pharmacovigilance will be responsible for leading Pharmacovigilance for Orchard, driving patient safety , regulatory compliance, and ... of commercial drug safety databases and managing software supporting global Pharmacovigilance operations + Gene therapy/ultra rare/orphan diseases background… more
- Takeda Pharmaceuticals (Boston, MA)
- …of critical documents (eg, protocols, ICFs, IBs, etc.); Assist with the presentation of patient safety risks and SMT recommendations on safety issues to ... other labelling documents; Support GPSE in the maintenance of a highly effective global safety organization in full compliance to worldwide regulations. 10%… more
- Takeda Pharmaceuticals (Boston, MA)
- …& Purpose:** + Ensures adequate training support to all functional areas within Patient Safety & Pharmacovigilance (PSPV) in a Pharmacovigilance ... Minimum of 5 years prior experience in pharmaceutical industry in a drug safety / pharmacovigilance global setting + Experience in developing procedural… more
- Takeda Pharmaceuticals (Boston, MA)
- …, Rare Disease & PDT with the following duties: Serve as Global Safety Lead (GSL) and the Company-wide patient safety expert for assigned ... INDs, NDAs, BLAs, and CTAs) in collaboration with cross-functional colleagues; provide patient safety input to the clinical development program for assigned… more
- Sumitomo Pharma (Boston, MA)
- …of drug development in the pharmaceutical industry, including clinical research and global regulatory requirements + Experience managing safety data, expedited ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases,… more
- Sanofi Group (Cambridge, MA)
- …connectivity with leadership across Medical, Patient Safety & Pharmacovigilance , Market Access, New Product Planning, Global Regulatory to align the ... and benefit assessments, modeling and simulation, etc + Knowledge of global public health systems, emerging challenges, patient driven decision-making… more
- Takeda Pharmaceuticals (Boston, MA)
- …duties: Deliver pharmacovigilance (PV) reporting & analytic solutions for Takeda Patient Safety & Pharmacovigilance (PSPV); Identify and develop methods ... understanding of such tools and techniques. Identify and document Global Pharmacovigilance reporting end-user system needs and...identify and remediate issues with the configuration of the global safety database and its associated data.… more
- Sumitomo Pharma (Boston, MA)
- …and inspection preparedness and supports PVRM during regulatory inspections and audits. + Global safety planning and coordination member to support global ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...checks. + Contributes to standard operating procedures relevant to pharmacovigilance . + Assist with other Safety department… more
- Takeda Pharmaceuticals (Boston, MA)
- …and be a core member of company-wide Committees and Governance. As part of the Patient Safety and Pharmacovigilance (PSPV) team, you will report to the ... required. You will define and implement a vision for Patient Safety , enhance medical safety ...and/or CRO including significant experience in operating in a global pharmacovigilance organization. + Minimum of 3… more