Global Safety Officer M/F
Bridgewater, New Jersey
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Global Safety Officer
About the opportunity
Sanofi Genzyme is looking for a Global Safety Officer in the field of Rare Diseases.
In this role, you provide medical input on the safety evaluation of established drugs and drugs under development. This will contribute to innovative new therapies in Rare Diseases which will directly improve the life of patients.
About Sanofi Genzyme
Sanofi Genzyme is the specialty care global business unit of Sanofi, focused on rare diseases, multiple sclerosis, oncology, immunology and rare blood disorders. We help people with debilitating and complex conditions that are often difficult to diagnose and treat. We are dedicated to discovering and advancing new therapies, providing hope to patients and their families around the world.
Our ambition is to be the industry leader in specialty care. We currently provide more than 20 treatments to patients globally, with many potential new therapies being studied in clinical trials and in Sanofi laboratories.
About growing with us
In this role you will be active in five main areas:
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
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
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
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
Qualifications/Education & work experience
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
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)
Inspire your Journey, what Sanofi can offer you
An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team
You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully
As a globally successful and constantly growing company, Sanofi provides international career paths as well
This is our Sanofi, Discover yours.
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As part of its diversity commitment, Sanofi is welcoming and integrating people with disabilities.
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