Safety Evaluation

2ヶ月前


Akasaka, Tokyo GSK

Site Name:
Japan - Tokyo - Akasaka

Posted Date:
Sep

安全対策の検討と実行を主軸として、製品ライフサイクルを通して被験者・患者さんの安全性の確保に貢献する。

承認に向けてGSK Japanが遂行する開発プロジェクトを成功させるべく、クロスファンクショナルに活動する。治験において、治験参加者の安全を確保する試験計画を立て、得られた安全性データを適切に監視し、Global Safetyの方針に沿ったリスク対策を講じる。治験等で得られたデータに基づき、日本の医療環境を考慮したリスク管理計画を立案し、承認取得に貢献する。

承認取得後は、GSK Japanが承認取得した医薬品(Pharma製品、Vaccine製剤)及び医療機器を、医療従事者及び患者さんが常に安全・安心・適正に使用できるように、実臨床下で使用された際に得られる安全性情報及び関連する情報に基づき安全対策をGlobal Safety/Medicalチームと議論し立案・実行・効果検証を行う。また、臨床研究等Evidence generationにおいても参加者の安全確保に貢献する。

  • Human Subject Researchにおいて、患者の安全を考慮し、必要な安全性情報が得られるように臨床試験を計画し、得られた情報を安全対策に活用する。

  • 治験(試験)実施計画書、治験薬概要書、患者同意説明文書の作成・レビューを含む申請準備チームへの参画

  • Dear Investigator Letterなど重大なリスクへの対応

  • Global Safetyや国内関連部署と連携して申請資料を作成し、承認を取得するために照会事項に対してPMDAと協議する。

  • Global Safetyや関連部署との申請スケジュールの確認、協力要請

  • 医薬品リスク管理計画(RMP)の作成(日本におけるリスク特定、資材の立案を含む)及び照会対応
  • 電子添文の使用上の注意の作成及び照会対応
  • GCP適合性調査

  • GSK製品の安全対策の立案及び実施(リスクマネジメント):上記評価・分析結果及び医療環境等の外部環境を勘案した、医療従事者及び/又は患者さん向けの安全対策を立案・実施し、その効果を検証する。

  • 医薬品リスク管理計画(RMP:Risk Management Plan)の作成及び維持管理

  • 市販直後調査[EPPV]の企画及び報告書の作成
  • 医療従事者向け情報提供資材の作成、患者向け情報提供資材の作成
  • 電子添文(使用上の注意)の改訂とお知らせ文書の作成
  • 資材の作成・提供等を含む安全対策の立案(必要に応じて医療従事者との面談含む)
  • 実施した安全対策の効果検証

必要な条件Basic Qualification
スキル Skill
スキル

  • 医学・薬学に関する基本的知識とPV及びGCP/GVP関連規則等の理解・習熟
  • コミュニケーションスキル(当局・他社・外部専門家・社内他部署等の国内外関係者と折衝ができる交渉力)
  • データに基づいた論理的な文書作成能力
  • 自己管理能力(タスク管理、スケジュール管理が出来る方)

経験

  • 医薬品開発、安全対策業務(治験安全性業務、RMP作成、集積検討、安全性定期報告、再審査申請、市販直後調査等)に関する経験を3年以上有する:これらの経験が全て必須というわけではないが、治験安全性業務の経験があればより望ましい

学位/資格/語学力

  • ライフサイエンス系学位 学士以上

英語力中級以上(海外担当者とのメールコミュニケーション、海外文献の読解が出来るレベル、英語に対する苦手意識がないこと)

望ましい条件 Preferred Qualification
スキル

  • 数名又はプロジェクトのリーダー経験
  • 経験海外ステークホルダーとの業務経験
  • 抗癌剤の承認申請、抗癌剤の市販後安全対策の経験

学位/資格/語学力

  • 英語中・上級(海外担当者と口頭でコミュニケーションができるレベル)

**Why GSK?

Uniting science, technology and talent to get ahead of disease together.**
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.


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