Bilingual Specialist, Pharmacovigilance

**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?**

**Shift**: 12pm to 8pm**

**Summary**

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

**What you will**do**
- 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 English and French 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.
- 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)

**What you will**need**
- 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
- Must be bilingual, proficient in both English and French (writing, reading, and speaking)
- 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 organization in English, French is required
- Team spirit, open-mindedness and ability to communicate effectively with tact and diplomacy

**Résumé**

Le Spécialiste Bilingue en Pharmacovigilance est responsable de faciliter les questions et de fournir des conseils à notre équipe de pharmacovigilance tout en jouant un rôle actif au sein de l’équipe pour la réconciliation des dossiers, les vérifications de qualité, et le soutien lors des audits, inspections, contrats et accords.

Le Spécialiste Bilingue en Pharmacovigilance sera le principal interlocuteur entre le personnel en contact avec les patients, les départements internes et les entreprises pharmaceutiques concernant les données de sécurité. Le Spécialiste Bilingue en Pharmacovigilance développera et maintiendra des rapports de suivi et d’analyse des tendances pour le département de pharmacovigilance.

**Ce que vous ferez.**
- Se conformer aux Bonnes Pratiques de Documentation en garantissant la cohérence et l’exactitude de tous les dossiers patients ainsi que tous les autres documents.
- Réaliser et documenter les rapports de réconciliation.
- Réaliser et documenter les vérifications de qualité de routine.
- Soutenir ou mener les enquêtes sur les rapports de déviation po