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Principal Drug Safety Associate

  1. Japan
2024-109903
  1. Drug Safety
  2. ICON Strategic Solutions

About the role

This vacancy has now expired. Please click here to view live vacancies.

・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。


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（入力、評価、当局報告書作成等）の実施、業務管理、3～10名程度のメンバーのリード業務および関連付随業務を担当いただきます

下記のような業務を想定しております。
・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、必要に応じマニュアルの作成等を担当する
・GVP、SOP を遵守した安全性個別症例評価業務に精通し、他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提案する
・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　
・社内およびクライアントのプロジェクトチームのミーティングに参加し、キックオフミーティングやプロジェクトミーティングでのプレゼンテーションなどを行う。
・ Drug Safety Associateのリーダーとして、プロジェクトレベルでチームの窓口を務める
・経験の浅いメンバーの育成指導、派遣社員の管理等


・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）

List #1

Day in the life

A picture of a pipette next to some drugs
What does a Drug Safety Associate (DSA) do?

Teaser label

Inside ICON

Content type

Blogs

Publish date

09/29/2022

Summary

A Drug Safety Associate is responsible for assessing the safety of pharmaceuticals drugs once they’re on the market. Using standardised guidelines, they determine whether the medication causes any adv

Teaser label

A Drug Safety Associate is responsible for assessing the safety of pharmaceuticals drugs once they’re on the market.

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