【業務内容】
複数名の安全対策グループメンバーを管理します。人材の採用・育成・担当業務の割り振り・業務管理・目標管理・勤怠管理に責任を持ちます。
安全管理責任者の指示のもと、製品出荷後の苦情・安全管理情報(品質、有効性及び安全性に関する事項その他医療機器の適正な使用のために必要な情報)を収集、検討及びその結果に基づく必要な措置(安全確保措置)を担当者に行わせ、また自らも実施します。
安全確保措置の実施にあたっては、責任と解決策を明確にするため、社内関係者(営業部、マーケティング部、オペレーション部、薬事本部、臨床開発部及び法務本部等)、業界団体及び行政関係者との調整を担当者に指示し、または自らも調整を行います。
苦情・安全管理情報の収集、検討及び安全確保措置の実施に必要なプロセス、手順及び管理方法の改善を図り、健全な状態に維持します。プロセス、⼿順及び管理方法を維持するため、苦情・安全管理情報の収集、検討結果をレビューし、必要に応じて担当者へのフィードバックをするとともに、当社製品の市場におけるパフォーマンスをモニターし、安全管理責任者へレポートし、問題解決のための是正措置を実施します。
苦情・安全管理情報を海外製造元と共有し、必要に応じて対策を協議します。
使用成績調査対象製品について、市販後安全性情報および安全確保措置の実施結果について担当者へ主管部門連携を指示し、使用成績調査対応の支援を行います。
各種プロジェクトに対して、安全対策グループとしてのリソース提供を検討、実行し、製造販売業者としてのコンプライアンスの維持を確実にします。
【必須経験】
5年以上の医療機器製造販売業者における製造販売後安全管理(GVP)業務経験(クラスⅣデバイスであれば尚可)
2年以上のマネージメント経験
関連諸官公庁(MHLW、PMDA、TMG)担当者との対応経験
都道府県庁、PMDA又は認証機関による査察対応
マトリックス組織でのプロジェクト対応
英語力(ビジネスレベル、電話会議可能)
【勤務地】
・本社(東京都中野区)
Boston Scientific
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