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Principal Drug Safety Associate

ICON
Tokyo, Japan; Osaka, Japan
Hybrid

About this role

Principal Drug Safety Associate

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 Principal Drug Safety Associate at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.

What You Will Do:

Your focus will be on coordinating pharmacovigilance and drug safety delivery, resolving issues, and developing team capability.

Key responsibilities include:

  • Overseeing the safety aspects of clinical trials, including the review and deep-dive of adverse event reports.
  • Partnering with cross-functional teams to ensure compliance with regulatory requirements and company standards.
  • Providing expert guidance on drug safety issues, including risk management strategies and safety signal detection.
  • Contributing to the development and implementation of pharmacovigilance processes and procedures.
  • Mentoring and training junior team members on drug safety practices and regulations.

Your Profile:

You will have solid pharmacovigilance and drug safety experience, with the ability to manage competing priorities and develop your team.

Required qualifications and experience:

  • Bachelor's degree in a relevant scientific discipline or healthcare-related field
  • Minimum of 5 years of experience in drug safety/pharmacovigilance within the pharmaceutical or biotech industry.
  • Strong understanding of global regulatory requirements related to drug safety, including ICH guidelines and FDA regulations.
  • Excellent analytical skills with the ability to interpret complex medical data.
  • Effective communication skills, with the ability to collaborate across diverse teams.

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.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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