Safety/PV Specialist

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Job details

Company overview

Leading global CRO company
We provide drug discovery, development, lifecycle management and laboratory services.We are a company that provides services related to drug development. We are responsible for the collection and analysis of clinical trial data for pharmaceutical products, support for regulatory filings, and quality control. Our team of experts provides tailored solutions to ensure the safety and efficacy of our clients' needs. We are focused on providing high quality services in compliance with strict regulations. We provide professional support with our experience and knowledge to help our clients succeed in drug development.

Responsibilities

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

Requirements

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

Salary

5 - 8 million yen

Location

Tokyo