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 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. 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 transcribe French voice messages from the AE reporting voicemailbox 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 Rsum Le Spcialiste Bilingue en Pharmacovigilance est responsable de faciliter les questions et de fournir des conseils notre quipe de pharmacovigilance tout en jouant un rle actif au sein de l''quipe pour la rconciliation des dossiers, les vrifications de qualit, et le soutien lors des audits, inspections, contrats et accords. Le Spcialiste Bilingue en Pharmacovigilance sera le principal interlocuteur entre le personnel en contact avec les patients, les dpartements internes et les entreprises pharmaceutiques concernant les donnes de scurit. Le Spcialiste Bilingue en Pharmacovigilance dveloppera et maintiendra des rapports de suivi et d''analyse des tendances pour le dpartement de pharmacovigilance. Ce que vous ferez. Se conformer aux Bonnes Pratiques de Documentation en garantissant la cohrence et l''exactitude de tous les dossiers patients ainsi que tous les autres documents. Raliser et documenter les rapports de rconciliation. Raliser et documenter les vrifications de qualit de routine. Soutenir ou mener les enqutes sur les rapports de dviation pour les retards de signalement de cas et d''autres activits non conformes lies aux PSP. Aider dvelopper et mettre en uvre des CAPA pour assurer la conformit avec les exigences du programme. Rviser et mettre jour les Procdures Opratoires Standard, les Instructions de Travail et les Documents de Rfrence selon les besoins. Fournir des formations spcifiques au programme sur les EI/PV aux nouveaux membres de l''quipe (PCS, Remboursement, Responsables de Cas). Soutenir le Manager, Pharmacovigilance, dans les tches assignes. Servir de personne-ressource pour tous les domaines fonctionnels concernant les exigences de signalement EI/PV en anglais et en franais. Assurer la liaison avec les clients si ncessaire. Prparer des rapports priodiques clairs. Soutenir les audits clients. Interagir avec divers clients et parties prenantes pour identifier et valuer les cas tels que les vnements indsirables, les plaintes concernant les produits, ainsi que d''autres informations relatives la scurit. Soumettre les vnements indsirables, les plaintes concernant les produits et toutes autres informations de scurit dans des dlais stricts par e-mail, en garantissant la confidentialit des patients, le cas chant. Avant d''envoyer, vrifier l''exactitude, la compltude et la validit des cas complts par d''autres dpartements. Documenter les nouveaux cas et les informations de suivi dans la base de donnes de scurit et le logiciel de gestion des relations clients (CRM). Rpondre aux appels et aux e-mails pour les demandes gnrales lies la pharmacovigilance. Rcuprer et transcrire les messages vocaux en franais du rpondeur pour le signalement des EI. Ce dont vous aurez besoin. Diplme professionnel et/ou diplme d''tudes suprieures en sciences de la sant Trois (3) cinq (5) ans d''exprience en pharmacovigilance Bonne connaissance des BPF canadiennes, des GXP, des Bonnes Pratiques de Pharmacovigilance de Sant Canada, des lignes directrices et des rglements Doit tre bilingue, matrisant la fois l''anglais et le franais (crit, lu et parl) Un (1) trois (3) ans d''exprience pralable en leadership Excellentes comptences organisationnelles avec une forte attention aux dtails Capacits de pense critique frquemment utilises pour se concentrer sur les causes profondes et les opportunits d''amlioration Doit tre capable de grer plusieurs tches simultanment, de prioriser et de planifier les activits quotidiennes tout en respectant des dlais courts et des demandes clients changeantes Capacit respecter des dlais serrs. Bonne connaissance de Microsoft Word, Excel et PowerPoint dans un environnement Windows Comptences organisationnelles avec une attention minutieuse aux dtails et la capacit de grer plusieurs projets ou tches en mme temps ; orient vers les rsultats Excellentes comptences en communication orale et crite et comptences en animation, avec la capacit de travailler tous les niveaux d''une organisation en anglais, le franais tant requis Esprit d''quipe, ouverture d''esprit et capacit communiquer efficacement avec tact et diplomatie. 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: * Regular 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. Hiring Range / chelle salariale l''embauche : $60, $82,500.00 / 60.000,00$ ,00$ (per year / par an) A candidate''s experience and knowledge as well as the geographical region in which the position is located may be factored into the pay a candidate receives for this position. This posting is for an existing vacancy. The Company uses artificial intelligence for the purpose of screening, assessing and/or selecting applicants for this position. / L''exprience et les connaissances d''un candidat ainsi que la rgion gographique dans laquelle le poste est situ peuvent tre prises en compte dans la rmunration qu''un candidat reoit pour ce poste. Cette offre d''emploi concerne un poste vacant existant. L''entreprise utilise l''intelligence artificielle dans le but de filtrer, d''valuer et/ou de slectionner les candidats ce poste. EN SS #ON
Job Title
Bilingual Pharmacovigilance Specialist