PV Associate

Summary

Join PrimeVigilance, a specialized pharmacovigilance service provider, as an ICSR Management Specialist and contribute to achieving company goals while providing excellent support to clients.

Requirements

• Degree educated in a Life Sciences subject
• Ambition to work within Pharmacovigilance
• Fluency in English and Japanese
• Good IT skills (MS Office)
• Excellent organization skills with attention to detail
• Excellent interpersonal and communication skills

Responsibilities

• Assures and exerts activities leading to effective cooperation with clients in the area of ICSR Management
• Contributes to achieving company's goals and objectives
• Works under supervision of more experienced colleague
• Providing support to other activities undertaken by the project team on behalf of the client and the company
• Performing activities in the scope of ICSR management unit within agreed extent and timeframe (including, but not limited to): Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines
• Performing ICSR follow up
• SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review)
• Reconciliation (clinical, partners)
• Product Quality Complaint handling and interaction with Quality Assurance
• Medical Information interaction
• Database Outputs and Reports (including data for monthly reporting to clients)