Bilingue Spécialiste en pharmacovigilance/ Bilingual Pharmacovigilance Specialist

4 weeks ago


Mississauga, Canada MCKESSON Full time

McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve - we care. What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow's health today, we want to hear from you.

McKesson touche la vie des patients en œuvrant dans pratiquement tous les secteurs des soins de santé dans le but d'améliorer la santé en général. Chez McKesson Canada, nous créons un impact dans la vie de 12 millions de Canadiens, chaque jour. Nous distribuons plus de produits à partir de 12 centres de distribution à 6 300 pharmacies de détail, 1 350 hôpitaux, centres de santé longue durée, cliniques et établissements de santé partout au Canada. Toutefois, nous sommes beaucoup plus qu'une entreprise de distribution. Nous avons automatisé 2 500 pharmacies de détail et distribuons annuellement plus de 100 millions de doses de médicaments grâce à nos solutions d'automatisation. Les fabricants, les fournisseurs de soins de santé et les patients comptent sur nous pour une gamme complète de services qui contribuent à la qualité et l'intégrité des soins de santé pour le bénéfice de tous.

Chez McKesson, vous participerez à la création de produits et de solutions qui contribuent à la réalisation de la mission de l'entreprise, soit améliorer la qualité de vie et faire progresser les soins de santé. Travailler ici représente une occasion d'édifier une industrie qui est vitale pour nous tous.

Résumé des fonctions

Membre essentiel de l'équipe de pharmacovigilance, le ou la spécialiste en sécurité des médicaments est responsable de l'identification, de la collecte, de la documentation et du traitement des données sur les effets indésirables, ainsi que de la production de rapports connexes, conformément aux règles de Santé Canada et aux exigences spécifiques des clients. À ce poste, vous assurerez l'entrée de données exactes et complètes sur les effets indésirables, en temps opportun. Vous appuierez aussi l'équipe de pharmacovigilance dans les activités liées à l'évaluation de la qualité et de la sécurité, aux audits internes de pharmacovigilance, à la gestion des écarts et aux enquêtes connexes.

Partie A - Responsabilités spécifiques

Gérer les données sur les effets indésirables de toutes les sources pertinentes

Veiller à ce que les effets indésirables soient traités en temps opportun, conformément aux exigences du client

Faire preuve de diligence dans les tentatives de suivi afin d'obtenir tous les renseignements requis pour le dossier

Assurer la documentation et l'archivage adéquats de tous les renseignements sur la sécurité des médicaments et de la documentation source

Consigner et présenter de façon exacte les renseignements pertinents tirés de rapports médicaux et rapports de diagnostic et préparer des sommaires des renseignements relatifs à la sécurité

Travailler de façon indépendante sur de multiples projets et collaborer avec d'autres membres de l'équipe, ainsi que des collègues d'autres disciplines

Suivre les processus établis et adopter de nouvelles pratiques et priorités au besoin

Collaborer avec les clients, s'il y a lieu, afin de maintenir les processus et stratégies, de respecter les échéances internes et externes, de signaler les problèmes potentiels et de parvenir à une résolution rapidement

Appuyer la préparation aux inspections et audits

Gérer les activités de projets spécifiques qui lui sont confiés

Partie B - Responsabilités générales

En mesure d'établir et de revoir la priorité des tâches dans un environnement en constante évolution

Se conformer aux normes professionnelles stipulées par les organes directeurs pertinents

Participer aux activités d'amélioration continue du service concernant les processus, la qualité et la formation

Contribuer à l'examen des données agrégées pour repérer les tendances du programme et les communiquer aux personnes appropriées

Maintenir l'intégrité des données du programme par un examen de la qualité de la documentation pour en assurer l'exactitude et l'exhaustivité

Assumer d'autres fonctions au besoin

Partie C - Compétences

Au moins 4 années d'expérience professionnelle en santé (professionnel de la santé agréé)

La maîtrise du français

Une expérience antérieure dans les activités de pharmacovigilance constitue un atout

La maîtrise des programmes de la suite logicielle Microsoft Office (Word, Excel, Outlook)

Un souci du détail et d'excellentes aptitudes organisationnelles

Veuillez noter : les tâches, les exigences et les responsabilités indiquées ci-dessus visent seulement à illustrer les différents types de tâches que la personne titulaire de ce poste pourrait assumer régulièrement. L'omission de fonctions ou tâches spécifiques ne les exclut pas du rôle et des responsabilités de ce poste.

McKesson is in the business of better health and we touch the lives of patients in virtually every aspect of healthcare. At McKesson Canada, we touch the lives of 12 million Canadians every day. We carry more than 35,000 products in 12 distribution centers and ultimately provide distribution to 6,300 retail pharmacies, 1,350 hospitals, long-term care centers, clinics and institutions all over Canada. But we're so much more than a distribution company. We've automated 2,500 retail pharmacies and dispense over 100 million doses a year through our automation solutions. Manufacturers, healthcare providers and patients count on us for a full range of services that contribute to the quality and safety of care for us all.

At McKesson Canada, you'll help us carry out our mission to improve lives and advance healthcare. Working here is your opportunity to shape an industry that's vital to us all.

Job Summary

The Drug Safety Specialist is an integral part of the pharmacovigilance team, and is responsible for the identification, collection, documentation, processing and reporting of adverse event data in compliance with Health Canada regulations and client specific requirements. The Drug Safety Specialist will ensure accurate and comprehensive data entry of adverse event information in a timely manner. The Drug Safety Specialist is also responsible for supporting the pharmacovigilance team in activities related to quality safety reviews, internal pharmacovigilance auditing, and deviation investigation & management.

Section A - Specific Responsibilities

  • Management of adverse events from all relevant sources
  • Ensure all adverse events are processed in a timely manner according to client requirements
  • Demonstrate diligence in follow-up attempts to ensure all necessary information for case completeness
  • Ensure adequate documentation and archiving of all drug safety information and source documentation
  • The ability to accurately record and represent relevant information from medical and diagnostic reports and prepare concise narrative summaries of safety information
  • The ability to work independently across multiple projects and work collaboratively with other team members and colleagues across disciplines
  • The ability to follow established processes and the flexibility to adopt new practices and priorities as required
  • Work with clients, as required, to ensure processes and strategies are maintained, internal and external timelines are met, potential issues are communicated, and resolution is achieved in a timely manner
  • Support inspection readiness and audits as required Manage activities in specific projects as assigned

Section B - General Responsibilities

  • Ability to prioritize and reprioritize work in a constantly changing environment
  • Adhere to professional standards as stipulated by the relevant governing professional bodies
  • Participate and assist in departmental continuous improvement activities related to process, quality, and training
  • Assist with reviews of aggregate data to identify program trends and communicate these trends appropriately
  • Maintain program data integrity through the quality review of program documentation, ensuring completeness and accuracy
  • Perform other duties as assigned

Section C - Competencies

  • 4+ years of healthcare professional experience (licensed HCP)
  • Proficiency in French language skills
  • Previous experience in pharmacovigilance activities an asset
  • Proficiency in Microsoft Office programs (Word, Excel, Outlook)
  • Attention to detail and excellent organizational skillPlease Note: The duties, requirements and responsibilities listed above are intended only as an illustration of the various types of work-related tasks that may be performed regularly. The omission of specific statements of duties does not exclude them from the roles and responsibilities of this position

The incumbent of this position will provide daily support to internal and/or external clients outside Quebec and/or in the United States. Therefore, he/she must be proficient in spoken and written English. Please note that the number of positions requiring English language skills has been limited where possible.

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