Jobs at Parexel
Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Drug Safety Associate / 治験薬 / 市販後薬品に係る安全性情報スタッフ
Job ID R0000029275 Tokyo, Tokyo, Japan■職務内容
薬機法や安全性に関する規制及び社内の標準操作手順(SOP)を遵守し、国内外の医薬品、医療機器、
再生医療等製品に関する有害事象、副作用情報、不具合情報の収集、評価、報告を行う業務です。
具体的には下記の業務です
・国内における治験薬・製造販売後製品の安全性情報、文献学会の一次評価
・CIOMSや文献学会情報等による海外(英語)安全性情報の一次評価、和訳
・MRへの再調査指示業務サポート
・医薬品医療機器総合機構への(医薬品)副作用、研究報告、措置報告、不具合報告書(案)の作成
・経験に応じて、チームリーダーやクライアント窓口などを担当していただくこともあります。
・その他、クライアントの指示命令事項
■必要条件
・治験薬 or 市販後薬品に係る安全性関連業務経験2年以上された方。
・業務において英語を使用されている方
・Argusの使用経験
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