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.
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.