Senior Specialist, Clinical Safety job opportunity at Edwards Lifesciences Corporation.

Home Jobs In Japan Tag: Clinical Safety Senior Specialist, Clinical Safety position at Edwards Lifesciences Corporation


DateMore Than 30 Days Ago bot
Edwards Lifesciences Corporation Senior Specialist, Clinical Safety
Experience: General
Pattern: full-time
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Clinical Safety

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degreeGeneral
loacation Japan-Tokyo, Japan
loacation Japan-Tokyo....Japan

エドワーズライフサイエンスは、構造的心疾患の領域において、患者さんを中心にした医療イノベーションの世界的リーダーです。世界 100 カ国以上で数百万人の患者さんに医療技術を提供し、治療アウトカムの向上や、医療的アンメットニーズに対する持続的なソリューションを創出することに全力を注いでいます。 ■職務内容 国際共同治験（製販後臨床試験を含む）における医療機器（ TAVI ：経カテーテル大動脈弁置換術）の治験安全性業務全般 ・ GCP 省令に準じた有害事象・不具合情報の収集・評価 ・ GCP 省令に準じた当局への有害事象・不具合報告業務（研究報告・外国措置報告含む） ・治験施設への安全性情報報告用資料の作成 ・医療現場担当者（モニター /CRA ）への各種問い合わせ対応 ・ Global の関係部門ならびに関係ファンクションとの調整・連携業務 ・治験安全性関連手順書の管理・改訂 ・治験関係者・施設への安全性関連トレーニングの実施 ・治験安全性業務に関連する各種データ集計   ■応募要件 PC スキル（ Word, Excel, PowerPoint etc. ） Clinical Safety 業務の 5 年以上の経験（製薬・医療機器不問）、または Clinical Safety 業務 3 年以上かつ市販後安全管理業務 2 年以上の経験 英語読解力（ TOEIC 700 以上） 仕事の正確な方 革新的医療機器の安全性を牽引してゆく責任感のある方 循環器または心臓関連製品・疾患の知識がある方歓迎 医療機器に関する経験がある方歓迎 英語でのビジネスコミュニケーション（メール・会議）が可能な方歓迎

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