Safety Assurance Specialist job opportunity at Abbott.

Home Jobs In Japan Tag: Job Safety Assurance Specialist position at Abbott


DateMore Than 30 Days Ago bot
Abbott Safety Assurance Specialist
Experience: General
Pattern: full-time
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degreeGeneral
loacation Japan - Tokyo, Japan
loacation Japan - Tokyo....Japan

      JOB DESCRIPTION: CORE JOB RESPONSIBILITIES GVP関連、行政報告における行政や他社に対する窓口となり対応を行う。 GVP関連、行政報告の法規制を適切に導入する。 安全管理情報及び必要な情報を収集し、評価、検討し、安全確保措置を立案する。 不具合、外国措置、回収報告等の行政への報告書を作成し、期限内に提出する。 安全確保措置の進捗を管理し、完了を確認する。 安全確保業務に関する記録を作成し保管する。 GVPの観点より、添付文書、表示材料、カスタマーレター等を確認する。 薬事申請におけるSTED用安全性データを提供する。 担当業務の進捗状況を上長へ報告する。 上長、他のメンバーと協調して業務を行う。 その他、上長より指示された業務を遂行する。               MINIMUM SKILLS REQUIRED 技術文書・わかりやすい報告書の作成能力 論理的思考力 業務上のコミュニケーションができる英語力 KNOWLEDGE / EDUCATION REQUIRED 薬学・化学・生物学・工学専攻の大卒者、又は同等の実務経験と知識のある者 製品の学術的知識、臨床的知識、基本性能に関する知識 EXPERIENCE REQUIRED 安全管理、品質保証、薬事、臨床開発部門における1年以上の職務経験、又は同等の職務経験（Grade 12を除く）       The base pay for this position is N/A In specific locations, the pay range may vary from the range posted.       JOB FAMILY: Quality Assurance       DIVISION: AVD Vascular          LOCATION: Japan > Tokyo : Mita South Tower       ADDITIONAL LOCATIONS:       WORK SHIFT: Standard       TRAVEL: No       MEDICAL SURVEILLANCE: No       SIGNIFICANT WORK ACTIVITIES: Not Applicable                  

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