Project Leader, Pharmacovigilance

Reference No: R2817587

Position Title: Project Leader, Pharmacovigilance

Location: Toronto, ON

Department: PSPV Regional Safety Americas

About the job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

Position summary:

Contribute to establishing the benefit-risk profile of Sanofi group products in close collaboration with corporate and local teams, while maintaining compliance with Corporate and Canadian Pharmacovigilance 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.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• Contribute to the PV activities for the Sanofi groups in Canada, including Specialty Care, General Medicines, and vaccines.

• 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. (Registered nurse with University degree or University degree in science and relevant experience and competency profile may be considered)

Experience:

• 3 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 competenciesPharmacy or Medical Degree: B. Pharm., B.Sc. Pharm., Pharm. D, MD. (Registered nurse with University degree or University degree in science and relevant experience and competency profile may be considered)

• Action-oriented, able to work with constant short deadlines

• 3 years experience in the pharmaceutical industry or in a relevant Pharmacovigilance setting. Other relevant experience in a Health Care setting may also be considered. 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:French and English, written and spoken

Computer Knowledge: Microsoft Office

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

This position is for a current vacant role that we are actively hiring for.​

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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