Specialist, Pharmacovigilence

Location:

1685 Tech Ave, Mississauga, Ontario, L4W 0A7

At Shoppers Drug Mart, we’re innovating health and wellness in Canada. From prescriptions to walk‑in clinics, and a beloved loyalty program, we’re caring and supporting our customers in new ways every day.
With more than 1,300 locally owned and operated stores from coast to coast, the Shoppers Drug Mart network is more than a great place to shop, it’s a great place to work. We’re committed to building our talented team who champion collaboration, kindness and inclusivity. Join our team, and help recognize a healthy future for your career and for all Canadians.

The Pharmacovigilance Specialist is responsible for facilitating questions and providing guidance to our Pharmacovigilance team while playing an active role on the team reconciling cases, QC checks, and supports with audits, inspections, contracts, and agreements.

The Pharmacovigilance Specialist will be the key liaison between patient‑facing staff, internal departments, and the pharmaceutical companies regarding safety data. The Pharmacovigilance Specialist will develop and maintain tracking and trending reports for the pharmacovigilance department.

• Comply with Good Documentation Practices by ensuring the consistency and accuracy of all patient records as well as all other documents
• Perform and document reconciliation reports.
• Perform and document routine QC Checks
• Support or lead investigations of Deviation Reports for late case reporting and other noncompliant activities related to PSPs
• Help develop and implement CAPAs to ensure compliance with program requirements
• Review and update Standard Operating Procedures, Work Instructions and Reference Documents as required
• Deliver program specific AE/PV training to new members of the team (PCSs, Reimbursement, Case Managers)
• Support the Manager, Pharmacovigilance with assigned tasks
• Act as resource person for all functional areas regarding AE/PV reporting requirements
• Liaise with customers as needed
• Prepare clear periodic reports
• Support Customer audits
• Interact with various customers and stakeholders to identify and assess cases such as adverse events, product complaints, as well as other safety information.
• Submit adverse events, product complaints, and all other safety information within strict timelines via email ensuring patient confidentiality where applicable
• Prior to sending, verify the accuracy, completeness and validity of cases that have been completed by other departments
• Document new cases and follow‑up information into the safety database and the Client Relationship Management Software (CRM)
• Answer calls and emails for general PV inquiries
• Retrieve and process voice messages from the AE reporting voice mailbox

• Professional degree and/or advanced graduate degree in Health Sciences
• Three (3) to Five (5) years of Pharmacovigilance experience
• Good knowledge of Canadian GMPs, GXP, Health Canada Good Pharmacovigilance Practices, guidelines and regulations
• One (1) to three (3) years of previous leadership experience
• Excellent organizational skills and with strong and proven attention to detail
• Critical thinking skills often utilized to focus on root cause and opportunities for improvement
• Must have the ability to multitask, prioritize and schedule daily activities while with short lead times and changing customer demands
• Ability to keep tight deadlines.
• Good knowledge of Microsoft Word, Excel, and PowerPoint in a Windows environment
• Organizational skills with a strong and proven attention to detail and ability to manage several projects or tasks at once; results oriented
• Excellent oral and written communication skills and facilitation skills & the ability to work at all levels of an…