Global Safety Officer, I&I

BioSpace; Cambridge (MA); On-site; USD 179,000 - 298,000; Full time

Job summary

Sanofi US Services seeks an Internal & External Safety Expert to guide pharmacovigilance activities across products. You will provide PV and risk management expertise to internal and external customers, lead safety teams, and maintain knowledge of regulatory guidelines.

You will collaborate with partners and health authorities, contribute to development plans, and manage safety documentation with a focus on patient safety and data integrity.

Qualifications

• MD degree or equivalent is required.
• Board certification/eligibility preferred for MD.
• At least 3 years of international pharmacovigilance or related clinical development experience, with proven excellence considered.

Responsibilities

• Provide PV and risk management expertise to internal and external customers.
• Serve as safety expert for the product and maintain PV knowledge and regulatory understanding.
• Lead cross-functional Safety Management Teams (SMTs) and Safety Analysis Teams (SATs).
• Communicate PV positions within project teams and with Health Authorities.
• Provide proactive safety input into development plans and due diligence activities.
• Perform signal detection, assessment, and coordination of safety surveillance.

Skills

Clinical judgment

Data synthesis

Communication of complex issues

Risk assessment

Cross-functional leadership

Teamwork

English proficiency

Education

M.D. Degree or equivalent

Board Certification/Board eligible for MD

3+ years international pharmacovigilance/clinical development experience

Tools

Job description

About The Job

Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.

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.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve peoples lives. Were 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?

About Sanofi

Were an R&D-driven, AI-powered biopharma company committed to improving peoples 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 peoples lives.

Main Responsibilities

Internal & External Safety Expert

• Provide PV and risk management expertise to internal and external customers
• Safety expert for product
• Maintain knowledge of product, product environment, and recent literature
• Maintain PV expertise, and understanding of international safety regulations and guidelines
• Lead cross functional Safety Management Teams (SMTs) and GPE internal Safety Analysis Teams (SATs)
• Communicate with and represent PV position within project/product teams, with external partners, key opinion leaders, and Health Authorities, and during internal and external negotiations
• Provide strategic and proactive safety input into development plans
• Support due diligence activities and pharmacovigilance agreements

Impact

• Ongoing assessment of the safety status of the product
• Review, preparation, contribution and/or approval of clinical development documents including clinical development plans, SAPs, study protocols, investigator brochures, data monitoring plans, study reports, integrated summary of safety, summary of clinical safety, and labeling
• Review, preparation, and/or contribution to questions from health authorities, ethics committees, IRBs, external partners
• Management of product safety alerts
• Ensuring the GPE position is well articulated to and understood by its internal and external customers
• Establishment of credibility of GSO function and of GPE

Signal Detection And Assessment

• Responsible for signal detection and analysis
• Collaborate with Center of Excellence for Signal Detection and Data Mining and Safety Epidemiology group
• Identify and implement proactive safety analysis strategies to further define the safety profile.
• Lead aggregate safety data review activities and coordinate safety surveillance activities

Risk Assessment/Risk Management/ Benefit-Risk Assessment

• Provide proactive risk assessment
• Co-lead benefit-risk assessment with other relevant functions
• Develop risk management strategies and plans and monitor effectiveness
• Collaborate with Center of Excellence for Risk Management and Safety Epidemiology

Submission Activities

• Represent safety position in cross functional submission teams
• Ensure generation, consistency, and quality of safety sections in submission documents
• Write responses or contributions to health authorities questions
• Support preparation and conduct of Advisory Committee meetings

Report Writing

• Document, coordinate, review and validate Periodic reports, e.g.: RMP update, IND Annual Report, Annual Safety Report/Development Safety Update Report, Periodic Safety Update Report
• Serve as the medical safety expert to the GPE Periodic Reports group for assigned projects and products.

About You

Knowledge and Skills

• Excellent clinical judgment
• Capability to synthesize and critically analyze data from multiple sources
• Ability to communicate complex clinical issues and analysis orally and in writing
• Able to develop and document sound risk assessment
• Demonstrates initiative and capacity to work under pressure
• Demonstrates leadership within cross-functional team environment
• Excellent teamwork and interpersonal skills are required
• Fluent in English (written and spoken).

Formal Education And Experience Required

• M.D. Degree or equivalent.
• For MD, Board Certified/Board eligible, or equivalent, is preferred
• For M.D., minimum 3 years total experience in international pharmacovigilance, or equivalent relevant industry experience (e.g. clinical development) with relevant clinical experience considered. Exceptionally, candidates may be considered if they have proven excellence in a similar prior position, even if they have less than 3 years international PV experience.

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 its 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 US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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.

The Salary Range For This Position Is

$178,500.00 - $297,500.00

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.