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.
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
Monitoring of risk mitigation tool effectiveness and adjustment of strategy, as needed
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
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.
M.D. Degree REQUIRED
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