メディカル・バイオ - 安全性情報（臨床開発・製販後GVP）

安全管理責任者や市販後調査責任者の代理を務めます。
主な業務は、GxP関連業務を担う外部サービス提供者の管理、J-RMP（リスク最小化計画）の策定・運用、J-NDAや年次報告書への貢献です。また、調査中および市販製品の安全性管理、CROのパフォーマンス監督、PMDA対応、品質・コンプライアンスの継続的改善、各種年次報告書の作成支援も担当します。

■休日：完全週休二日制, 土, 日, 祝日, 年末年始

JOB REQUIREMENTS:
Education
- Bachelor's degree (advanced degree preferred)

Experience
- More than 8 years’ experience in Pharmacovigilance and PMS operations
- Well informed on relevant PMDA/MHLW and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required.
- Demonstrates the ability to collaborate with cross-functional teams such as Medical Affairs, Regulatory Affairs, Sales, Marketing and clinical development.
- Experience leading regulatory authority inspection such as PMDA Re-examination, MAH license renewal and GCP Reliability Inspection.
- Experience managing complex projects, such as function/team improvement projects, Safety Database implementation projects, Business license succession including safety data migrations.
- Experience supporting the J-RMP, JPI establishment and maintenance, and drafting Japan annual reports (i.e. J-DSUR, J-PSUR) and re-examination dossier.
- Over 8 years Pharmacovigilance/Drug Safety experience including case processing and PMS in the pharmaceutical / biotech industry required.
- Experience with vendor selecting, managing external service providers which have been entrusted with GxPs operations (GCP/GVP/GPSP) on pharmaceutical products, regenerative products and medical devices.
- Prior global pharmacovigilance experience

■職種未経験者：不可