Bilingue Spécialiste Pharmacovigilance / Pharmacovigilance Specialist
Mississauga, Canada, Saint-Laurent, Canada Job ID JR0143084 Category Regulatory Monitoring, Compliance & Legal Post Date Mar. 04, 2026McKesson 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.
Résumé du poste
Le Spécialiste en pharmacovigilance est responsable d’assurer la sécurité et l’utilisation appropriée des produits de McKesson Canada en réalisant des activités clés de pharmacovigilance. Ce rôle comprend la collecte, l’évaluation et la déclaration des effets indésirables, en conformité avec les réglementations nationales et internationales ainsi que les politiques internes.
Responsabilités du poste
- Traiter les rapports individuels de sécurité des cas (ICSR) provenant de diverses sources, incluant la saisie de données, la rédaction de narratifs, le codage des effets indésirables avec MedDRA et l’évaluation de la causalité.
- Effectuer une revue et une analyse approfondies des informations de sécurité afin d’identifier des signaux potentiels et des tendances.
- Préparer et soumettre les rapports de sécurité accélérés et périodiques aux autorités réglementaires (ex. : Santé Canada) dans les délais requis.
- Collaborer avec les départements internes (ex. : Affaires médicales, Affaires réglementaires, Assurance qualité) et des partenaires externes sur les sujets liés à la pharmacovigilance.
- Répondre aux demandes de renseignements des professionnels de la santé, des consommateurs et des organismes de réglementation concernant la sécurité des produits.
- Participer à l’élaboration et à la mise à jour des procédures opératoires normalisées (SOP) et des instructions de travail en pharmacovigilance.
- Contribuer aux audits et inspections de pharmacovigilance, en veillant au respect des réglementations locales et internationales.
- Participer aux activités de gestion des risques et à la préparation des plans de gestion des risques (PGR) selon les besoins.
- Se tenir à jour concernant les réglementations, lignes directrices et meilleures pratiques en pharmacovigilance.
Qualifications requises
- Baccalauréat en sciences de la vie (ex. : Pharmacie, Soins infirmiers, Biologie, Pharmacologie) ou équivalent.
- Minimum de 2 à 3 ans d’expérience en pharmacovigilance dans l’industrie pharmaceutique ou des soins de santé.
- Solide compréhension des réglementations et lignes directrices nationales (ex. : Santé Canada) et internationales (ex. : ICH, EMA, FDA) en matière de pharmacovigilance.
- Maîtrise des systèmes et bases de données de déclaration des effets indésirables (ex. : Argus, ArisG).
- Expérience avec la terminologie médicale et les systèmes de codification médicale (ex. : MedDRA, WHO-DD).
- Excellentes aptitudes analytiques, de résolution de problèmes et de pensée critique.
- Compétences exceptionnelles en communication écrite et verbale en anglais et en français (bilinguisme fortement souhaité).
- Capacité à gérer plusieurs priorités, à travailler de manière autonome et à respecter des délais stricts.
- Grand souci du détail, précision et rigueur dans la gestion des données.
- Maîtrise de la suite Microsoft Office (Word, Excel, PowerPoint).
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Job Summary
The Pharmacovigilance Specialist is responsible for ensuring the safety and appropriate use of McKesson Canada's products by performing key pharmacovigilance activities. This role involves the collection, assessment, and reporting of adverse events in compliance with national and international regulations and internal policies.
Job Responsibilities
- Process individual case safety reports (ICSRs) from various sources, including data entry, narrative writing, MedDRA coding of adverse events, and causality assessment.
- Conduct thorough review and analysis of safety information, identifying potential safety signals and trends.
- Prepare and submit expedited and periodic safety reports to regulatory authorities (e.g., Health Canada) within specified timelines.
- Collaborate with internal departments (e.g., Medical Affairs, Regulatory Affairs, Quality Assurance) and external partners on pharmacovigilance-related matters.
- Respond to inquiries from healthcare professionals, consumers, and regulatory bodies regarding product safety.
- Participate in the development and maintenance of pharmacovigilance standard operating procedures (SOPs) and work instructions.
- Assist with pharmacovigilance audits and inspections, ensuring compliance with global and local regulations.
- Contribute to risk management activities and the preparation of risk management plans (RMPs) as needed.
- Stay current with pharmacovigilance regulations, guidelines, and industry best practices.
Job Qualifications
- Bachelor's degree in a life science discipline (e.g., Pharmacy, Nursing, Biology, Pharmacology) or equivalent.
- Minimum of 2-3 years of experience in pharmacovigilance within the pharmaceutical or healthcare industry.
- Strong understanding of national (e.g., Health Canada) and international (e.g., ICH, EMA, FDA) pharmacovigilance regulations and guidelines.
- Proficiency in adverse event reporting systems and databases (e.g., Argus, ArisG).
- Experience with medical terminology and medical coding systems (e.g., MedDRA, WHO-DD).
- Excellent analytical, problem-solving, and critical thinking skills.
- Exceptional written and verbal communication skills in English and French (bilingualism is a strong asset).
- Ability to manage multiple priorities, work independently, and meet strict deadlines.
- Detail-oriented with a high degree of accuracy and data integrity.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
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.
We are proud to offer a competitive compensation package at McKesson as part of our Total Rewards. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. The pay range shown below is aligned with McKesson's pay philosophy, and pay will always be compliant with any applicable regulations. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. For more information regarding benefits at McKesson, please click here.
Our Base Pay Range for this position
$74,100 - $123,500McKesson has become aware of online recruiting-related scams in which individuals who are not affiliated with or authorized by McKesson are using McKesson’s (or affiliated entities, like CoverMyMeds or RxCrossroads) name in fraudulent emails, job postings or social media messages. In light of these scams, please bear the following in mind:
McKesson Talent Advisors will never solicit money or credit card information in connection with a McKesson job application.
McKesson Talent Advisors do not communicate with candidates via online chatrooms or using email accounts such as Gmail or Hotmail. Note that McKesson does rely on a virtual assistant (Gia) for certain recruiting-related communications with candidates.
McKesson job postings are posted on our career site: careers.mckesson.com.
McKesson is an Equal Opportunity Employer
McKesson provides equal employment opportunities to applicants and employees, without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age, genetic information, or any other legally protected category. For additional information on McKesson’s full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page.
McKesson welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. If you require accommodation please contact us by sending an email to Disability_Accommodation@McKesson.com.
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McKesson has become aware of online recruiting-related scams in which individuals who are not affiliated with or authorized by McKesson are using McKesson’s (or affiliated entities, like CoverMyMeds or RxCrossroads) name in fraudulent emails, job postings or social media messages. In light of these scams, please bear the following in mind:
- McKesson Talent Advisors will never solicit money or credit card information in connection with a McKesson job application.
- McKesson Talent Advisors do not communicate with candidates via online chatrooms or using email accounts such as Gmail or Hotmail. Note that McKesson does rely on a virtual assistant (Gia) for certain recruiting-related communications with candidates.
- McKesson job postings are posted on our career site: careers.mckesson.com.
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