Pharmacovigilance(Vaccine)

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
ワクチンに関する下記業務：
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
新医薬品の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
添付文書、J-RMP改訂に関する、PMDA、本社及び 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
厚生労働省が開催する部会、調査会への安全性情報提供
ワクチン定期接種化を目的とした部門横断的活動への協力

The following tasks related to vaccines
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 "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
•　Provide safety information to the committees held by MHLW
•　Cooperate with in-house cross functional team for inclusion of vaccines in the national immunization programs

Requirements
薬学又は医学に関する基本的知識
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
安全性業務を取り巻く環境変化が大きいなか、それを楽しめるマインド

望ましい：
薬機法、G CP、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
ワクチン領域の国内規制に関する知識
医薬品又はワクチンの開発業務への従事経験

Prerequisite:
Basic knowledge about pharmaceutical and/or medical sciences
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
Mindset to enjoy significant environmental changes surrounding safety work

Preferred:
Basic knowledge about domestic and overseas regulations related to safety-related duties, such as the Pharmaceutical Equipment Law, GCP, GVP, GPSP, etc.
Basic knowledge in local vaccine regulations
Experience in drug and/or vaccine development

Nhật BảnTokyo Bản đồ

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