About the role

Pharmacovigilance Associate managing adverse-event reporting and quality systems for Canadian pharmaceutical manufacturers and patient-support programs. Ensuring Health Canada compliance and audit readiness.

Responsibilities

Manage the collection, processing, and reporting of adverse events and product complaints
Adhere to and contribute to compliance objectives across the organization
Ensure organization, accuracy, and completeness of pharmacovigilance information
Prepare for audits and manage the Pharmacovigilance inbox
Maintain compliance with reporting timelines and reporting quality
Respond to and track queries from stakeholders and manufacturers
Collect and record data related to adverse event cases
Recognize, triage, and report cases according to program or manufacturer requirements
Submit reportable adverse events to manufacturers according to Health Canada regulations and client guidelines
Electronically file and archive PV documents to maintain audit readiness
Create and review Standard Operating Procedures and Work Instructions
Conduct pharmacovigilance training as needed
Conduct periodic case reconciliation with applicable departments and clients
Collaborate with internal teams to identify process efficiencies
Assist with administration of Quality Management Systems
Perform other tasks as required

Bilingualism (English and French) is an asset
3+ years of experience in Pharmacovigilance or relevant industry experience
3+ years of experience in the Pharma environment familiar with Health Canada rules and regulations relating to GxP processes
Good understanding of Health Canada GVP regulations
Proficient in the Microsoft Suite of products
Ability to work in various databases
Exceptional organizational skills and strong attention to detail
Demonstrated prioritization skills and ability to multi-task to meet tight deadlines
Proven analytical and problem-solving skills
Above average verbal and written communication skills
Ability to work as part of a team and collaborate with cross-functional partners
Experience with QMS is an asset

State-of-the-art facilities to provide high-quality products and services
Flexible working environment that promotes a healthy work-life balance
Diverse and inclusive culture
Employee Development Program
Industry-leading, in-house corporate training offered throughout the year
Quarterly virtual social events
Competitive salary
Generous vacation entitlement
Wellness Program (5 paid days off for your well-being!)
Paid Sick Days
Competitive Benefits Package including Dental & Extended Health Benefits, AD&D, LTD & Employee/Dependent Life Insurance
Employee & Family Assistance Program
RRSP Matching Program