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Pharmacovigilance Reporting Associate

1-3 years
Not Disclosed
10 July 18, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Pharmacovigilance Reporting Associate – ICON, Tokyo

Job Summary

ICON plc, a global leader in clinical research and healthcare intelligence, is hiring a Pharmacovigilance Reporting Associate in Tokyo, Japan. This role involves preparing and reviewing safety reports, managing adverse event data, and ensuring regulatory compliance for both clinical and post-marketing surveillance. Ideal for candidates with a background in pharmacovigilance, drug safety, or regulatory affairs, this position is critical for ensuring global drug safety and supporting patient well-being.


Key Responsibilities

  • Prepare and review Individual Case Safety Reports (ICSRs) and Periodic Safety Update Reports (PSURs) with accuracy and regulatory compliance

  • Analyze and compile adverse event data from clinical trials and post-marketing sources

  • Collaborate cross-functionally with regulatory, clinical, and data management teams

  • Ensure timely submission of safety reports to regulatory authorities and sponsors

  • Stay current with GVP, ICH guidelines, and international regulatory requirements


Required Skills & Qualifications

  • Bachelor’s degree in Life Sciences, Pharmacy, or related discipline

  • Experience in pharmacovigilance or drug safety, ideally in a regulated environment

  • Strong understanding of safety reporting processes and regulatory frameworks

  • Detail-oriented with strong organizational and analytical skills

  • Effective communicator and team player within cross-functional teams

  • Familiarity with PV software tools and pharmacovigilance databases a plus


Perks & Benefits

  • Competitive salary (not specified in the listing)

  • Generous annual leave entitlements

  • Multiple health insurance options for individuals and families

  • Global Employee Assistance Program access (LifeWorks)

  • Comprehensive retirement planning options

  • Life assurance coverage

  • Optional country-specific benefits: childcare vouchers, gym memberships, travel passes, and more

  • Strong diversity, inclusion, and career development culture


Company Description

ICON plc is a world-leading provider of drug development and healthcare intelligence services. With operations in over 40 countries, ICON supports pharmaceutical, biotechnology, and medical device companies in delivering safe and effective therapies worldwide.


Work Mode

Hybrid / Home or Office-based – Tokyo, Japan


Call-to-Action

Ready to shape the future of drug safety and regulatory compliance? Apply now to join ICON's pharmacovigilance team in Tokyo and be part of a global leader in clinical research.