Drug Safety Associate
ICON · Tokyo, Japan +1 more
The apply link worked recently (not employer-confirmed).
Role summary
This Drug Safety Associate position involves collecting and assessing adverse event reports from clinical trials and post-market sources, coding safety data according to regulatory standards, and preparing expedited reports for authorities. The role requires a bachelor's degree in a scientific field and 1–2 years of pharmacovigilance experience, with strong knowledge of regulatory guidelines and attention to detail. The position is based in Tokyo or Osaka and operates on a hybrid schedule.
What they're looking for
- Bachelor's degree in scientific or healthcare-related field
- 1-2 years of pharmacovigilance or drug safety experience in pharmaceutical/biotechnology industry
- Knowledge of pharmacovigilance regulations and guidelines (ICH, FDA, EMA)
- Strong attention to detail and ability to work in fast-paced environment
- Excellent communication and organizational skills with cross-team collaboration ability
- Willingness to travel approximately 10% as required
What you'll be doing
- Collect and review adverse event reports from clinical trials and post-marketing sources
- Conduct initial assessment and coding of adverse events per established procedures and regulatory guidelines
- Prepare and submit expedited safety reports to regulatory authorities and investigators
- Assist in development and maintenance of safety databases and tracking systems
- Collaborate with cross-functional teams on timely and accurate safety data reporting
Privacy & handoff
This role links to ICON's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.