Spécialiste en pharmacovigilance/Pharmacovigilance Specialist

at  McKesson

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 35 000 produits à partir de 17 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.

SECTION C – POSITION KEY REQUIREMENTS

Education:

• M.D. Degree, or degree in pharmacy, nursing or related disciplines. For M.D., minimum 1 years’ and for other degrees, minimum 3 years’ total experience in MI and PV, or equivalent relevant industry experience considered.

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, agInquirer and ARISg experience 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.
• Bilingualism (French / English) is a requirement in this position.

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.
  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.
  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.

Le.la titulaire de ce poste aura à soutenir de façon quotidienne des clients internes et/ou externes à l’extérieur du Québec et/ou aux États-Unis. Par conséquent, ce poste requiert une maîtrise de l’anglais à l’écrit et à l’oral. Veuillez noter que le nombre de postes dont les tâches requièrent une connaissance de la langue anglaise a été restreint dans la mesure du possible.
At McKesson, we care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse employee population and ensure they are the healthiest versions of themselves. For more information regarding benefits at McKesson, please click here.
As part of Total Rewards, we are proud to offer a competitive compensation package at McKesson. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.

SECTION A – SPECIFIC RESPONSIBILITIES

• Monitor and manage PV dedicated email accounts, incoming faxes and telephone calls.
• 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.
• Contribute to the development, revision and maintenance of standard medical responses, FAQ letters and other medical information (MI) resources.
• Ensure responses are provided in an accurate, balanced and timely manner in accordance with SOPs and regulatory guidelines.
• 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.
• 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.
• 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.
• Contribute to regulatory inspections/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

• Contribute to the development of training presentations and providing 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, to ensure the continuity of daily activities.
• Other PV activities appropriate to experience and expertise.