安全评估与风险管理医师

職務の目的 SERMフィジシャンは、臨床開発や市販後におけるGSK製品の継続的な安全性評価やリスク管理に責任をもち、GSK Japanが販売している製品を使用する患者さんの安全/安心に寄与します。

規制要件を満たし、安全管理の取り組みを積極的に推進するために、有害事象などの安全性情報が効率的に評価されることを確実に実行します。

安全性の観点から日本の医薬品開発をサポートし、GSK日本法人やGSKグローバルの関連する部署に対して、医学的観点から安全性の意見やアドバイスを提供します。

Job Purpose: SERM Physician will provide responsibility for the continued safety assessment, evaluation and risk management of GSK Japan products in clinical development and/or the post-marketing setting. This contributes to keep patients using GSK Japan marketed products be safe. To ensure adverse event and other safety information is efficiently evaluated in order to meet regulatory requirements and drive proactive implementation of safety management initiatives. To support Japanese drug development from safety perspective and provides safety input from medical perspectives to relevant colleagues in GSK Japan and GSK Global. 主なアカウンタビリティ／レスポンシビリティ 患者さんの安全のため、製品のライフサイクルを通じた、リスク同定、リスク評価、リスク最小化活動の実施 製品の個別安全性情報や定期的な安全性情報の医学的レビュー 規制当局への提出文書や外部ステークホルダーへの配布文書の医学的レビューと品質の担保 日本の新薬承認申請に向けた安全性に関する規制当局との交渉への貢献 安全性関連の会議への参加 医学的観点から、日本の開発プロジェクトチームと共同で医薬品開発の安全性情報を能動的に投入 安全性部門に限らず、GSK日本法人やGSKグローバルの関連する部署に対し、医学的レビューと医学的アドバイスの提供 Key Accountabilities/Responsibilities (include but are not limited to the following): Medical review of individual case safety information and periodic safety data for products Perform risk identification, assessment and mitigation activities throughout product lifecycle for patient safety To medical review and ensure quality of the documents to be submitted to regulatory authority and/or distributed external stakeholders To contribute safety aspect for J-NDA and negotiating with regulatory authority Participation in safety-related meetings To input proactively safety information on developing drugs with Japan project team from medical perspectives Medical review and provide medical advice on safety-related aspects to relevant colleagues in GSK Japan and GSK Global not limited to clinical safety and pharmacovigilance division in Japan

職務内容および勤務地の変更範囲は会社の定めるところとする。

必要な条件Basic Qualification スキル Skill 臨床医としての能力。医学的知識、患者視点の理解、患者ケア管理の経験、患者安全の課題に関するリスク・ベネフィット評価の適切な判断、日本のヘルスケア環境での勤務経験を含む Physician's competency, including medical knowledge, understanding patient perspectives, experience in managing patient care, having sound judgement in benefit/risk evaluation on patient safety issues, and working in the Japanese healthcare environment 専門性と科学的責任に基づき、独立した臨床評価や意思決定を行う能力 Ability to make independent clinical assessments and decisions, based on professional and scientific responsibilities 誠実さと強い倫理感 Integrity and strong feeling for ethics 強いチームワーク指向 strong team spirit 自己啓発力と新たなテクノロジへの興味 Capable of self-development and curiosity about new technology レジリエンス Resilience 経験 Experience 医師として5年以上の臨床経験があること Having 5 or more years of clinical experience as a physician. 学位/資格/語学力 Education/certification/Language 日本の医師免許 Medical degree in Japan ネイティブレベルの日本語力/ビジネスレベルの英語力 Writes and Speaks fluent Japanese at native level / Business level English in reading/ writing/ speaking

日本での就労資格を有すること。

望ましい条件 Preferred Qualification スキル Skill モチベーション管理能力、ゴール指向 Self motivated, flexible and goal oriented 科学的データの迅速な把握と理解・解釈し、利活用する力 Grasps scientific data quickly, understands its interpretation and implications and drives to results based on its use すべてのレベルでコミュニケーションを取りながら、包括的なチームプレーヤーになる能力 Ability to be an inclusive team player, communicating at all levels リーダーシップ Leadership 疫学と公衆衛生の専門知識、大規模データの分析力 Preferred expertise in epidemiology and public health, ability to analyze large datasets 経験 Experience 最低3-5年の製薬業界、特にPVでの勤務経験 Minimum 3-5 years of industry experience, especially in a PV function, with leadership experience. 筆頭者としての学会発表と論文作成経験 Experience presenting at academic conferences and publishing scientific papers as lead author 治験や臨床試験への参加経験 participated in a pre-approval clinical trial or a clinical study 学位/資格/語学力 Education/certification/Language 自身の専門領域での専門医資格、または、博士号 Having a specialist qualification in your area of expertise or a doctorate Skills Digital Fluency, Enterprise Leadership, Influencing Without Authority, Pharmacovigilance, Presentation Techniques 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...