Position title: Project Leader, Pharmacovigilance

Department: PSPV Regional Safety Americas

Location: Toronto, ON (Hybrid)

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

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.

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