Permanent, Full Time ______________ Pharmacovigilance (PV) activities are critical and serve as a foundation to all that we do at Pfizer. As part of their role, SOs review, analyze, prepare, and complete safety-related reports to determine the safety profile of Pfizer products and to meet regulatory requirements. A key responsibility for this position is the clinical assessment of adverse event listedness using Canadian Product Monographs to support Health Canada expedited reporting requirements.

This requires the ability to analyze medical terms and concepts, accurately interpret clinical information, and apply sound scientific and clinical judgment in a regulatory environment. They also provide and share their specific pharmacovigilance knowledge and experience related to PV regulations and quality activities. If you are looking for an opportunity to actively participate in such activities with the goal of protecting patient safety, then this might be the dream job for you.

Organize, manage and actively carry out as appropriate, local PV activities, such as adverse event monitoring, safety reporting, risk management, local safety monitoring activities as required by local agency, local contractual agreements, process documentation and training, inspection preparedness, and any other required country-specific safety activity. Perform scientific and clinical assessment of adverse event listedness using Canadian Product Monographs and other applicable safety reference documents to support Health Canada expedited Individual Case Safety Report (ICSR) submissions. Apply clinical judgment to evaluate medical case information, determine expectedness, and support regulatory reporting decisions.

Serve as a local subject matter expert for adverse event listedness assessment and support the interpretation of safety information in collaboration with cross-functional partners. Ensure regulatory compliance with timelines for individual expedited case report submissions and timely delivery of information for aggregate reports and other regulatory documents as requested Review processed cases to verify accuracy, consistency and compliance with process and regulatory requirements. Analyze and monitor activities, define and implement corrective actions, where applicable Develop and maintain expertise of applicable corporate policies and local regulations, guidelines and Standard Operating Procedures.

Leverage and apply required judgment, issue resolution and negotiation skill-sets necessary to play a leadership role as a subject matter expert and/or project lead across the Global PV organization Act as subject matter expert for suppliers and stakeholders, locally, concerning safety-related issues; and, liaise with key partners regarding safety data collection and handling Identify and report adverse events and product complaints as per Corporate procedure, including Your Reporting Responsibilities (YRR) training. Participate and ensure as required proper process documentation and training, risk management plan and/or aggregate report review, inspection preparedness, and any other required country-specific safety activity. Promote/participate, as appropriate, in local, internal, and external safety activities Health Care Professional qualification (e.g., physician, pharmacist, nurse or other regulated healthcare professional) strongly preferred.

Candidates must demonstrate the ability to critically evaluate medical information and apply clinical judgment in safety and regulatory assessments. Relevant experience assessing adverse event listedness/expectedness using Product Monographs, Core Data Sheets, SmPCs, or comparable labeling documents is highly desirable. Minimum 4 years’ experience in pharmacovigilance and/or data management.

Solid working knowledge of pharmacovigilance concepts Solid knowledge of national and international PV regulations. Solid understanding of quality related activities (audits, inspections) Solid knowledge of global regulations and guidelines for drug development. Ability to work independently to accomplish team goals with minimal supervision Understanding and ability to use computer technology, management of relational database systems Bilingualism (French and English) is required.

We are proud to offer employees a flexible working model that is grounded on empowering colleagues to design their workdays so that they can maximize their productivity, enhance their work-life balance and support a way of working that fosters innovation and patient-centricity. Currently, our employees are expected to be on-site 2.5 -3 days per week blending on-site collaboration and connection with off-site remote working when it makes business sense to do so. At Pfizer, we embrace diversity and inclusion for innovation and growth.

We are committed to building inclusive teams and an equitable workplace for our employees to bring their true selves to work.



Une responsabilité clé de ce poste consiste à effectuer l'évaluation clinique du caractère attendu ou inattendu des manifestations indésirables à l'aide des monographies de produit canadiennes afin de soutenir les exigences de déclaration accélérée d’évènements indésirables à Santé Canada. Cette responsabilité exige la capacité d'analyser les termes et concepts médicaux, d'interpréter avec précision l'information clinique et d'exercer un jugement scientifique et clinique solide dans un contexte réglementaire.

