Safety/PV Specialist

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募集要項

会社概要

同社は医薬品の開発過程を支援する各種の受託事業をおこなう日系企業です。医薬品の臨床試験データの収集・分析、薬事申請の支援、品質管理などの業務を担当しています。専門家チームがお客様のニーズに合わせたソリューションを提供し、安全性と有効性の確保に努めています。同社は、厳格な規制に準拠し、高品質なサービスを提供することに注力しています。お客様の医薬品開発の成功をサポートするために、経験と知識を活かしたプロフェッショナルなサポートを提供しています。

業務内容

Main responsibilities:

• Mainly safety information work for global clinical trials
• Safety information management work for investigational drugs and over-the-counter drugs
  • Evaluation of safety information (global and local cases)
  • Input of safety information, preparation of agency reports (draft)
  • Preparation of PV-related documents
• Client support

応募条件

Minimum requirements:

• ~3 years of experience in the PV department (regardless of the work content)
• If you have a lot of knowledge/experience in PV work, experience only in CRO is acceptable
• Receiving, triage, inputting, QC, side effect reports to the Ministry of Health, Labor and Welfare (PMDA) and other safety information (side effect information) for domestic and foreign pharmaceuticals (clinical trial products and commercially available products) etc.
• A person who has a deep understanding of the flow of PV work and can carry out the work independently without detailed instructions
• ~ 2 years experience in inputting data into databases such as Argus and Aris
• Basic skills in Word, Excel and Outlook

Preferred qualifications:

• Those with experience in paramedical fields such as pharmacists and nurses
• Experience in reporting defects in medical devices
• Experience in revising package inserts
• Experience in research reports from literature reviews, measures reports on overseas measures, and　accumulation reports (regular market reports, regular clinical trial reports)
• Experience in regenerative medicine and regular reporting of infectious diseases

給与

500 - 800 万円

勤務地

東京