Agent – Innocuité des médicaments / Safety Officer

Pfizer, S.A. de C.V; Kirkland; Hybrid; CAD 92,000 - 154,000; Full time

Job summary

A leading company in the pharmaceuticals sector is seeking a Safety Officer to oversee pharmacovigilance activities crucial for patient safety. The role requires significant experience and knowledge of regulatory requirements. With a competitive salary range, this position also offers a flexible working model and an opportunity to contribute to meaningful patient care.

Benefits

Flexible working model

Health and disability insurance

Parental leave policy

Qualifications

• Minimum 4 years’ experience in pharmacovigilance or data management.
• Understanding of national and international PV regulations.
• Ability to work independently and in a the team.

Responsibilities

• Organize and manage local PV activities.
• Ensure regulatory compliance for individual expedited case report submissions.
• Review processed cases for accuracy and compliance.

Skills

Knowledge of pharmacovigilance concepts

Analytical skills

Communication skills

Teamwork

Education

Health Care Professional or equivalent experience

Job description

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.

To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

Posting closing date: June 24th, 2025

Status: Regular, Full Time

(English to follow)

_____________________________

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. 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.

What your day to day will look like taking on this challenge:

• 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.
• 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
• Identifies and reports 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

What we think you will need to be successful in this role:

• Health Care Professional or equivalent experience preferred
• 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
• Demonstrated ability to foster teamwork, including in remote working environment
• Understanding and ability to use computer technology, management of relational database systems

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.

The annual base salary for this position ranges from $ 92,100 to $153,500.

The salary range provided applies to Canada only and does not apply to any other locations outside of Canada.

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.

We also strive to provide an accessible candidate experience for our prospective employees with different abilities. Please let us know if you need any accommodations during the recruitment process.

Date de fin d’affichage : le 24 juin 2025

Posting closing date: June 24th, 2025

Statut : Régulier, temps plein

Status: Regular, Full Time

(English to follow)

Agent(e) ̶ Innocuité des médicaments/ Grade de gestionnaire, pharmacovigilance

Les activités de pharmacovigilance sont essentielles et constituent le fondement de tout ce que nous entreprenons chez Pfizer. Dans le cadre de leurs fonctions, les agent(e)s ̶ Innocuité des médicaments révisent, analysent, préparent et rédigent des rapports liés à l’innocuité afin de déterminer le profil d’innocuité des produits de Pfizer et de répondre aux exigences réglementaires. 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. Si vous êtes à la recherche d’une occasion de participer activement à de telles activités avec l’objectif de protéger la sécurité des patients, il s’agit peut-être de l’emploi idéal pour vous.

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.
• Passer en revue les cas traités afin d’en vérifier l’exactitude, la cohérence et la conformité quant aux processus et aux exigences réglementaires.
• 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.
• Analyser et surveiller les activités, et définir et appliquer les mesures correctives nécessaires.
• Développer et maintenir une expertise en matière de politiques d’entreprise, de réglementations régionales, de lignes directrices et de modes opératoires normalisés applicables.
• 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 en matière de collecte et de traitement de données relatives à l’innocuité.

Ce que nous croyons nécessaire pour occuper ce poste avec succès :

• Être un professionnel de la santé ou détenir une expérience pertinente équivalente
• Minimum de 4ans d’expérience en pharmacovigilance et/ou en gestion de données
• Solide connaissance pratique des concepts de pharmacovigilance
• Solide connaissance des réglementations nationales et internationales en matière de pharmacovigilance
• Solide compréhension des activités liées à la qualité (vérifications, inspections)
• Solide connaissance des réglementations et des directives mondiales en matière de mise au point de médicaments
• Capacité à travailler de manière autonome pour atteindre des objectifs d’équipe avec une supervision minimale
• Capacité avérée à favoriser le travail d’équipe, y compris dans un environnement de travail à distance
• 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 flexiblequi leur permetde 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.

Le salaire annuel de base pour ce poste varie de 92,100 $ à 153,500$ .

