Global Safety Officer
Reference No. R2719829
Position Title: Global Safety Officer
Department: Therapeutic Area Dengue, Endemics & Travelers Vaccines, Covid
Location: Toronto, Ontario
Sanofi's global vaccines business unit partners with the public health, medical and scientific communities to improve access to life-protecting vaccines and increase vaccination coverage, while striving to develop new and improved vaccines to enhance health and well-being.
At Sanofi, we chase the miracles of science to improve people’s lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.
The Patient Safety & Pharmacovigilance (PSPV) aspiration is to be a cutting-age safety group, to enable us to optimize the benefit-risk profiles of our therapies, so we can best serve patients, care givers and health care professionals.
Global Safety Officers (GSOs) are part of an international, dynamic, and culturally diverse team. Our GSOs provide medical-safety expertise based on deep knowledge of the therapeutic landscape and up to date methodologies.
The GSO is responsible for performing core pharmacovigilance activities, in partnership with GPV colleagues and cross-functional experts, to evaluate benefit-risk profiles throughout the lifecycle of a broad range of marketed products and innovative therapies in clinical development.
Leads cross-functional Safety Management Teams (SMT), PV contribution for Benefit Risk Assessment Committees (BRAC), and periodic safety reports for accuracy, completeness, quality, and timely finalization for assigned products.
Represents PV positions within Global Project Teams (GPT), Safety Management Committees (SMC) and Benefit Risk Assessment Committees (BRAC).
Contributes to continuous improvement and refinement of methodologies, processes, and to audits and inspections.
Provides safety evaluations and responses to safety inquiries from stakeholders (e.g. health authorities, business partners, etc.).
Collaborates with colleagues mainly from PSPV as well as Pre-Clinical & Clinical Development, Regulatory Affairs, Medical Affairs, Legal and Global Business Units.
Provides safety expertise, disease and patient knowledge for assigned products in terms of benefit-risk assessments, and risk management (incl. risk minimization measures.
Medical Doctor, preferably board-certified specialist in relevant therapeutic areas.
Alternatively advanced health care discipline degree (PharmD, PhD, etc.) specialized in relevant areas in the pharmaceutical industry.
Clinical experience in relevant therapeutic areas (in hospital settings is a plus).
In-depth experience of pharmacovigilance and risk management, understanding of drug development and regulatory guidelines.
Expertise in signal detection / evaluation methodologies related to drug safety information throughout the product life cycle.
Applying biostatistical and pharmacoepidemiological science in the context of pharmacovigilance.
Strong team player who is able to collaborate in a cross-functional environment.
Self–motivated, able to prioritize and plan work independently.
Good communicator with attention to detail while seeing the big picture.
Open to learn and to use digital and innovative solutions in a changing environment.
Strong analytical thinking incl. evaluation, interpretation and synthesis of scientific data.
Ability to summarize, critically discuss key findings from safety data in both internal and external discussions.
Full professional English language proficiency.
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.
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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.
Thank you in advance for your interest.
Only those candidates selected for interviews will be contacted.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.