Safety risk management Manager
Tokyo, Japan Permanent Date posted Oct. 28, 2024■職務内容：
医薬品の安全性に関するリスクを管理し、以下のPV活動を通じて、製品のベネフィット/リスクバランスの最適化に貢献します。
・安全性データの正確かつ迅速な分析に基づく予防的な安全対策の実施
・社内外のステークホルダーとの協働による医薬品リスク管理の実施
・重要な安全性シグナルのタイムリーな検出および評価
・製品の安全性検討事項に基づく、規制当局およびグローバルPVとの緊密なコミュニケーション
・必要なリスク最小化活動の計画と実行をプロアクティブに行う
・臨床開発段階から市販後まで、エビデンスに基づく質の高い安全性分析と評価を一貫して行う
■主な業務内容：
・J-RMP（医薬品リスク管理計画書）の作成、改訂
・リスク最小化策の計画・実施・評価（医療関係者向け資材、患者向け資材、情報提供等）
・EPPVの計画、管理、規制当局への報告
・文献・海外措置情報の評価、規制当局への報告
・安全確保措置の立案（使用上の注意改訂の立案、等）
・安全確保措置実施の計画・管理・報告書作成（情報提供等）
・規制当局とのコミュニケーション(照会事項対応)
■必要なスキル：
・医薬品に関する科学的知識およびデータ分析スキル
・プロジェクトマネジメント/タスク管理スキル
・日本語（必須）、英語（ビジネスレベル）でのコミュニケーション能力
・規制要件を含むファーマコビジランス活動に関する知識
Job summary：
Manage safety risks and contribute to optimizing the benefit / risk balance of our products through the following PV activities
・Execution of proactive safety measures based upon accurate and prompt analyses of safety data
・Implementation of risk management for our products in conjunction with stakeholders
・Detecting and evaluating important safety signals timely
・Close communication with health authority and GPV based upon safety specification of our products
・Planning and execution of necessary risk minimization activities proactively ・Consistent and high-quality safety analysis and evaluation from clinical development phase to post marketing phase
Skills:
・Scientific knowledge about pharmaceuticals and data analysis skills
・Project / task management skills
・Communication skills in Japanese (required for communicating with HA) and English (business level)
・Knowledge of pharmacovigilance activities including regulatory requirements (GVP, GCP)
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