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. 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.

What your day to day will look like taking on this challenge:

• 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.
• 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
• Identifies and reports 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

What we think you will need to be successful in this role:

• Health Care Professional or equivalent experience preferred
• 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
• Demonstrated ability to foster teamwork, including in remote working environment
• Understanding and ability to use computer technology, management of relational database systems

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.

The annual base salary for this position ranges from $ 92,100 to $153,500.

The salary range provided applies to Canada only and does not apply to any other locations outside of Canada.

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.

We also strive to provide an accessible candidate experience for our prospective employees with different abilities. Please let us know if you need any accommodations during the recruitment process.

Chez Pfizer, nous accueillons la diversité et l'inclusion pour stimuler l'innovation et la croissance. Nous sommes déterminés à créer des équipes inclusives et un milieu de travail équitable pour que nos employés puissent exprimer leur vraie personnalité au travail.

Nous nous efforçons également d'offrir une expérience de candidature accessible à nos employés potentiels ayant des habiletés différentes. N'hésitez pas à nous faire savoir si vous avez besoin de mesures d’adaptation au cours du processus de recrutement.

Medical#LI-PFE

Breakthroughs that change patients’ lives

Research confirms what intuition tells us: that purpose-driven companies perform better, are more innovative, attract and retain the best people, and know how to unleash the power of those people. Pfizer’s purpose—Breakthroughs that change patients' lives—fuels everything we do and reflects our passion for building on our legacy as one of the greatest contributors of good to the world.

Each word in our purpose has meaning and reflects the value we strive to bring to patients and society:

“Breakthroughs” - These are the innovations, scientific and commercial, that we seek to deliver every day. All colleagues, regardless of role, level or location, strive for breakthroughs every day.

“Change” - We want to do more than simply improve patients’ medical conditions; we want to dramatically change their lives for the better.

“Patients’ lives” - We consider not only patients, but everyone they touch—including their families, caregivers, and friends—and everything they love to do. It’s an intentionally holistic view.

Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.

Every decision we make and every action we take is done with the patient in mind—and to nurture an environment where breakthroughs can thrive.

Our Values

To fully realize Pfizer’s purpose, we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.

The “how” is represented by four simple, powerful values—courage, excellence, equity, and joy—that define our company and our culture.

Courage: Breakthroughs start by challenging convention, especially in the face of uncertainty or adversity. This happens when we think big, speak up, and are decisive.

Excellence: We can only change patients’ lives when we perform at our best together. This happens when we focus on what matters, agree who does what, and measure our outcomes.

Equity: We believe that every person deserves to be seen, heard, and cared for. This happens when we are inclusive, act with integrity, and reduce healthcare disparities.

Joy: We give ourselves to our work, but it also gives to us. We find joy when we take pride, recognize one another, and have fun.

Benefits at Pfizer

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Our Pay for Performance Philosophy and Practices reward colleagues based on the contributions they make to our business.

Our Competitive Benefits Programs help our colleagues by:

• Promoting Health and Wellness to help colleagues maintain and improve their physical and mental wellbeing . Pfizer offerings include health and disability insurance, preventative health programs, medical screenings, free or reduced-cost vaccinations, discounts on Pfizer products, mental health support, nutrition and fitness counseling and more.
• Strengthening Colleagues’ Financial Security by providing company contributions to retirement plans, life insurance and financial planning education to help colleagues achieve their financial goals.
• Providing Benefits and Time off for the Moments that Matter to ensure Pfizer colleagues have the time away from the office to recharge, recover and return to work as the best version of themselves. Vacation, Holiday time and Sick time are just the beginning, with a 12 week parental leave policy for both parents of a new born, 10 day of caregiver leave for those times when your family needs you whether it’s a child, spouse or parent, bereavement leave, and additional country-specific programs.
• And so much more, depending on your country and site, Pfizer offers childcare facilities or discount programs, on-site health and/or fitness centers , movement and mindfulness solutions, “Log in for your Day” work flexibility and so much more.
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