Sanofi Group Global Safety Officer - MD - Cardiovascular in Cambridge (U.S.), Massachusetts

Global Safety Officer - MD - Cardiovascular


Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme.

Sanofi US

At Sanofi US, we are committed to the growth of our people, connected in purpose by career, life and health.Headquartered in Bridgewater, NJ, Sanofi US is part of a leading global healthcare company that is dedicated to improving health and driving back disease by making innovative medicines accessible to people around the world.

Our extensive research and development efforts encompass a wide range of therapeutic areas that are in line with public health issues, trends and the most pressing health needs.

Sanofi US, along with the other US affiliates, Genzyme, Sanofi Pasteur, Merial and Chattem, employs more than 17,000 people across the country.

Commitment is our Strength. Ready to grow together.

Sanofi US endeavors to make our career center accessible to any and all users. If you are experiencing difficulty and need assistance applying online, please call 1-800-207-8049 Option 7, then Option 3.

Sanofi US is an equal opportunity employer that embraces diversity to foster positive, innovative thinking that will benefit people worldwide. Sanofi US is also committed to employing qualified individuals with disabilities and, where warranted, will provide reasonable accommodation to applicants, as well as its employees.

Global Safety Officer

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


  • 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


  • Signal detection and analysis

  • Development of safety action plans and implementation, as appropriate

  • Enable effective development of product safety

  • Enable appropriate risk management

  • Enable up-to-date risk communication (e.g. labeling)

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


  • Optimization of the product benefit risk profile

  • Development of REMS, Risk Management and Development Risk Management plans

  • Identification and implementation of risk mitigation or other corrective actions as necessary

  • Regulatory compliance

  • Monitoring of risk mitigation tool effectiveness and adjustment of strategy, as needed

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


  • Review, data analysis, preparation and/or contribution, and/or update of safety sections of relevant documents:

  • For products under clinical development: Clinical Development Plan, study protocol, Statistical Analysis Plan, data monitoring plan, investigator brochure, Informed Consent Form, study report, Integrated Summary of Safety, Summary of Clinical Safety, risk management plan, label, periodic reports

  • For marketed products: Response to health authority question/request for information, Core Safety Information updates, periodic reports

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.


  • Regulatory Compliance.



  • Board Certified/Board eligible, or equivalent, is preferred

  • Minimum 3 years total experience in international pharmacovigilance, or equivalent relevant industry experience (e.g. clinical development) with relevant clinical experience considered. 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.

  • 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). #LI-SA

Job: Pharmacovigilance & Epidemiology

Primary Location: United States-Massachusetts-Cambridge (U.S.)

Job Posting: Sep 30, 2016, 9:40:58 AM

Job Type: Regular

Employee Status: Regular