Drug Safety Associate - Tokyo Osaka - Office Hybrid
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
As a Drug Safety Associate at ICON, you will ensure the safety of investigational drugs and contribute to the advancement of innovative treatments and therapies.
What You Will Do:
Your role will involve delivering pharmacovigilance and drug safety work to a high standard, working closely with your team and stakeholders.
Key responsibilities include:
- 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 the development and maintenance of safety databases and tracking systems.
- Collaborate with cross-functional teams to ensure timely and accurate reporting of safety data.
Your Profile:
You will bring relevant pharmacovigilance and drug safety experience, along with the following qualifications and skills.
Required qualifications and experience:
- Bachelor's degree in a scientific or healthcare-related field.
- 1-2 years of experience in pharmacovigilance or drug safety within the pharmaceutical or biotechnology industry preferred.
- Knowledge of pharmacovigilance regulations and guidelines (e.g., ICH, FDA, EMA).
- Strong attention to detail and ability to work effectively in a fast-paced environment.
- Excellent communication and organizational skills, with the ability to collaborate across teams and prioritize tasks efficiently.
- Willingness to travel as required (approximately 10%)
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
