【東京】PV(Pharmacovigilance Reporting Associate)CRA応募可◎ Job at ICONクリニカルリサーチ(同), 東京都

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  • ICONクリニカルリサーチ(同)
  • 東京都

Job Description

弊社のSafety Reporting Groupにて、医薬品の治験/製造販売後におけるPV業務をお任せいたします。

■有害事象、トリアージ、付番、内容確認、データベース/QC入力情報の
受領 ■症例経過説明文の作成(日本語、英語)/QC ■評価内容のPMDA/QCへの報告要否の一次評価 ■PMDA/QCへの報告作成 ■エスカレーション、調整など ■上記に付随する業務
※Safety Reporting Groupでは、単なるcase processだけにとどまらず、ICCC試験の立ち上げもご経験いただくことが可能です。 【いずれか必須】■PVの実務経験 (特に、PMDA submissionの経験、ICCCの経験があれば尚可。) ■CRAの2年以上の経験 ■ビジネスレベルの英語力

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