ICSR Management Administration Staff

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

PharmacovigilancePV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GVPGCPGPSP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GVPGCP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 / Bachelors 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 / Bachelors 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.

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