PMSやPharmacovigilance(PV/安全性)は、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。我々の業務は、これら法規制を守りながら、自社製品の市販後の有効性や安全性の情報を収集、評価し、適切な対策を実施することです。また、昨今、様々な会社と提携したり、これまでとは異なるデータやAIなども活用してビジネスを行う必要性も増しており、このような環境変化にも対応しながら、上記の業務を適切に実施する必要があります。
このポジションでは、以下のようなPMS/PVに係る幅広い業務を実施します。法令遵守だけでなく、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。
- GPSP関連業務(製造販売後調査(CRO)等の管理、立案、対応、PMSの進捗管理等)
- HRD(HIV-related drugs)共同調査の運営管理
- PMS結果の公表(論文・学会報告等)
- 市販薬に関連する安全性情報の評価・検討
- 市販薬に対する安全対策(医療従事者・患者への情報提供等)の立案
- 電子添文改訂業務、情報提供業務
- 市販直後調査関連業務
- Third Partyとの契約、自己点検、教育、手順書関連業務
- 安全性定期報告、未知非重篤副作用定期報告対応
- RMP(リスクマネジメントプラン)の策定・改訂及び実施
- 再審査申請及び適合性調査対応
- 規制当局の査察やGlobal/提携会社のAudit対応
※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
PMS/PV関連の法規制の理解
コミュニケーション能力・対人関係対応能力:社内外の様々なStakeholderと協調性を持って協業ができる方
リーダーシップ能力:変革を推進できるリーダーシップ
複数の業務を同時に管理するためのtime management能力、マルチタスクに長けている方
アジリティー:変化する環境に合わせ柔軟に適応、対応することができる
革新的な問題分析及び問題解決能力
クロスファンクショナルな活動を通じて会社に貢献し、成長する意欲
様々なシステムへの対応能力(Veeva Vault, Gateway等)
経験 Experience
薬機法、GVPに関する業務経験
学位/資格/語学力
Education/certification/
Language
大卒(理系)
または安全性の経験あれば理系以外も可
英語力(TOEIC 730点程度)読み、書き、スピーキング
市販後の安全対策/PMSに興味をもち、熱意をもって安全対策を推進できる方
望ましい条件 Preferred Qualification
経験 Experience
GPSP、電子添文に関する業務経験
Why Us?
At ViiV Healthcare, we will not rest until we leave no person living with HIV behind. Until the 40 million people living with HIV is down to zero, we will continue searching for new ways to limit the impact of HIV.
We are the only pharmaceutical company solely focused on combating, preventing, and ultimately eradicating HIV and AIDS. At ViiV Healthcare, we do things differently. Born out of a partnership between GSK and Pfizer in 2009, with Shionogi joining in 2012, we are determined to help end the HIV epidemic. We are guided by our mission to leave no person living with HIV behind and it is this mission that unites our employees located across the globe. We combine expertise in research, manufacturing, policy and more to push the boundaries of what people think is possible in HIV treatment and care. As a result of our connection with GSK, we are able to draw on their proud history and resources. This means that you would receive all the employee benefits offered by GSK.
Living our mission of leaving no person living with HIV behind means keeping inclusion and diversity at the heart of everything we do - from our breakthrough innovation, to our diverse portfolio of medicines as well as the work we do to partner with HIV communities. Having a truly inclusive culture where we're all able to be ourselves and feel like we belong will make us an even stronger team, better able to perform as a business and deliver on our mission to leave no person living with HIV behind.
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
ViiV 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 ViiV's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to ViiV. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and ViiV. 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 ViiV. ViiV 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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Tokyo GSK Full timeJob summary: The Safety Control Associate is responsible for ensuring compliance with regulatory requirements in Japan. They will coordinate safety control activities such as pharmacovigilance (PV) monitoring, risk management planning (RMP), and third-party audits. Key skills inc ...
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Minato GSK Full time￥9,000,000 - ￥12,000,000 per yearPMSやPharmacovigilance(PV/安全性)は、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。我々の業務は、これら法規制を守りながら、自社製品の市販後の有効性や安全性の情報を収集、評価し、適切な対策を実施することです。また、昨今、様々な会社と提携したり、これまでとは異なるデータやAIなども活用してビジネスを行う必要性も増しており、このような環境変化にも対応しながら、上記の業務を適切に実施する必要があります。 · ...
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Japan - Tokyo - Akasaka GSKPMSやPharmacovigilance(PV/安全性)は、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。 · Company-provided training and development opportunitiesCompetitive salary and benefits packageAchievement-based bonus structure ...
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Tokyo GSK Full timePMS and pharmacovigilance are important jobs to protect patients' safety in Japan and around the world. Our business is to collect, evaluate, and implement appropriate measures for post-marketing information on our products while following laws. · ...
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Akasaka, Tokyo GSKThe Site Safety Control Scientist will perform various duties related to Pharmacovigilance (PV) in Japan. · ...
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Tokyo GSK Full timePMS (Pharmacovigilance) is an important function that ensures patient safety worldwide under strict regulations. · ...
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Japan - Tokyo - Akasaka GSKPMS and pharmacovigilance are important jobs that protect patient safety not only in Japan but also around the world. Our business is to collect and evaluate information on the effectiveness and safety of our products after they go on sale while complying with laws and regulation ...
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