ViiV Safety Control Scientist
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Job Location:
Monthly Salary:
Posted on:
15 hours ago
Vacancies:
1 Vacancy
Job Summary
PMSやPharmacovigilancePV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
HRDHIV-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 atruly inclusive culture where were 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
ViiVdoes 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 ViiVs 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 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 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.
Required Experience:
IC
Key Skills
- Laboratory Experience
- Immunoassays
- Machine Learning
- Biochemistry
- Assays
- Research Experience
- Spectroscopy
- Research & Development
- cGMP
- Cell Culture
- Molecular Biology
- Data Analysis Skills
About Company
About us We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have 3 global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.
