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.
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