- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director, Pharmacovigilance ( PV ) Operations in Cambridge, MA, where ... marketing services. As part of the Patient Safety & Pharmacovigilance (PSPV) team you will report to the Executive... regulatory requirements and to drive improvements in Takeda global PV processes. + Ensure overall performance… more
- Merck (Rahway, NJ)
- …and regulations across the globe. We do this by ensuring compliance of the company's pharmacovigilance system with global PV requirements as well as ensuring ... long-term goals. We support our mission by ensuring that pharmacovigilance ( PV ) activities carried out by our...safe and effective use of our medicinal products. The Global PV Quality Assurance intern will have… more
- 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
- Merck (North Wales, PA)
- …long-term goals. The Global Regulatory Affairs and Clinical Safety (GRACS) Pharmacovigilance ( PV ) Business System Management and Innovation team is seeking a ... and will be assigned to lead a variety of process improvement projects within the PV Business System Management and Innovation team in support of PV business… more
- Merck (Rahway, NJ)
- …long-term goals. The Global Regulatory Affairs and Clinical Safety (GRACS) Pharmacovigilance Partner Strategy & Management ( PV -PSM) team is seeking a summer ... and will be assigned to lead a variety of process improvement projects within PV -PSM in support of business development and vendor deals with various partners. The… more
- Takeda Pharmaceuticals (Boston, MA)
- …within the Risk Management and Education function, you will report to the Senior Director, Signal Management and represent the pharmacovigilance department as ... life-changing therapies to patients worldwide. Join Takeda as a Associate Director, Global Patient Safety Signal Management and Innovation in Cambridge, MA, where… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …that we believe will guide and lead all aspects of quality and compliance within global pharmacovigilance ( PV ) system. We expect the Sr. Manager to build ... and liaise with multiple cross-functional collaborators whose work impacts the Regeneron global PV system, including but not limited to: Global Patient… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Manager, Aggregate Safety Reporting in Cambridge, MA, where you will be ... high- quality aggregate safety reports, in compliance with requisite global and local regulations and requirements. As part of...and requirements. As part of the Patient Safety & Pharmacovigilance (PSPV) team, you will report to the Director… more
- Gilead Sciences, Inc. (Foster City, CA)
- …in Patient Safety cross-functional teams. + Communicates to highest levels of senior management key pharmacovigilance findings. + Oversees or performs medical ... of the drug development process, Good Clinical Practices (GCP) and Good Pharmacovigilance (GVP), including worldwide PV regulations and their application to… more
- Bristol Myers Squibb (Princeton, NJ)
- …Safety Assessment (MSA) TA Head/Lead in developing and maintaining state-of-the-art Pharmacovigilance ( PV ) processes and procedures within BMS Drug Development ... is responsible for ensuring the safety of our medicines. WWPS pharmacovigilance and pharmacoepidemiology deliverables include single case and aggregate safety… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …Information (RSI) approvals by global health authorities, and tracking for Global Pharmacovigilance ( PV ) Planning Team. Additional responsibilities may ... eCTD, IDMP, UDI, etc). + Knowledge and practical experience in managing global Clinical Trial Applications (eg IMPD) preferred + Knowledge of pharmaceutical drug… more
- BeiGene (San Mateo, CA)
- …report significant investigation / deviation issues and system deficiencies to senior management, as appropriate + Manage internal training program and coordinate ... GCP Inspection Management Team for other inspection types (eg GLP/GLP and PV inspections) + Other duties as assigned **Supervisory Responsibilities:** + Ability to… more