Drug Safety Associate - AE Intake & Follow Up - Client Dedicated - Toronto, Canada

We are seeking a detail-oriented Drug Safety Associate – AE Intake & Follow Up to support end-to-end pharmacovigilance activities for our clients. In 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.