- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …relationships (including global and regional leaders from Supply Chain, Clinical Safety Pharmacovigilance, Commercial, Medical Affairs and Legal) to ensure ... evolving global regulatory requirements and with company objectives. The Head of GRA Global Labeling leads a team of...to labeling-related questions during Health Authority inspections and partner PV audits. Review and ensure compliance with PV… more
- Sanofi Group (Bridgewater, NJ)
- ** Medical Safety Head , PV (CHC)** **Location:** Bridgewater, NJ, USA | Industriepark Hochst, Frankfurt, DE | Le Lab 157, Neuilly Sur Seine, FR **Remote ... the Global Head of Consumer Safety , the Medical Safety Head (TAH) provides PV expertise, leadership, mentorship, and supervision of involved … more
- Sanofi Group (Bridgewater, NJ)
- …CHC PV Operations Head . This position includes responsibilities of Case Medical Safety lead The position is the process owner for case management ... not limited to case management for marketed CHC products, safety medical evaluation, HA reporting, Product Technical...in clinical trial and marketed products + Knowledge of PV safety system management. Experience with LSMV… more
- Sanofi Group (Bridgewater, NJ)
- **Regional PV Manager** Internal posting title: Deputy Country Safety Head , US and Canada **Location:** Bridgewater, NJ **Remote Work:** Hybrid **Job Type:** ... of absence of the CSH). **Main Responsibilities** **The CHC PV Deputy** **Country Safety Head ...CSH + PV Zone Leads + Regional PV Head + Country Medical /Regulatory/Quality… more
- Boehringer Ingelheim (Athens, GA)
- …high regard for our employees. **Duties & Responsibilities** + Together with Head of PV Operations, establish and maintain scientifically valid ongoing ... **Description** The AD Global PV Data Analysis supports the Global Pharmacovigilance (...analysis of data sets as on adverse events for safety and efficacy purposes of our veterinary products. +… more
- J&J Family of Companies (Horsham, PA)
- Director, Medical Safety Officer, Oncology - 2406183977W...MSO will report to the GMS Sr. Director Product Safety Head , Oncology and oversee the ... **Description** Johnson & Johnson, is recruiting for a Director, Medical Safety Officer, Oncology to be located...to benefit/risk, when appropriate, to the Sr. Director Product Safety Head , the VP Therapeutic Area … 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 ... Serves as delegate as needed for GPS Therapeutic Area Head , Hematology + Proactively identify and develop safety...following:** + 5+ years of total relevant experience in PV and/or relevant medical field with PharmD… more
- AbbVie (South San Francisco, CA)
- …the strategy for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans, ... that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a...component + Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents… more
- Mallinckrodt Pharmaceuticals (Jobe, MO)
- …GVPに基づく安全性情報の処理 + 入手した安全管理情報の処理（評価・安全性データベースへの入力・評価資料の作成・フォローアップ等）: 使用する安全性データベースはGlobal safety databaseであり、入力言語は英語 + 安全性評価／安全対策に係る案件に関する当社Global ... 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 + 自己点検の実施・報告 + 関連する PV… more
- J&J Family of Companies (Horsham, PA)
- … assessment of assigned products. The Manager SAS, in partnership with the Medical Safety Officer (MSO), is responsible for the preparation of scientific ... safety evaluations, including strategy discussions, collaborating with Therapeutic Area Safety Head (TASH)/MSO and other stakeholders as necessary, data… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …respected - is a research-driven pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and produced several ... treatments for difficult-to-treat diseases and commercializing products with significant unmet medical needs in North American markets. In the United States, MTPA… more
