- GE HealthCare (NJ)
- …The Responsible person for PV US & CAN will report to Head of Global Pharmacovigilance and Drug Safety within the GEHC Global Medical Services ... local health authorities + Additional responsibilities as directed by Global Head of PV &DS ** Global ...to travel within USCAN (30%) + Strong knowledge of global pharmacovigilance regulations and guidelines, especially US… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and external databases. ** Pharmacovigilance Operations & Compliance** + Oversee global PV systems and processes, including case processing, signal detection, ... This executive will set the strategic direction and oversee global safety and pharmacovigilance activities for Kite's...& Development** + Build, lead, and mentor a high-performing global safety and PV team, fostering a… more
- Sumitomo Pharma (Helena, MT)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... evaluation reports according to established safety governance policies and keeping senior leadership informed of safety issues. **Job Duties and Responsibilities** +… more
- Takeda Pharmaceuticals (Boston, MA)
- …the Global Quality Audit functions consider clinical research and pharmacovigilance regulated activities are considered in their risk-based audit strategy and ... **OBJECTIVES:** + Provides oversight from a clinical research and pharmacovigilance perspective of regulated post-authorization activities in the commercial business… more
- Boehringer Ingelheim (Duluth, GA)
- …is accountable for shaping and executing the digital vision for the Global Pharmacovigilance (GPV) organization, aligning with Boehringer Ingelheim's broader ... and drives the digital vision and innovation roadmap for Global Pharmacovigilance in alignment with corporate strategy...Expertise: + Maintains a strong understanding of local and global PV requirements, with a focus on… more
- Ascendis Pharma (Palo Alto, CA)
- …develop their skills. The Director, Head, ICSR Management Team reports to the Head, Global PV Operations within the Global Patient Safety (GPS) organization. ... Under the direction of the Head, Global PV Operations, the Director, ICSR Management...working on a diverse scope of activities to ensure pharmacovigilance regulations/ guidelines are adhered to. + Responsible for… more
- AbbVie (North Chicago, IL)
- …. Job Description Purpose: Primarily responsible for the execution of the Pharmacovigilance ( PV ) audit program, including scheduling, planning, reporting and ... resolution of PV audits. Ensuring alignment with RDQA policies and procedures...process, affiliates and third parties) to ensure compliance to global regulatory and AbbVie requirements. Effectively communicate audit results,… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …continuous inspection readiness across all clinical trial sites, clinical and Pharmacovigilance ( PV ) operations. + **Audit Management:** Oversee the planning, ... seeking an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role...Quality Systems and Risks will be reported periodically to Senior Management through the Management Review process to ensure… more
- Takeda Pharmaceuticals (Boston, MA)
- …industry and/or academia and/or CRO including significant experience in operating in a global pharmacovigilance organization. + Minimum of 3 years of experience ... my knowledge. **Job Description** **About the role:** Join Takeda as a Senior Medical Director, Pharmacovigilance in Gastrointestinal and Inflammation (GI2). You… more
- ICON Clinical Research (Blue Bell, PA)
- …will be an individual contributor selling Pharmacovigilance ( PV ) and Global Scientific Operations (GSO) services. As a Senior Account Executive at ICON, ... Senior Account Executive - Remote, US ICON plc...services to biotech and small to mid-sized companies + Pharmacovigilance / Drug Safety background preferred + Proven experience… more
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