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Pharmacovigilance Associate

  1. Osaka, Tokyo
JR116289
  1. Drug Safety
  2. ICON Full Service & Corporate Support
  3. Hybrid: Office/Remote

About the role

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、またご経験に応じて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。 
 
【その他の業務】
・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

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.

Read more
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Who we are

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