- 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
- 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Senior Specialist, Clinical Literature MonitoringProvides pertinent and timely information on our Company's products and ... search request results meet current regulatory requirements Collaborates with pharmacovigilance teams to meet current literature-related adverse event monitoring… more
- 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
- BeiGene (San Mateo, CA)
- …the Following Activities:** ** Global PE Strategy** + Develop and implement a Global PE strategy **Develop and Implement PV -Epi Research Program for Safety ... Description:** _Provide leadership in observational research and influence BeiGene's global strategy to integrate epidemiology into the new drug development… 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
- 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
- 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
- AbbVie (North Chicago, IL)
- …including organization, resources operations and continuous improvement efforts. Supports Directors/ Senior Directors, Global Pharmacovigilance by providing ... for AbbVie, ensuring service-level targets are met or exceeded. . Supports Global Pharmacovigilance MedDRA group (responsible for medical terminology coding… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- Reporting to the Global Patient Safety (GPS) Therapeutic Area (TA) Head of General Medicines, the Senior Director is a key role that contributes to the success ... the ability to work with and influence colleagues of all organizational levels, including senior management, in a matrix environment. **This role might be for you if… more
- 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 (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
- 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
- Merck (North Wales, PA)
- **Job Description** **Position Description:** Senior Specialist, Clinical Literature Monitoring Provides pertinent and timely information on our Company's products ... request results meet current regulatory requirements + Collaborates with pharmacovigilance teams to meet current literature-related adverse event monitoring… more
- Boehringer Ingelheim (St. Joseph, MO)
- …and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering ... programs reflect Boehringer Ingelheim's high regard for our employees. The Senior Clinical Research Associate (SCRA) conducts in-house and external monitoring to… more
- Astellas Pharma (Northbrook, IL)
- …interested in remote work are encouraged to apply. **Purpose and Scope:** The Senior Manager Study Operations will mainly be asked to manage less complex studies, ... accordance with GPSP regulations and company procedures. Cooperate with PV /RA to prepare the study plan as a part...Collaborate within M&D: + Development + Regulatory Affairs + Pharmacovigilance + Collaborate with divisions outside of M&D: +… more
- J&J Family of Companies (Horsham, PA)
- …the Pharmaceuticals Chief Medical Officer (CMO), the Qualified Person for Pharmacovigilance (QPPV) Pharma, Senior Management, Health Authorities (HA), ... responsible for product safety and benefit risk oversight and represents Global Medical Safety (GMS) as the product spokesperson regarding overall benefit/risk.… more
