No more applications are being accepted for this job

Bilingue Spécialiste Senior en Pharmacovigilance/Bilingual Sr. Pharmacovigilance Specialist - Montréal, Canada - McKesson

McKesson Montréal, Canada

1 month ago

Description

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 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

Support daily Medical Information and Pharmacovigilance activities
Respond, database and process all unsolicited medical inquiries (including adverse event (AE) reports and product quality complaints (PQC from healthcare professionals (HCPs), consumers, field staff and other business partners (BPs) in a timely manner and with nominal supervision.
Develop, review and maintain the standard medical responses, FAQ letters and other medical information (MI)resources.
Process Individual Case Safety Reports (ICSRs) in compliance with applicable regulations, SOPs and project specific operational agreements. That includes data entry in the electronic database, tracking systems and/or project specific report forms, MedDRA coding, seriousness, expectedness and causality assessments, preparation of high-quality case narratives, generation of safety reports and their submission to regulatory authorities and/or BPs. Conduct follow-up of cases if needed.
Perform Quality Control on cases processed by other team members.
Maintain working knowledge of regulatory requirements, guidance documents, SOPs, work instructions and other internal documents for end-to-end case management and ensure compliance with global regulations and guidelines. Assist in review and updating of internal PV policies, SOPs and work instructions as needed.
Perform reconciliation of PV activities with stakeholders.
Develop, review and update the PV Agreements and SDEAs (Safety Data Exchange Agreements) with BPs to ensure that they follow the company SOPs and country specific requirements.
Perform the review and assessment of the validity of literature abstracts and articles for safety information and ICSRs.
Lead aggregate safety data review activities and coordinate safety surveillance activities. Create and review Safety Summary Reports (SSRs) in compliance with Health Canada regulations, review as per calendar and follow up with BPs for compliance as needed. Prepare ICSRs or safety summaries for SSRs as needed or requested.
Perform Canada Vigilance Screening and Signal Detection activities
Ensure regulatory compliance with timelines for ICSR submissions and provide assistance and timely delivery of information for SSRs, ad hoc report compilations, and other regulatory documents, as requested. Maintaining various metrics for the department to track compliance.
Participate and assist in preparations for regulatory inspection/internal audits/BPs audits.
Serve as a back-up person in case of the absence of any PV&MI team member to ensure the continuity of daily activities.
Serve as a back-up person in case of the absence of Manager, Corporate Pharmacovigilance and Drug Safety if a Subject Matter Expert (SME), to ensure the continuity of daily activities.

Section B - General Responsibilities

Develop and conduct training presentations and on-the-job training of PV and non-PV staff, such as CS employees, sale representatives, front desk employees, BPs, etc including annual refresh training. Mentoring less-experienced PV&MI team members.
Serve as the back-up person in case of the absence of any PV&MI team member, including the Manager PV, to ensure the continuity of daily activities.
Other PV activities appropriate to experience and expertise.

Section C - Position Key Requirements

Education: M.D. Degree, or degree in pharmacy, nursing or related disciplines.
For M.D., minimum 3 years' and for other degrees, minimum 5 years' total experience in MI and PV, or equivalent relevant industry experience considered.
Bilingualism (French / English) is a requirement in this position.

Technical and Soft Skills:

Strong knowledge of Canadian PV regulations. Thorough knowledge of medical terminology essential.
Working knowledge of MedDRA coding principles and practical applications
Computer literate with the ability to work within medical information and safety databases, ARIS Global databases would be preferred.
Excellent verbal and written communication skills including excellent telephone etiquette. Should be comfortable in speaking with HCPs.
Excellent attention to detail and accuracy maintaining consistently high-quality standards.

Management skills:

Ability to work flexibly, organize own workload and effectively manage competing priorities.
Strong decision making, problem-solving and excellent time management skills.
Ability to work independently, follow instructions/guidelines and demonstrate initiative.
Previous experience in medical device is an asset.
Occasional travel may be required.

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees

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.

Partie A - Responsabilités spécifiques

Appuyer les activités quotidiennes relatives à l'information médicale et à la pharmacovigilance
Traiter et inscrire à la base de données toutes les demandes médicales non sollicitées de professionnels de la santé, de consommateurs, du personnel sur le terrain et d'autres partenaires commerciaux et y répondre en temps opportun avec un minimum de supervision (y compris les rapports sur les événements indésirables et les plaintes sur la qualité du produit).
Élaborer, réviser et tenir à jour les réponses-types médicales, les lettres de FAQ et les autres ressources de renseignements médicaux.
Traiter les rapports d'innocuité sur les cas individuels conformément aux règlements applicables, aux procédures normales d'exploitation et aux accords opérationnels spécifiques à un projet. Ceci comprend l'entrée de données dans la base de données électronique; les systèmes de suivi ou le formulaire de rapport spécifique à un projet; le codage MedDRA; les évaluations de la gravité, de la prévisibilité et de la causalité; la préparation d'exposés des faits de grande qualité; la production de rapports d'innocuité et leur soumission aux organismes de réglementation ou aux partenaires commerciaux. Effectuer un suivi des dossiers au besoin.