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.