- 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)
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