- Amgen (Washington, DC)
- …over 10 million patients worldwide. It's time for a career you can be proud of. ** Global Pharmacovigilance ( PV ) Senior Scientist - US Remote** **Live** ... Let's change the world. In this vital role the Global PV Senior Scientist will...**Basic Qualifications:** Doctorate degree and 2 years of safety/ pharmacovigilance experience OR Master's degree and 4 years of… 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
- Lilly (Indianapolis, IN)
- …implications for the Core Safety Information and Core Risk Minimization Activities, represent PV position to Global Patient Labeling Committee and/or the Safety ... better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees...people around the world. The purpose of the GPS Senior Medical Advisor/ Medical Advisor is to perform medical… 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
- Sanofi Group (Cambridge, MA)
- …provide treatment to patients with specific illnesses where treatment access is limited. ** Global Senior Manager - Governance & Risk Management** sits within ... programs management. + Significant experience in Medical Governance, Medical Quality, Pharmacovigilance , Regulatory Affairs, Medical Operations (at global and… more
- 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
- Boehringer Ingelheim (Athens, GA)
- …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) supporting Environmental Fate and Exposure… 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
- US Tech Solutions (Raritan, NJ)
- …Officer (OCMO) Senior Leadership Team * Office of the QPPV * Global Regulatory Affairs * International Pharmacovigilance Leadership * Other partners across ... when to ask for help - Working within the Global Environment / Global Teams - Regulatory...Related Experience: Minimum of 2 years of experience in pharmacovigilance case processing, aggregate reporting, and/or PV … 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
- Sanofi Group (Bridgewater, NJ)
- …on franchise related benefit-risk assessments/ recommendations in conjunction with pharmacovigilance , pharmacoepidemiology and clinical sciences teams + Senior ... From our beginning as a local French enterprise to our position as a leading global healthcare company, reinvention is in our DNA and reflects our quest to make life… more
- Sanofi Group (Columbus, OH)
- …frameworks for external and internal interactions and complete all global /local mandatory trainings. **Key Responsibilities:** **Scientific Engagement and Exchange** ... scientific support for internal functions such as commercial, market access, regulatory/ PV and R&D regarding scientific trainings and updates **Supporting Evidence… more