外資系製薬メーカーでPharmacovigilance Managerとして働きます。PVの経験を活かしてキャリアアップし、自社の医薬品開発に携わることができます。 · GVP、GPSP、GCPおよび関連する規制要件ならびにSOPを遵守し、市販製品および治験薬に関する適切なPV活動 · 国内外の個別症例報告(ICSR)の評価および報告に関する全体管理 · 国内外の研究報告ならびに海外で講じられた安全対策の評価および報告に関する全体管理 · ...

クイ（ja）２！ · ﾝ · ...

グローバルと連携しながら、日本国内のPV業務をリードできるポジションワークライフバランスを重視し、柔軟な働き方が可能企業情報世界的に事業を展開する製薬企業で、皮膚疾患や希少疾患領域に強みを持ち、患者安全を最優先に革新的な治療法を提供しています。職務内容市販品および治験薬の安全性情報の評価・報告国内外の症例報告や調査結果の管理リスクマネジメントプランの作成・更新PV関連の監査・査察対応グローバルチームとの連携、規制当局対応GPSP関連業務(再審査・使用成績調査など)理想の人材PV業務での実務経験(3年以上)必須GVP、GPSP、GCPに関する知識ビジネスレ ...

医療機器・医療品関連の製品ライフサイクルを支援する、高品質かつ規制要件に準拠した臨床文書を作成(指導の下) · ...

臨床文書を作成し、規制要件に準拠した文書を手配します。 · 新たなデジタル技術やAIソルーションについて学び、新しいプロセスを導入します。 · ...

マーケティングマネージャー《複数ブランドの統括をご担当◆週2~3日のリモートワークOK》 · ※意思決定の速い少人数組織にて、グローバルと連携しながら複数ブランドを戦略的にマネジメントし、ブランド成長に直接貢献いただける裁量の大きなポジションです。 · ブランド戦略の立案・実行、市場目標との整合性確保 · 統合マーケティング施策の計画・管理(ATL/BTL、デジタル、PR、消費者施策) · カテゴリー収益性・パフォーマンスのモニタリング、成長機会の特定 · P&L管理、予算配分・投資効果の追跡 · 新製品開発・市場投入プロジェクトの管理、価格戦略の支援 ...

連이는 최일을 현로대패 입해카재 , 머주요 멁호 2023-07-26. · ...

+ 10 years' practical experience with CMC-related roles preferred (CMC regulatory affairs, Analytical/Quality testing, or Manufacturing) in Pharma Industry Advanced degree in medical, pharmaceutical or life-science etc Hard skills/ Expertise: Idealy + 10 years' practical experien ...

Lead and manage CMC regulatory activities including relevant cross-functional communication, providing guidance across the product lifecycle, and ensuring timely regulatory compliance with official guidelines. Develop and implement CMC registration strategies related to CTNs, NDA ...

We put the diversity of our employees as a source of richness for the fulfillment of this vocation. · 製造委託先との製品に関する連携、技術移管及び移管後の維持管理を含む · ...

Show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections. · ...

Finance & HR Generalist to contribute to the company's growth in Tokyo. · Handle daily and month-end accounting activities and prepare profit & loss statements and Balance Sheet. · Manage treasury, including control of vendor invoice and employee expense, payment execution, and p ...

Are you ready to accelerate your potential and make a real difference within life sciences, · diagnostics and biotechnology? · ...

We're looking for a Field Scientist who can work with our clients in hospitals and testing centers across Japan to provide support and training on our products. · ...

Internal Audit Manager is responsible for leading internal audit activities in Japan, focusing on US-SOX compliance. The role involves developing and improving the internal audit and control system, designing and improving audit methodologies, and evaluating and documenting inter ...

We are seeking a strategic business leader to drive growth for a leading healthcare solutions provider in Japan. This role offers the opportunity to shape the business unit strategy, lead cross-functional teams, and build strong partnerships with pharmaceutical clients and key st ...

Leveraging the latest insights in pharmacokinetics (PK) and pharmacodynamics (PD), we apply advanced kinetic analysis to drive efficient drug development, regulatory registration and maximize compound value. · ...

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? · At Pall Corporation, one of Danaher's 15+ operating companies, our work saves lives—and we're all united by a shared commitment to inno ...

We're an R&D-driven AI-powered biopharma company committed to improving people's lives and delivering compelling growth. · We chase the miracles of science to improve people's lives. · Sanofi provides equal opportunities to all regardless of race,color ancestry religion sex natio ...

Bring more to life. · Are you ready to accelerate your potential and make a real difference within life sciences, · diagnostics and biotechnology? · At Pall Corporation, · one of Danaher's 15+ operating companies, · our work saves lives—and we're all united by · a shared commitme ...

We are expanding our sales team to accelerate product penetration through appropriate information delivery to healthcare professionals and strategic area-based activities. · ...