- Takeda Pharmaceuticals (Boston, MA)
- …and present complex safety data to a high standard during internal and global cross-functional collaborations for patient safety (2 years). + Excellent ... efficient and timelyattainment of compliant and patient -focused safety data. + Represent the pharmacovigilance department...respond to safety issues. + Participate in Global Safety Teams, coordinating all aspects of… more
- Sumitomo Pharma (Boston, MA)
- …team members to manage the benefit-risk profile of assigned products, ensuring patient safety . + Review literature search strategies and literature monitoring ... in cross-functional Steering Committee meetings and at partner meetings including Joint Safety Forums (JSFs) and Pharmacovigilance Committee (PVC) meetings. +… 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
- United Therapeutics (Boston, MA)
- …finding solutions and ensuring training standards are implemented and successful. This role in Global Patient Safety (GPS) will focus on enhancing and ... industry, or + 5+ years of working knowledge of Global and Local PV regulation, Quality Management principles +...years of experience in oversight or establishing training in Pharmacovigilance related areas including PV Operations, Safety … 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
- Takeda Pharmaceuticals (Cambridge, MA)
- …the capture, archiving and reporting of appropriate study level information (including patient safety information) and deliverables. + Oversee and/or facilitate ... the best of my knowledge. **Job Description** **About the role:** The GMA, Global Medical Evidence Operations Manager will manage the operational conduct of Medical… more
- Sumitomo Pharma (Boston, MA)
- …team members to manage the benefit/risk profile of assigned products and ensure patient safety . + Assist in signal detection activities including data assembly, ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...external partners **Key Core Competencies** + Strong understanding of pharmacovigilance regulations and drug safety reporting requirements… more
- Takeda Pharmaceuticals (Boston, MA)
- …tools, global submission management, labeling platforms, IDMP readiness). Pharmacovigilance Technologies ( safety databases, signal detection, case processing ... Regulatory, and Pharmacovigilance domains. + Strong understanding of global regulatory and safety compliance requirements and technologies supporting… more
- Takeda Pharmaceuticals (Boston, MA)
- …global position for pharmacovigilance risk management processes to maximize patient safety + Provide strategic expertise to cross-functional product team ... on incorporation of the patient 's perspective into benefit-risk activities (eg patient preference studies) + Collaborate with Safety Leads, Clinical Leads,… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Job Description** **Objective:** **Principal responsibilities include:** + Serves as Global Safety Lead (GSL) and the Company-wide patient safety ... and CTAs) in collaboration with cross-functional colleagues. + Provide patient safety input to the clinical development...Support GPSE in the maintenance of a highly effective global safety organization in full compliance to… more
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