Manager, Drug Safety

3 weeks ago


Emelle Alabama, United States Pharmaceutical Research Associates, Inc Full time
Overview:
・成長性の高い両社の統合により、世界で1-2位を争う規模のグローバルCRO(世界で40,500名規模、日本で1,000名規模)に拡大・補完的な統合にもとづく、クライアントポートフォリオの多様化がもたらす本格的なスケールメリットの実現
・さまざまな疾患領域への深い知識をはじめとする、両社が育んできた強みを活かした幅広い/質の高いソリューションの提供・最先端のテクノロジーに、スケールメリットが加わることで、より患者さん中心の新しい臨床開発オペレーションを業界内で牽引
・ビジネス機会の拡大・多様化に伴う、従業員に対する幅広いキャリア・能力開発の機会を提供今後も業界内において、ますますの大きな変化(合従連衡や臨床開発のオペレーションそのものの変革)が予想されます。

Responsibilities:
ファーマコビジランス部門・PMSチームにて、安全性個別症例評価プロセス一連の業務を担うチームの管理職ポジションです。

下記のような業務を想定しております。
・プロジェクト業務が適切に行われていること、チームのパフォーマンス(品質、効率)等を管理する。安全性データベース及び業務に必要なシステムの運用を理解し、チームメンバーを指導する。
・GVP、SOP を遵守した安全性個別症例評価業務に精通し、メンバーを指導する。
・業務プロセス等に影響を与えうる問題への対処や改善点を把握し、チーム内外での意見をとりまとめて改善を遂行する。
・規制当局による適合性書面調査、クライアント監査等の準備、対応に協力する。 
・プロジェクトのチーム責任者として、社内およびクライアントとのコミュニケーションを取る。ビジネス会議等への参加、プレゼンテーション含む。
・チームメンバーの人事管理(工数、年間目標設定、人事考課等)
・メンバーの育成、指導、派遣社員の管理、採用活動等

こちらのポジションは約40名(正社員15名程度・派遣社員25名程度)のマネジメントだけでなく、顧客の対応・個別症例評価のノウハウをチームに発揮していただくことを期待しています。

Qualifications:
・医薬品業界ファーマコビジランス部門における安全性個別症例評価業務・入力業務・プロセッシングの一連の経験(3 年以上)と、これに基づく深い専門的知識
・関連する業務のチームリード、メンバーの育成指導、派遣社員の管理などを経験したことがある方
・CIOMS form 記載の個別症例報告や社内手順書等の文書(英語)を抵抗なく読解できる英語力
・メール、文書作成などの基本的な英語の対応が一人でできる方
・大学卒(同等の学歴または業界経験値)


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