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Himalayas

Associate Medical Safety Director

United StatesPosted 1 day agoVerified about 18 hours ago

About This Gig

Job Title: Associate Medical Safety Director Job Location: Tokyo, Japan Job Location Type: Home-based Job Contract Type: Full time Job Seniority Level: Grade：１６０【部署】 Safety 部門日本拠点のMDは現在4名。現在増員でもう1名募集中。このポジションは日本のチームをまとめていただくリーダーポジションです。レポートはグローバルになります。（日本語）治験または市販後、安全性に関する医学的アドバイス有害事象・副作用入力情報を見て新規・既知の判断や、追加収集情報の依頼文献評価のサポートなど医学的アドバイス研究措置報告の評価領域としては、メジャーな低分子医薬品よりも抗体医薬・生物製剤が多くを占め、オンコロジーやオーファン領域のプロジェクトが多い【必須要件】日本の医師免許（履歴書に忘れずに記載ください）企業経験は必須としていないが、リモート環境でも柔軟に対応できる、適応能力は必要ですリーダーシップ、マネジメントスキル英語力：ビジネスレベル日本語力：ビジネスレベル以上、十分にステークホルダーとコミュニケーションが取れるレベル【尚可】 CROやメーカーで経験のある先生（安全性の経験は必須ではない）企業経験（English ） Essential Functions • Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary • Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requi

Skills & Tags

Pharmacovigilance Drug Safety Medical Director Medical Affairs Physician

About the Seller

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