Pharmacovigilance Specialist

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.

Why this role is important?

Summary

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.

What you will do

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

What you will need

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

Why work at Shoppers Drug Mart?

Acting as consultants, supporting internal customers and the Associate-Owners, you will get experience unique to the retail industry while working for an award-winning national brand. Benefit from a purchase discount program, competitive pay and online learning through Academy.

Take ownership of your work and find more ways to care about your work, co-workers, customers and community.

How You’ll Succeed:

At Shoppers Drug Mart Inc., we seek great people to continually strengthen our culture. We believe great people model our values, are authentic, build trust and make connections.

If that sounds like you, and you are open-minded, responsive to change and up to the challenges provided in a fast-paced retail environment, apply today.

Employment Type:

Full time

Type of Role:

Temporary with Benefits (Fixed Term)

Shoppers Drug Mart Inc. recognizes Canada's diversity as a source of national pride and strength. We have made it a priority to reflect our nation’s evolving diversity in the products we sell, the people we hire, and the culture we create in our organization. Accommodation is available upon request for applicants with disabilities in the recruitment and assessment process and when hired.

In addition, we believe that compliance with laws is about doing the right thing. Upholding the law is part of our Code of Conduct – it reinforces what our customers and stakeholders expect of us.

Please Note: If you have Employee Self Service (ESS) on Workday, apply to this job via the Workday application.