Job Description

Pharmacovigilance（PV／安全性）業務は、GSK製品を使用する患者さんの安全を守る重要な仕事であり、日本だけでなく世界各国で厳しい法規制が設けられています。我々安全性部門の業務は、これら法規制を守りながら、GSK製品の安全性情報を収集、評価し、適切な対策を実施することです。

このポジションでは、以下のような業務を実施します。昨今は、Automationの技術を取り入れる等、最適なプロセスの構築や効率化を図ることも重要な業務の一つです。

• 安全性情報（個別症例）を適切に収集・評価するための仕組み作りと管理：
  • 日本の法規制の遵守だけでなく、GSK Globalともアラインした収集手順、データベース入力手順の構築
  • 各種ステークホルダー（社内、提携会社、委託ベンター等）への安全性に関するトレーニング
  • 規制当局及び提携会社への安全性情報の報告
  • 上記の遵守状況のOversight
• 個別症例業務を効率的に行えるように、症例業務を包括的理解し、GSK Globalとも協働し、　Automationの技術を取り入れる等、最適なプロセスの構築・改善に取り組む。
• 主に個別症例業務に関して、規制当局の査察やGlobal／提携会社のAudit対応を行う。

Pharmacovigilance (PV/Safety) activities play a crucial role in protecting the safety of patients using GSK products. Strict regulations have been established not only in Japan but also across the globe. Our safety department is responsible for collecting and evaluating safety information on GSK products in compliance with these regulations and implementing appropriate measures.

In this position, you will perform the following duties. Recently, one of the key tasks has been to build optimal processes and improve efficiency by incorporating automation technologies, among other initiatives.

• Establish and manage mechanisms for appropriately collecting and evaluating safety information (ICSRs):
  • Develop collection procedures and database entry protocols that not only comply with Japanese regulations but also align with GSK Global.
  • Provide safety-related training to various stakeholders (internal teams, license companies, vendors, etc.).
  • Report safety information to regulatory authorities or Licensing partners.
  • Oversee compliance with the above processes.
• Efficiently manage individual case processing:
• Comprehensively understand case operations, collaborate with GSK Global, and work on building and improving optimal processes by integrating automation technologies.

• Handle inspections and audits:
• Manage inspections by regulatory authorities and address audits by Global/Partner companies, primarily in relation to individual case processing.

※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

• PV関連（GVP,GCP,GPSP）の法規制の十分な理解
• PV業務、個別症例の管理に関する十分な知識
• 国内外のステークホルダーと協働するスキル、コミュニケーションスキル
• 業務改善能力（改善意識を持ち、課題を設定、論理的に考え、解決できる）
• 自己管理能力（マルチタスクの管理、スケジュール管理ができる）
• 新しい知識を積極的に学ぶ姿勢

• Sufficient understanding of PV-related regulations (GVP, GCP, GPSP).
• Adequate knowledge of PV activities and management of individual case reports.
• Ability to collaborate with both domestic and international stakeholders, along with strong communication skills.
• Business improvement capability (possessing a mindset for continuous improvement, the ability to identify challenges, think logically, and solve problems).
• Self-management skills (ability to manage multiple tasks and handle scheduling effectively).
• A proactive attitude toward acquiring new knowledge.

経験 Experience

• 医薬品のPV領域での業務経験（5年以上）
• 個別症例業務に携わった経験（3年以上）
• 市販後個別症例業務（市販後臨床試験・臨床研究由来の症例含む）経験

• A minimum of 5 years of work experience in the pharmacovigilance (PV) field of pharmaceuticals.
• At least 3 years of experience in handling individual case report activities.
• Experience in Post-Marketing Individual Case Management (Including Cases Derived from Post-Marketing Clinical Trials and Clinical Research)

学位/資格/語学力 Education/certification/Language

• ライフサイエンス系学位　学士以上
• 英語力（読み書きは必須。海外担当者とTCで口頭コミュニケーションできるレベル）
• 日本語力：Fluent level（日本語で書かれた契約書や手順書を読み書きできるレベル）

• Bachelor's degree or higher in a life science-related field.
• Proficiency in English (reading and writing are mandatory; capable of verbal communication with overseas colleagues via teleconference).
• Fluent Japanese level

望ましい条件 Preferred Qualification

スキル Skills

• チームリード能力
• 交渉力

• Team leadership ability
• Negotiation skills

経験 Experience

• Argusでの症例業務経験
• 治験個別症例業務経験
• 規制当局の査察やGlobal／提携会社のAudit経験
• Pharmacovigilance業務へのAutomation（AI, RPA等）の導入経験
• Globalとのプロジェクトでの協働経験、プロジェクトリード経験

• Experience in case processing using Argus.
• Experience in Clinical Trial Individual Case Management
• Experience with inspections by regulatory authorities and audits by Global/partner companies.
• Experience in introducing automation (AI, RPA, etc.) into pharmacovigilance operations.
• Experience in collaborating on projects with Global teams, including project leadership.

学位/資格/語学力 Education/certification/Language

• 薬剤師、もしくは薬学部の学位
• 英語力（海外担当者と流暢にコミュニケーションできるレベル、業務に関する報告書を英語で執筆できるレベル）
• 日本語力：Fluent level（日本語で書かれた契約書や手順書を読み書きできるレベル）

• Pharmacist license or a degree in pharmacy.
• Proficiency in English (fluent communication with overseas counterparts and capable of drafting work-related reports in English).
• Fluent Japanese level( A level enabling to read and write contracts and manuals written in Japanese)

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.

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