Par ailleurs, ils fournissent et transmettent leurs connaissances spécifiques en matière de pharmacovigilance ainsi que leur expérience en lien avec la réglementation liée à la pharmacovigilance et les activités relatives à la qualité. Voici à quoi ressemblera votre quotidien si vous relevez ce défi : Organiser, gérer et mettre en œuvre de façon appropriée des activités locales de pharmacovigilance, telles que la déclaration, l’analyse et la surveillance des manifestations indésirables, les activités locales liées aux rapports et à la surveillance de l’innocuité qui sont requises par les organismes de réglementation et/ou les ententes contractuelles locales. Réaliser l'évaluation scientifique et clinique du caractère attendu ou inattendu des manifestations indésirables à l'aide des monographies de produit canadiennes et d'autres documents de référence en innocuité applicables afin de soutenir les déclarations d’évènements indésirables à Santé Canada.

Exercer son jugement clinique pour évaluer l'information médicale des cas, déterminer le caractère attendu ou inattendu des manifestations indésirables et appuyer les décisions liées aux déclarations réglementaires. Agir à titre d'expert local en matière d'évaluation du caractère attendu ou inattendu des manifestations indésirables et soutenir l'interprétation des données d'innocuité en collaboration avec des partenaires interfonctionnels. Participer et veiller, tel que requis, à la tenue appropriée de la documentation et de la formation sur les processus, du plan de gestion des risques et/ou de la revue de rapports de données groupées, de la préparation aux inspections et de toute autre activité liée à l’innocuité qui est obligatoire au pays.

Assurer le respect réglementaire des délais liés à l’envoi des rapports abrégés de cas individuels et à la transmission rapide de l’information relative aux rapports de données groupées et aux autres documents requis par la réglementation, au besoin. Utiliser et appliquer le jugement nécessaire ainsi que les compétences en matière de résolution de problèmes et de négociation requises pour faire preuve de leadership à titre d’expert ou de responsable de projet au Service de l’innocuité des médicaments du Groupe mondial. Agir en tant qu’expert local auprès des fournisseurs et des intervenants en ce qui concerne les problèmes d’innocuité et assurer la liaison avec les partenaires clés concernant la collecte et le traitement de données relatives à l’innocuité.

Qualification de professionnel de la santé (p. ex. médecin, pharmacien, infirmier ou autre professionnel de la santé réglementé) fortement privilégiée. Les candidats doivent démontrer leur capacité à évaluer de façon critique l'information médicale et à appliquer leur jugement clinique dans le cadre d'évaluations liées à l'innocuité et aux exigences réglementaires. Une expérience pertinente dans l'évaluation du caractère attendu ou inattendu des manifestations indésirables à l'aide de monographies de produit, de Core Data Sheets (CDS), de résumés des caractéristiques du produit (RCP/SmPC) ou d'autres documents d'information sur le produit comparables constitue un atout important.

Minimum de 4ans d’expérience en pharmacovigilance et/ou en gestion de données Solide compréhension des activités liées à la qualité (vérifications, inspections) Capacité à travailler de manière autonome pour atteindre des objectifs d’équipe avec une supervision minimale Capacité à comprendre et à utiliser la technologie informatique et à gérer des systèmes de bases de données relationnelles Bilinguisme (français et anglais) – le ou la titulaire du poste doit pouvoir bien communiquer en anglais, car ses fonctions exigent des interactions avec des intervenants et collègues se trouvant à l’extérieur du Québec ou du Canada. Nous sommes fiers d’offrir à nos employés un modèle de travail flexible qui leur permet de planifier leurs journées afin de maximiser leur productivité, d’atteindre un meilleur équilibre entre leur vie personnelle et leur vie professionnelle et de favoriser une nouvelle façon de travailler, qui sera centrée sur les patients et stimulera l’innovation. Actuellement, nos employés sont tenus de travailler sur place 2.5à 3jours par semaine, en combinant la collaboration et la communication en présentiel et le télétravail, lorsque cela est approprié pour l’entreprise.





