About the role
Reference no. R2860572
Position title: Project Leader, Pharmacovigilance
Department: PSPV Regional Safety Americas
Location: Toronto, ON (Hybrid)
About Sanofi
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.
About the job
Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.
Contribute to establishing the benefit-risk profile of Sanofi Canada products in close collaboration with corporate and local teams, while maintaining compliance with Corporate and Canadian requirements.
This position is responsible for leading activities in one or more of the following areas: management of PV requirements in patient programs and commercial projects, PV process optimization, local safety surveillance, quality assurance activities, participation in audits/inspections, local PV vendor oversight, Canadian and foreign case handling activities, risk management, quality system, training, compliance, PV systems, safety data exchange agreements, monitoring of emerging Canadian PV regulatory requirements, crisis management, medical safety management of local products.
The PV Project Leader partners strategically with internal cross-functional teams by providing PV expertise and building close and robust relations with the in-country partner functions, including but not limited to Medical, Regulatory, Quality, Commercial, Legal, and procurement.
Main responsibilities:
Contribute to the PV activities for Sanofi Canada.
Ensure compliance for PV requirements for patient programs and other commercial projects, including vendor oversight.
Responsible for quality assurance activities for the local PV vendor.
Contribute to the processing of domestic individual case safety reports (ICSRs) according to Corporate and Canadian requirements.
Contribute to the evaluation of domestic and foreign ICSRs for submission to Health Canada.
Handle safety related queries including crisis situations, and urgent Health Canada requests.
Partner strategically with internal teams.
Administer PV training programs to internal staff and external vendors.
Participate in compliance monitoring.
Organize and complete local safety surveillance activities.
Coordinate preparation, and submission of periodic safety update reports.
Develop local risk management strategies in close partnership with the Canada Risk Management Lead, global and local teams, and in accordance with Canadian requirements.
Organize a local quality system (SOPs) supporting PV activities.
Manage safety data exchange agreements.
Perform medical safety management of local products.
About You
Key requirements for this job:
Education
Pharmacy or Medical Degree: B. Pharm., B.Sc. Pharm., Pharm. D, MD. ; or license to practice medicine or pharmacy (Registered nurse with University degree or University degree in science and relevant experience and competency profile may be considered).
Experience
+2 years experience in the pharmaceutical industry or in a relevant Pharmacovigilance setting. Other relevant experience in a Health Care setting may also be considered.
Specific skills and/or competencies
Action-oriented, able to work with constant short deadlines
Able to manage projects
Skilled with computer applications
Strong communication skills
Excellent analytical and problem-solving abilities
Excellent interpersonal skills
Strong organization and priority setting skills
Ability to focus on details where relevant whilst considering the global picture
Resourceful and able to take ownership of areas of responsibility
Languages
English, written and spoken
French an asset
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs.
Applications received after the official close date will be reviewed on an individual basis.
This position is for a new vacant role that is now open for applications.
AI Usage
"Artificial Intelligence” refers to any systems that use automated processes, including algorithms and machine learning, to analyze data and make predictions, inferences, decisions, or recommendations without direct human involvement. These systems may process personal information to identify patterns, improve services, or support decision-making. The Company may use Artificial Intelligence for purposes including, but not limited to, resume screening and hiring, scheduling interviews or meetings, conducting surveys, matching skills with potential job openings, interview scoring, ensuring compliance with regulations applicable to our industry, and activities related to performance evaluation. Information collected and processed by the Company’s Artificial Intelligence systems may include the personal information detailed above and calendar availability. It excludes the information collected and processed for monitoring purposes. You should contact Human Resources if you have a question or concern regarding your personal information. You can also contact Canada’s Privacy Officer via Sanofi’s data subject request portal, Data Subject Rights Webform. The Data Subject Rights Webform can also be used to request access or correction of your personal information and file a complaint.
Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request.
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Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
North America Applicants Only
The salary range for this position is:
127,000.00 - 177,000.00 (Includes target bonus)Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefits programs, and additional benefits information can be found through the (CA)LINKOR (US) LINK.
La fourchette salariale pour ce poste est la suivante:
127,000.00 - 177,000.00 (Comprend le bonus cible)La rémunération finale sera déterminée en fonction de l'expérience démontrée, des compétences, du lieu de travail et d'autres facteurs pertinents. Les employés peuvent être admissibles à participer aux programmes d'avantages sociaux de l'entreprise, et des informations supplémentaires sur les avantages sociaux peuvent être trouvées via le lien
Aplyr's read
Sanofi is a leading global healthcare company specializing in therapeutic solutions for complex diseases, attracting professionals passionate about innovation in human health.
What's promising
- •Sanofi has a strong focus on innovative therapies for diabetes, oncology, and rare diseases.
- •The company invests heavily in research and development, ensuring a robust pipeline of new treatments.
- •Sanofi's global presence offers diverse career opportunities in various healthcare sectors.
What to watch
- •The pharmaceutical industry faces intense regulatory scrutiny, which can impact Sanofi's operations.
- •Sanofi's competitive market requires constant innovation to maintain its leadership position.
- •Global operations may lead to complexities in supply chain and regulatory compliance.
Why Sanofi
- •Sanofi's emphasis on rare diseases sets it apart in the pharmaceutical industry.
- •The company has a dedicated focus on immunology, offering specialized career paths.
- •Sanofi's commitment to global health solutions differentiates it from competitors.
Aplyr’s read is generated by AI from public sources. Was it useful?
About Sanofi
Sanofi is a global healthcare company focused on human health. It develops and provides therapeutic solutions in areas such as diabetes, oncology, immunology, and rare diseases.
