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Senior Manager Pharmacovigilance Assurance - New York New York
Company: Disability Solutions Location: New York, New York
Posted On: 04/25/2024
If you are a Jazz employee please apply via the Internal Career siteJazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter. Brief Description:This position primarily provides support to the Clinical and Pharmacovigilance Quality Assurance (CPVQA) function for Pharmacovigilance (PV) Systems in: - Leading the preparation for, and hosting of Regulatory Authority PV System inspections at Jazz's primary U.S. site, and external audits performed of Jazz.
- Ensuring compliance with global, local and regional PV regulations and Jazz's policies/proceduresInspection readiness is focused in GVP, but is not limited to GVP and may include supportfor Good Clinical Practice, Good Distribution Practice, Good Manufacturing Practices, and other Marketing Authorization Holder inspections where there are PV system touchpoints.Essential Functions/Responsibilities
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