Pharmacovigilance Reporting Associate

About the role

ICON is a global healthcare intelligence and clinical research organisation. As a Pharmacovigilance Reporting Associate in Tokyo (also listed as Tokyo Osaka), you will prepare safety reports accurately and on time for clinical trials and post-marketing activities. The role is office hybrid and remote.

Key responsibilities

• Prepare and review safety reports, including periodic safety updates and individual case safety reports, ensuring accuracy and compliance with regulatory standards.
• Collect and analyse adverse event data from clinical trials and post-marketing sources to support comprehensive safety reports.
• Maintain up-to-date knowledge of regulatory requirements and industry best practices for pharmacovigilance reporting.
• Collaborate with clinical, regulatory and data management teams to gather information and resolve reporting issues.
• Ensure safety reports are submitted on time to regulatory authorities and sponsors.

Required profile

• Bachelor's degree in life sciences, pharmacy or a related field.
• Experience in pharmacovigilance or drug safety, with a strong understanding of safety reporting processes and regulatory requirements.
• Willingness to travel approximately 10% of the time.
• Legal right to work in the country where the role is based.

Required skills

• Attention to detail and organisational skills, able to prepare and review complex safety reports accurately.
• Strong communication and collaboration skills in a multidisciplinary team.
• Ability to manage multiple tasks and prioritise in a fast-paced, regulated environment.

What we offer

• Competitive base salary and performance-related incentives.
• Health and wellbeing programmes, including medical, dental and vision coverage where applicable.
• Retirement and pension plans, life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.