Safety Science Specialist Client Dedicated Toronto, Canada

Fortrea


Job Location:

Toronto - Canada

Monthly Salary: Not Disclosed
Posted on: 30+ days ago
Vacancies: 1 Vacancy

Job Summary

We are seeking a detail-oriented Safety Science Specialist to support end-to-end pharmacovigilance activities for our this role you will manage adverse event (AE) reporting across clinical trials and post-market programs ensuring timely accurate and compliant delivery in line with regulatory requirements and client expectations.

Key Responsibilities:

  • Process and review adverse event (AE/SAE) reports from clinical and post-marketing sources

  • Enter and maintain safety data in applicable databases and tracking systems

  • Assess cases for completeness accuracy and regulatory reporting requirements

  • Prepare patient narratives and code events using MedDRA

  • Support expedited reporting to clients and regulatory authorities within required timelines

  • Identify missing information and coordinate follow-up as needed

  • Contribute to safety reporting (e.g. expedited and periodic reports) and reconciliation activities

  • Perform quality checks and support continuous improvement initiatives

  • Collaborate with internal teams and clients to ensure high-quality service delivery

  • Maintain compliance with SOPs regulatory standards and health & safety requirements

What you need to bring:

  • Degree in Life Sciences Pharmacy Nursing or related field (or equivalent experience)

  • 1 year of pharmacovigilance/safety experience or relevant experience in pharma biotech or CRO

  • Strong attention to detail and organizational skills

  • Effective communication and ability to work both independently and in a team

  • Proficiency in MS Office; experience with safety databases is an asset

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.


Required Experience:

IC

We are seeking a detail-oriented Safety Science Specialist to support end-to-end pharmacovigilance activities for our this role you will manage adverse event (AE) reporting across clinical trials and post-market programs ensuring timely accurate and compliant delivery in line with regulatory requir...

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