安全性情報部は、GSK Japanが販売している製品の副作用等の安全性情報を適切に入手できるよう対処し、入手した情報を管理している部署です。
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。
また、AIや自動化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会社として重要な取り組みとしているため、これらを前向きに業務に取り入れて運用出来る姿勢のある方を求めています。
このポジションでは、以下のような業務を実施します。
・安全性(主にGVP、GCP、GPSP)の規制を遵守するために発生する管理業務(安全性データベース使用含む)
・ 安全性個別症例対応(Case processing)のサポート
・ 安全性に係る契約書、手順書等の記録・保管業務
具体的には、安全性個別症例の翻訳対応、社内外とのリコンシリエーション(照合)対応、定期的なデータベースからのデータ抽出・加工や案の作成、社内(国内外)への定期的なメール報告等になります。
必要な条件Basic Qualification
スキル Skill
Microsoft Office Skill 全般(Word, Excel, PowerPoint, Outlook, OneDrive, OneNote Share Point等) / General Microsoft Office skills.
安全性の規制(主にGVP、GCP)に関する基礎的な知識もしくは安全性関連文書の取り扱い経験 / Basic knowledge of safety regulations (mainly GVP, GCP) or experience handling safety-related documents.
データベースへの入力、データ抽出等の補助経験 / Assistant experience with database entry, data extraction, etc.
英文資料の取り扱い経験 / Experience handling English documents.
経験 Experience
ライフサイエンス系領域での業務経験 / Work experience in the life sciences field.
Excel機能等を使用したデータ作成や加工経験
学位/資格/語学力 Education/certification/Language
学士以上 / Bachelor's degree or higher.
英語力(海外担当者とメールでコミュニケーションが出来るレベルであればなお望ましい) / English proficiency (ability to communicate via email with overseas counterparts is preferred).
望ましい条件 Preferred Qualification
スキル Skills
メール、電話でのコミュニケーション / communication by email and phone.
経験 Experience
医薬品のPV領域での業務経験 / Work experience in the pharmaceutical PV area.
安全性の個別症例業務に携わった経験 / Experience involved in individual case safety report (ICSR) processing.
学位/資格/語学力 Education/certification/Language
ライフサイエンス系学位 学士以上であればなお望ましい / Bachelor's degree or higher in a life science field is highly desirable.
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.
We are committed to creating an inclusive workplace and providing equal opportunities for all applicants. We embrace an agile working culture across our roles, so if flexibility is important to you please discuss opportunities with our hiring team. If you need any adjustments to the recruitment process to help you demonstrate your strengths and capabilities, contact Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.
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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