Specialist, Pharmacovigilance(Oncology)

Company Overview
大手外資製薬メーカー/オンコロジー領域へ注力/福利厚生充実

Job Description
オンコロジー領域の医薬品に関する下記業務：
- 開発品安全性業務
- 開発段階からの市販後安全対策の立案
- 申請時添付文書「使用上の注意」、J-RMP（安全性検討事項、安全性監視計画、リスク最小化策）の立案、作成
- CTDの安全性パート作成、審査対応
- 最適使用推進ガイドライン、使用上の注意の解説の作成・改訂
- 市販品安全性に関する集積検討、安全対策の立案
- 安全性シグナルの検出
- 添付文書、J-RMP改訂要否検討及び改訂案作成
- 添付文書、J-RMP改訂に関する、PMDA、本社及び国内他社等との交渉／相談
- その他安全対策の検討、適正使用資材の作成
- 安全性定期報告書及び再審査申請資料の安全性パート作成

その他:
- 市販後安全対策全般に関する外部医学専門家とのコミュニケーション、各学会対応
- 医療従事者からの副作用問い合わせに対する回答作成

The following tasks in Oncology Safety area:
- Conduct safety tasks for Investigational Drugs
- Plan post-marketing safety measures from the development stage
- Prepare "Precautions" in the local labeling and "Safety Concerns, Pharmacovigilance Plans, and Risk Minimization Measures" in the J-RMP for local New Drug Application (J-NDA)
- Prepare safety sections of the Common Technical Document (CTD), and respond to regulatory review
- Prepare and revise "Optimal Clinical Use Guidelines" and "Explanation of Precautions of New Drugs"
- Review aggregate safety information of marketed products and discuss/perform safety measures
- Detect safety signals
- Examine the necessity of revisions of local labeling and J-RMP, and prepare revised documents
- Negotiate/consult with PMDA, HQ, and other business partners on revision of local labeling and J-RMPs
- Discuss other safety measures and prepare materials for proper use
- Prepare safety part of local Periodic Safety Update Report and Reexamination Application dossier

Others:
- Communicate with external medical experts and academic societies on overall post-marketing safety measures
- Respond to inquiries from healthcare professionals on adverse reactions

Requirements
必須：
抗がん剤、オンコロジー領域に関する医学的知識
社内（国内・外）関連部門、規制当局、外部医学専門家と良好な関係を築くことができるコミュニケーションスキル、協働、交渉するスキル
問題の本質をとらえて適切な対策をとれる分析力、解決能力
海外との日常業務ができるレベルの英語力
業務を行うためのITスキル

望ましい資質：
薬機法、GCP、GVP、GPSP、等安全性業務関連の国内外の規制に関する基礎知識
オンコロジー領域の安全性業務経験

Prerequisite:
Basic knowledge about medical science in anti-cancer drugs and Oncology area.
Communication, collaboration, and negotiation skills that can build good relationships with relevant internal departments (in and outside Japan), regulatory agencies, and external medical experts
Ability to analyze and resolve problems, and take appropriate measures by identifying essential problems
English skills to perform daily work with overseas divisions
IT skills to perform daily work

Preferred qualities:
Basic knowledge about domestic and overseas regulations related to safety-related duties, such as the Pharmaceutical Equipment Law, GCP, GVP, GPSP, etc.
Work experience in Oncology safety area

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