• Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …well as other research areas centered around rare diseases and immune disorders. Summary The Senior Director, Head Global PV Quality (DSI/DSE) reports to the ... of direct reports (Directors, Associate Directors, Managers, contractors as applicable) across the Global PV Quality teams located in Europe and the Americas.… more
    HireLifeScience (06/01/24)
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  • Insmed Incorporated (Bridgewater, NJ)
    …lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of Pharmacovigilance QA serves as a strategic ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...partner managing quality and regulatory compliance related to Good Pharmacovigilance Practices (GVP) and other related activities performed by… more
    HireLifeScience (03/12/24)
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  • Merck & Co. (Rahway, NJ)
    …Continuous Improvement (QCI) colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance ( PV ), Global Regulatory Affairs and Clinical ... Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide the safety...acting as the link between Clinical Development, study teams, global business functions and regional study management. In collaboration… more
    HireLifeScience (05/29/24)
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  • Pharmacovigilance Scientist, Senior

    Amgen (Washington, DC)
    …million patients worldwide. It's time for a career you can be proud of. ** Pharmacovigilance Scientist, Senior Manager** **Live** **What you will do** Let's do ... one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products… more
    Amgen (05/25/24)
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  • 安全管理(ファーマコビジランス)業務従事者/ Senior Specialist,…

    Mallinckrodt Pharmaceuticals (Jobe, MO)
    …Kobe Job Description 医療用医薬品の安全管理業務を中心に担っていたいだくポジションです。担当いただく製品は国内外で販売されており、当該医薬品の個別症例情報・文献情報の取扱いとそれらに関連する業務を中心に担っていただきます。業務にあたっては Global PV ... 規制当局対応等に関する業務 + 定期報告等の安全性情報管理に係る各種文書作成 + 安全性データベースからのデータ抽出、抽出されたデータの集計分析 + 規制当局からの製品の安全性に係る照会事項への対応 + 潜在的な問題又はシグナルに注意を喚起することにより、製品の安全性プロファイルのモニタリングにおいて Global PV チームに必要なサポートの提供 規制等遵守のための管理・対応等に関する業務 + 文書及び記録の保管・管理 +… more
    Mallinckrodt Pharmaceuticals (05/10/24)
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  • Senior Director, Head of PV Quality…

    Daiichi Sankyo Inc. (Basking Ridge, NJ)
    …as other research areas centered around rare diseases and immune disorders. **Summary** The Senior Director, Head Global PV Quality (DSI/DSE) reports to the ... of direct reports (Directors, Associate Directors, Managers, contractors as applicable) across the Global PV Quality teams located in Europe and the Americas.… more
    Daiichi Sankyo Inc. (06/02/24)
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  • Director, PV Quality Oversight AI Lead

    Pfizer (Tampa, FL)
    **ROLE SUMMARY** The PV AI Quality Oversight Lead is responsible to oversee the strategic development and implementation for the quality plans, establishing ... ensure the quality and reliability of AI systems that may affect pharmacovigilance . This involves contributing to and participating in various quality oversight… more
    Pfizer (05/31/24)
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  • Senior Manager, Global Patient…

    Regeneron Pharmaceuticals (Sleepy Hollow, NY)
    **Overview:** This position is to support the Global Patient Safety (GPS) department in business support of safety systems utilized for pharmacovigilance . This ... issues of diverse scope + Liaise closely with the Global Development Solutions (GDS) / IT team and managed...directly or through existing platforms + In-depth knowledge of PV periodic reporting (eg. DSUR, PBRER, etc.) + Working… more
    Regeneron Pharmaceuticals (05/14/24)
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  • Senior Director, Global Patient…

    Regeneron Pharmaceuticals (Basking Ridge, NJ)
    Reporting to the Global Patient Safety (GPS) Therapeutic Area (TA) Head, the Senior Director, serves as the first point of contact (POC) for all safety related ... and influence colleagues in a matrix environment within and external to GPS including senior management. **In this role, a typical day might include:** + This Sr.… more
    Regeneron Pharmaceuticals (04/24/24)
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  • Senior Quality Assurance Specialist

    Astrix Technology (Jersey City, NJ)
    …work is started to draft revisions. + Review change control documents to ensure Global PV business process owners are considering proper training as a part ... Senior Quality Assurance Specialist Quality Assurance Jersey City,...Pay: $40-$45 per hour Type: Contract **Responsibilities** + Advise global pharmacoviligence teams on change control of procedural documents… more
    Astrix Technology (05/22/24)
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