- Orchard Therapeutics (Boston, MA)
- …subsidiary of Kyowa Kirin, a Japan-based Global Specialty Pharmaceutical Company. The Head of Pharmacovigilance will be responsible for leading ... the market. + Ensures the implementation and governance of a compliant Pharmacovigilance system consistent with industry best practices that: + Enabling real-time… more
- Sanofi Group (Cambridge, MA)
- …Area (TA) objectives, safety strategy and issue escalation with the Therapeutic Area Head (TAH) and Pharmacovigilance (PV) Head + Oversee third-party ... safety providers during acquisition and development periods to ensure Sanofi safety governance processes are integrated **Internal and external safety expert** + Provide PV and risk management expertise to internal and external customers + Safety expert for… more
- Astellas Pharma (Cambridge, MA)
- ** Head of Solid Tumor Clinical Development** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are ... role in the Oncology Development Organization. **Essential Job Responsibilities:** + The Medical Head Solid Tumor Development reports to the head of Oncology… more
- Sanofi Group (Framingham, MA)
- …knowledge in one or two domains (eg, Operational experience in Clinical, Pharmacovigilance , Manufacturing, Site Quality Head for a Manufacturing Site, etc.). ... May lead cross-functional teams for initiatives or projects. Serves as Deputy of Head of GMP/GDP Audit, Inspection - Pipeline, Launch Team. + **Latitude of action:**… more
- Takeda Pharmaceuticals (Boston, MA)
- …**About the role:** Join Takeda as a Senior Medical Director, Pharmacovigilance in Gastrointestinal and Inflammation (GI2). You will oversee medical safety ... and Governance. As part of the Patient Safety and Pharmacovigilance (PSPV) team, you will report to the Vice...you will report to the Vice President, Therapeutic Area Head of Gastrointestinal and Inflammation PSPV. You may manage/oversee… more
- Rhythm Pharmaceuticals (Boston, MA)
- …documents spanning across the development lifecycle. This role reports to the Head of Medical Writing yet works autonomously to lead work with cross-functional ... + Ensure accuracy and consistency across clinical, medical, regulatory and pharmacovigilance documents, providing expert review of study and program-level documents… more
- Takeda Pharmaceuticals (Boston, MA)
- …Description** **Objective / Purpose:** + Advance the objectives and vision of the Head of Regulatory + Ensure project management support and facilitation of the ... + Serve as a strategic thought partner to the Head of Regulatory and Head of Regulatory...in at least one of the following: clinical development, pharmacovigilance , regulatory affairs or clinical supplies + Experience in… more
- Takeda Pharmaceuticals (Boston, MA)
- …worldwide. + Assists the Global Medical Safety Oncology Therapeutic Area Head in assessing the implications of emerging regulatory intelligence and developing ... Minimum of 8 years experience in the pharmaceutical industry within Drug Safety/ Pharmacovigilance , with both investigational and marketed products. + Minimum 3 years… more
- Takeda Pharmaceuticals (Boston, MA)
- …Supplier Relationship Management (FSP) based in Cambridge, MA reporting to the Head Partnership Health and Supplier Management. At Takeda, we are transforming the ... project management, clinical monitoring, data management process, regulatory affairs, pharmacovigilance , etc.) to enable meaningful dialogue within Takeda and with… more
- Takeda Pharmaceuticals (Boston, MA)
- …within Therapeutic Area. **ACCOUNTABILITIES:** + Accountable to Oncology Clinical Science Head to provide strategic clinical input on assigned clinical studies. + ... compounds. + Reviews and assesses overall safety information in conjunction with Pharmacovigilance and Medical Monitor of record for assigned compounds. + Oversees… more