- Merck (Rahway, NJ)
- **Job Description** **The Senior Specialist, Global Pharmacovigilance will be responsible for some or all of the following core activities:** + Case ... or external stakeholders (eg, Competent Authorities) for products for which the Senior Specialist is responsible + PV Statement preparation in compliance… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Champion a culture of safety, scientific integrity, and innovation across the organization. ** Pharmacovigilance Operations** * Oversee global PV systems and ... **Key** **Responsibilities** **Strategic Leadership** * Define and execute a comprehensive global safety and pharmacovigilance strategy aligned with corporate… more
- Sumitomo Pharma (Augusta, ME)
- 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
- United Therapeutics (Columbus, OH)
- …and practices. They will serve as a Subject Matter Expert for pharmacovigilance ( PV ), quality practices, education/training, and audits/inspections to support ... industry, or + 5+ years of working knowledge of Global and Local PV regulation, Quality Management...years of experience in oversight or establishing training in Pharmacovigilance related areas including PV Operations, Safety… more
- Lilly (Indianapolis, IN)
- …, or drug development. + Demonstrated effective people leadership. + Knowledge of global and local PV regulations and legislation, pre- and post-marketing. + ... better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees...people around the world. **Purpose:** The purpose of the Senior Director - Benefit-Risk Management Group Leader is to… 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
- 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
- Gilead Sciences, Inc. (Foster City, CA)
- …with Gilead business needs and regulatory requirements. + Stay current with evolving global PV regulations and guidance. + Support the development of GVP ... GVP audits, in the biopharma or related industry. + Proficiency in pharmacovigilance regulatory requirements ( Global ) is a must. + Expert-level experience… 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
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Global Patient Safety (GPS) Lead role (Director of GPS) serves as the first point of contact (POC) for all safety related issues for the compound(s) [asset(s)] ... in a matrix environment within and external to GPS including senior management. The GPS Director joins Regeneron's industry leading scientific organization,… more
- AbbVie (North Chicago, IL)
- …and communication, underpinned by emotional intelligence + Thorough understanding of global PV regulations, risk management, labelling and the interconnectedness ... professionals responsible for signal detection, surveillance, medical safety review, and Pharmacovigilance ( PV ) leads across various regions, fostering a culture… more
- Orchard Therapeutics (Boston, MA)
- …to: Chief Medical Officer Orchard Therapeutics, a Kyowa Kirin company, is a global gene therapy leader focused on transforming the life of patients with rare ... gene therapies based on gene-modified hematopoietic stem cell (HSC). Orchard has its global headquarters in London and US headquarters in Boston. Reporting to the… more
- AbbVie (North Chicago, IL)
- …(PST) within the Pharmacovigilance and Patient Safety (PPS) organization's Global PV Strategy Management Office. The PPS organization works collaboratively ... of residence. There is the potential for this role to be a Senior Manager level role, depending on experience. Qualifications Required education: + Bachelor's degree… more
- Takeda Pharmaceuticals (Boston, MA)
- …knowledge. **Job Description** **Objective:** **Principal responsibilities include:** + Serves as Global Safety Lead (GSL) and the Company-wide patient safety expert ... that may impact the benefit-risk profile of assigned products to senior management. + Provide medical safety expertise, medical interpretation, review, and… more
- Sanofi Group (Morristown, NJ)
- …Sanofi customers, including contribution of medical information and clinical trial data for pharmacovigilance ( PV ) and regulatory reports to the US FDA and other ... data generation, scientific exchange, and stakeholder engagement. We are an innovative global healthcare company that helps the world stay ahead of infectious… more