Global Safety Officer, Vaccines

Job Title :

Global Safety Officer, Vaccines

Location :

Cambridge, MA Morristown, NJ Swiftwater, PA

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.

Major Duties and Responsibilities

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.

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 :

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)

OPTIONAL

for Lead GSO : Fosters alignment and guides

junior

GSOs in a matrix structure across an assigned portfolio.

About You

Experience :

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

Soft skills :

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

Technical skills :

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

Education :

Medical Doctor or DO preferably board-certified specialist in any therapeutic areas with at least 2 years of relevant.

Languages :

Full professional English language proficiency

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 and at least 14 weeks’ gender-neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.