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

Toronto, CanadaOn-site

Responsibilities

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,
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 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 .
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
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.

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
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.
Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
Learn more about our EEO & Accommodations request here .