Tokyo Alcon
【本ポジションのミッション】

日本の医薬品・医療機器法に基づくGVP省令関係業務、安全管理情報のグローバルからの要求事項に対する業務、安全管理情報の収集・評価を通し、アルコン社の医薬品・医療機器・医薬部外品の適正使用を通して安全性を確保する。

【役割】

医薬品・医療機器法に基づくGVP省令関係業務、グローバルの要求事項に沿った安全管理情報のハンドリング。

【業務詳細】

薬機法対応(GVP関係業務):医薬品、医療機器(クラス1~3)、医薬部外品

・安全管理情報(医療関係者、一般消費者、論文等、行政、調査等からの安全性情報)の収集、評価(他部門とのコミュニケーションあり)

・安全管理情報に対する措置の立案・実施(規制当局への不具合等の報告等)

・安全管理情報に関する記録の保存・教育訓練

・内部監査・外部監査対応業務

・海外アルコン担当者や海外ベンダーとのやりとり(英語)

【応募資格】

・ 理系の大学課程修了者(医療、生物等なら尚可)

・ グローバルとの英語でのコミュニケーション(メール等)が可能な方。

安全管理業務に興味がある方

・ 薬機法等の規制要件について基礎的な知識を持っている方(GxP関係業務経験者尚可)

・ レポート作成能力(行政向け等の報告書作成経験があると尚可)

・ チームで協力して仕事を進めていける方

・ 物事を論理的に考えられる方

・ 自身の専門分野以外でも新しい知識の習得を楽しめる方

・ 他部門と電話(社内)等での円滑なコミュニケーションが可能な方

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