L’échelle salariale fournie s’applique seulement au Canada, et ne s’applique à aucun autre endroit à l’extérieur du Canada. _____________________________ Safety Officer (SO) / Manager level Pharmacovigilance Pharmacovigilance (PV) activities are critical and serve as a foundation to all that we do at Pfizer. As part of their role, SOs review, analyze, prepare, and complete safety-related reports to determine the safety profile of Pfizer products and to meet regulatory requirements. A key responsibility for this position is the clinical assessment of adverse event listedness using Canadian Product Monographs to support Health Canada expedited reporting requirements.

This requires the ability to analyze medical terms and concepts, accurately interpret clinical information, and apply sound scientific and clinical judgment in a regulatory environment. They also provide and share their specific pharmacovigilance knowledge and experience related to PV regulations and quality activities. If you are looking for an opportunity to actively participate in such activities with the goal of protecting patient safety, then this might be the dream job for you.

Organize, manage and actively carry out as appropriate, local PV activities, such as adverse event monitoring, safety reporting, risk management, local safety monitoring activities as required by local agency, local contractual agreements, process documentation and training, inspection preparedness, and any other required country-specific safety activity. Perform scientific and clinical assessment of adverse event listedness using Canadian Product Monographs and other applicable safety reference documents to support Health Canada expedited Individual Case Safety Report (ICSR) submissions. Apply clinical judgment to evaluate medical case information, determine expectedness, and support regulatory reporting decisions.

Serve as a local subject matter expert for adverse event listedness assessment and support the interpretation of safety information in collaboration with cross-functional partners. Ensure regulatory compliance with timelines for individual expedited case report submissions and timely delivery of information for aggregate reports and other regulatory documents as requested Review processed cases to verify accuracy, consistency and compliance with process and regulatory requirements. Analyze and monitor activities, define and implement corrective actions, where applicable Develop and maintain expertise of applicable corporate policies and local regulations, guidelines and Standard Operating Procedures.

Leverage and apply required judgment, issue resolution and negotiation skill-sets necessary to play a leadership role as a subject matter expert and/or project lead across the Global PV organization Act as subject matter expert for suppliers and stakeholders, locally, concerning safety-related issues; and, liaise with key partners regarding safety data collection and handling Identify and report adverse events and product complaints as per Corporate procedure, including Your Reporting Responsibilities (YRR) training. Participate and ensure as required proper process documentation and training, risk management plan and/or aggregate report review, inspection preparedness, and any other required country-specific safety activity. Promote/participate, as appropriate, in local, internal, and external safety activities Health Care Professional qualification (e.g., physician, pharmacist, nurse or other regulated healthcare professional) strongly preferred.

Candidates must demonstrate the ability to critically evaluate medical information and apply clinical judgment in safety and regulatory assessments. Relevant experience assessing adverse event listedness/expectedness using Product Monographs, Core Data Sheets, SmPCs, or comparable labeling documents is highly desirable. Minimum 4 years’ experience in pharmacovigilance and/or data management.

Solid working knowledge of pharmacovigilance concepts Solid knowledge of national and international PV regulations. Solid understanding of quality related activities (audits, inspections) Solid knowledge of global regulations and guidelines for drug development. Ability to work independently to accomplish team goals with minimal supervision Understanding and ability to use computer technology, management of relational database systems Bilingualism (French and English) is required.

We are proud to offer employees a flexible working model that is grounded on empowering colleagues to design their workdays so that they can maximize their productivity, enhance their work-life balance and support a way of working that fosters innovation and patient-centricity. Currently, our employees are expected to be in office 2.5 -3 days per week blending on-site collaboration and connection with off-site remote working when it makes business sense to do so. At Pfizer, we embrace diversity and inclusion for innovation and growth.

We are committed to building inclusive teams and an equitable workplace for our employees to bring their true selves to work. Chez Pfizer, nous accueillons la diversité et l'inclusion pour stimuler l'innovation et la croissance. Medical #

📌 Agent - Innocuité des médicaments / Safety Officer (Montreal)
🏢 Pfizer, S.A. de
📍 Montreal