Associate II, Patient Safety Solutions

7 days ago

Toronto, Ontario, Canada Fortrea Full time

The Associate II, Patient Safety Solutions will manage adverse event reporting and ensure compliance with regulatory timelines.

Key Responsibilities

  • Process and review adverse event reports from clinical trials and post-marketing sources.
  • Enter safety data, write patient narratives, and code events using MedDRA.
  • Ensure timely submission of expedited safety reports to regulatory authorities and clients.
  • Maintain tracking systems, project documentation, and support audits and inspections.
  • Collaborate with clients and mentor team members as needed.

What You Need To Bring

  • Degree in Life Sciences or related field preferred.
  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
  • 2+ years of pharmacovigilance or safety experience
  • Strong attention to detail, communication skills, and ability to work independently
  • Proficiency in MS Office and safety databases

Note:
This role does
not provide sponsorship
.

Work Environment

  • Work is performed in an office environment with exposure to electrical office equipment.
  • Occasional drives to site locations with occasional travel both domestic and international.

Physical Requirements

  • Frequently stationery for 6-8 hours per day.
  • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
  • Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
  • Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
  • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
  • Regular and consistent attendance.
  • Varied hours may be required.

Learn more about our EEO & Accommodations request here.

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