Role & Responsibilities
• Process and review Individual Case Safety Reports (ICSRs) from multiple sources including literature, affiliates, and health authorities
• Perform case triage, data entry, MedDRA coding, causality, seriousness, and expectedness assessment
• Prepare medically accurate case narratives and perform quality checks
• Manage follow-ups, reconciliation, and compliance tracking for safety reporting
• Support expedited and periodic safety report submissions to regulatory authorities
• Maintain regulatory databases and support product lifecycle management activities
• Perform literature searches and maintain validated search strategies
• Support audits, inspections, and compliance documentation
• Collaborate with global PV teams and mentor junior team members
Qualifications
• Degree in Life Sciences / Health / Biomedical Sciences
• Medicine, Dentistry, Nursing, Physiotherapy background is an added advantage
• JLPT N2 or above (Japanese language proficiency)
Experience
• Prior experience in Pharmacovigilance / Drug Safety preferred
• Experience with PMDA safety reporting and Japanese PV operations preferred
Skills
• Pharmacovigilance operations and ICSR processing
• MedDRA coding and safety database handling
• Japanese (JLPT N2+) and English communication
• Regulatory compliance (ICH, EMA, PMDA, global PV regulations)
• Literature review and safety data analysis
• Quality control and audit readiness
• MS Office and safety database proficiency
• Analytical, documentation, and time management skills
About the Company
• Parexel is a global clinical research organization delivering clinical trials, regulatory, consulting, and market access services to advance life-changing therapies worldwide
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