Global Safety Officer - I&I
$178.5k - $297.5k
Mid, Senior
MD
Cambridge, MA, USA+1 moreMore locations: Morristown, NJ, USA
Hybrid
Biology & BiotechRegulatory & Quality (Life Sciences)
About the job
Requirements
- Demonstrate excellent clinical judgment.
- Synthesize and critically analyze data from multiple sources.
- Communicate complex clinical issues and analysis orally and in writing.
- Develop and document sound risk assessments.
- Demonstrate initiative and the capacity to work under pressure.
- Demonstrate leadership within a cross-functional team environment.
- Demonstrate teamwork and interpersonal skills.
- Be fluent in written and spoken English.
- Hold an M.D. degree or equivalent.
- For M.D. candidates, have a minimum of 3 years of total experience in international pharmacovigilance, or equivalent relevant industry experience such as clinical development, with relevant clinical experience considered. Candidates with proven excellence in a similar prior position may be considered exceptionally with less than 3 years of international pharmacovigilance experience.
Responsibilities
- Provide pharmacovigilance and risk management expertise to internal and external customers.
- Serve as the safety expert for assigned products.
- Maintain knowledge of products, their environments, and recent literature.
- Maintain pharmacovigilance expertise and understanding of international safety regulations and guidelines.
- Lead cross-functional Safety Management Teams and internal Safety Analysis Teams.
- Communicate and represent the pharmacovigilance position within project and product teams, with external partners and key opinion leaders, and before health authorities and during internal and external negotiations.
- Provide strategic and proactive safety input into development plans.
- Support due diligence activities and pharmacovigilance agreements.
- Continuously assess the safety status of assigned products.
- Review, prepare, contribute to, and/or approve clinical development documents, including clinical development plans, statistical analysis plans, study protocols, investigator brochures, data monitoring plans, study reports, integrated summaries of safety, summaries of clinical safety, and labeling.
- Review, prepare, and/or contribute to responses to questions from health authorities, ethics committees, institutional review boards, and external partners.
- Manage product safety alerts.
- Ensure the Global Patient Safety position is clearly articulated to and understood by internal and external customers.
- Establish the credibility of the Global Safety Officer function and Global Patient Safety.
- Conduct signal detection and analysis.
- Collaborate with the Center of Excellence for Signal Detection and Data Mining and the 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.
- Provide proactive risk assessments.
- Co-lead benefit-risk assessments with relevant functions.
- Develop risk management strategies and plans, and monitor their effectiveness.
- Collaborate with the Center of Excellence for Risk Management and Safety Epidemiology.
- Represent the safety position in cross-functional submission teams.
- Ensure the generation, consistency, and quality of safety sections in submission documents.
- Write or contribute to responses to health authority questions.
- Support the preparation and conduct of Advisory Committee meetings.
- Document, coordinate, review, and validate periodic reports, including Risk Management Plan updates, Investigational New Drug annual reports, Annual Safety Reports/Development Safety Update Reports, and Periodic Safety Update Reports.
- Serve as the medical safety expert for the Global Patient Safety Periodic Reports group for assigned projects and products.
Desired Qualifications
- For M.D. candidates, be board-certified or board-eligible, or equivalent.
About the company
Sanofi is a global pharmaceutical and biotechnology company that develops, manufactures, and sells prescription medicines, over-the-counter products, and vaccines. Its products span immunology, oncology, rare diseases, and vaccines, addressing unmet medical needs through a strong focus on research and development. Sanofi's core product model relies on large-scale R&D, strategic partnerships, and licensing to bring new therapies to markets, with revenue generated from product sales and collaborations. The company differentiates itself by leveraging its global reach, diverse portfolio, and emphasis on patient-centric solutions, safety, and quality to navigate regulatory environments in developed and emerging markets. The company’s goal is to improve health outcomes and quality of life for people worldwide by delivering innovative treatments and vaccines that meet unmet medical needs.
Company Size
10,001+
Company Stage
IPO
Headquarters
Paris, France
Founded
1973
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Simplify's Take
What believers are saying
- July 10, 2026 FDA approval of Sarclisa Escena created the first on-body cancer injector.
- June 13, 2026 FDA accelerated approval expanded Tzield into recently diagnosed stage 3 T1D.
- Q2 2026 sales grew 17.8% at CER, with Dupixent and Beyfortus leading.
What critics are saying
- Texas sued Sanofi on February 19, 2026 over provider bribery and Medicaid fraud.
- Sanofi sued Pfizer and Moderna on July 15, 2026, extending costly mRNA patent warfare.
- Dupixent concentration makes 2030s patent loss an existential revenue shock.
What makes Sanofi unique
- Dupixent reached €5.2 billion quarterly sales in Q2 2026 across nine indications.
- October 1, 2026, Sanofi and Regeneron added four long-acting antibodies to their Alliance.
- Sanofi's 61-project pipeline spans immunology, rare diseases, vaccines, neurology, and oncology.
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Benefits
- Health Insurance
- Professional Development Budget
- Parental Leave