What are the responsibilities and job description for the Global Safety Officer immunology Inflammation position at ASB Resources?
About the Job
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
An exciting opportunity to join a dynamic therapeutic area in Sanofi!
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)
Communicate with and represent PV analyses and PV position within project / product teams in safety governance and benefitrisk governance activities and committees (e.g. Safety Management Committee BenefitRisk Assessment Committee) 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 & Assessment
Responsible for signal detection and analysis
Collaborate with Center of Excellence for Signal Detection 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
Colead benefitrisk assessment with other relevant functions
Develop risk management strategies and plans and monitor effectiveness
Collaborate with Center of Excellence for Risk Management and Epidemiology / BenefitRisk groups
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 contribute to coordinate review and / or 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 GPV Periodic Reports group for assigned projects and products
About you
Knowledge & 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 crossfunctional team environment
Excellent teamwork and interpersonal skills are required
Fluent in English (written and spoken)
Formal Education & Experience Required
M.D. Degree
For MD Board Certified / Board eligible or equivalent is preferred
For M.D. minimum 3 years and for other degrees minimum 5 years experience in PV
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