Drug Safety Associate (Pharmacovigilance)

About the role

ICON is a global healthcare intelligence and clinical research organisation. As a Drug Safety Associate in Tokyo, you will ensure the safety of investigational drugs and help advance new treatments and therapies. The role delivers pharmacovigilance and drug safety work to a high standard, working closely with the team and stakeholders, in a hybrid office setting.

Key responsibilities

• Collect and review adverse event reports from clinical trials and post-marketing sources.
• Conduct initial assessment and coding of adverse events according to established procedures and regulatory guidelines.
• Prepare and submit expedited safety reports to regulatory authorities and investigators as required.
• Assist in developing and maintaining safety databases and tracking systems.
• Collaborate with cross-functional teams to ensure timely and accurate reporting of safety data.

Required profile

• Bachelor's degree in a scientific or healthcare-related field.
• 1-2 years of experience in pharmacovigilance or drug safety in the pharmaceutical or biotechnology industry preferred.
• Willingness to travel approximately 10% of the time.
• Legal right to work in the country where the role is based.

Required skills

• Knowledge of pharmacovigilance regulations and guidelines (e.g. ICH, FDA, EMA).
• Strong attention to detail and ability to work in a fast-paced environment.
• Excellent communication and organisational skills, able to collaborate across teams and prioritise tasks.

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.