Pharmacovigilance Associate Hybrid

Pharmacovigilance Associate, Markham (Hybrid)

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Position Type: Full Time

Department: QA & PV

Work Location: Markham, ON

Work Arrangement: Hybrid – in office 2–3 days a week required

Work Hours: Standard Business Hours Monday to Friday

Travel Required: No

A proudly Canadian company, Sentrex Health Solutions is a fully integrated specialty distributor and patient support provider for pharmaceutical manufacturers, physicians, and their patients. We provide innovative solutions focused on ensuring patients have access and the support they need to maximize their treatment outcomes. We do this through strategic distribution models and patient support programs that are backed by powerful, integrated technology, a dedicated in‑house creative agency, and experienced, cross‑functional teams.

Our core capabilities include Specialty Pharmacy Services, Customized Solutions for Warehouse, Wholesale & Distribution, Patient Support Programs, Strategic Creative Services as well as HCP & Clinic Services.

• 100% Canadian with locations across the country
• State‑of‑the‑art facilities to provide high‑quality products and services
• Opportunity to be part of a winning, high‑performing team
• Collaborative, engaging workplace culture – we are passionate about our people!
• Flexible working environment that promotes a healthy work‑life balance
• Diverse and inclusive culture where your talent and commitment to excellence are welcomed and valued
• High‑growth environment that provides opportunities for learning and growth supported by our Employee Development Program and industry‑leading, in‑house corporate training offered throughout the year
• Quarterly virtual social events

The Pharmacovigilance (PV) Associate is a role based in our facility in Markham and the key functions include managing the collection, processing, and reporting of Adverse Events (AEs) and Product Complaints in compliance with all organization and national pharmacovigilance requirements. The PV Associate will also be responsible for helping out with administrative aspects of the Quality Management System (QMS) to help drive compliance with GxP regulations through the QMS.

• Managing the collection, processing, and reporting of adverse events (AEs).
• Adhering to and contributing to the structure and objective of compliance across the organization.
• Ensuring the organization, accuracy, and completeness of pharmacovigilance information for a variety of manufacturers and patient assistance programs, including audit preparation and management of the Pharmacovigilance inbox.
• Maintaining high compliance standards in regard to reporting timelines, quality of reporting, and assisting with responding to and tracking queries from stakeholders and manufacturers.
• Collecting and recording data related to AE cases. Accountable for recognizing, triaging, and reporting as per the program or manufacturer requirements.
• Reporting and submitting reportable AEs to manufacturers as per Health Canada regulations and client guidelines.
• Electronic filing and archiving of PV documents to maintain audit readiness at all times.
• Creating and reviewing Standard Operating Procedures (SOPs) and Work Instructions (WIs) as needed.
• Conducting Pharmacovigilance trainings as needed.
• Conducting period case reconciliation with applicable departments and clients as needed.
• Collaborating with the internal SHS teams to find process efficiencies.
• Helping with administering the Quality Management System.
• 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 with the ability to work in various databases.
• Exceptional organizational skills and strong attention to detail.
• Demonstr…