Global Safety Officer

Job description

Major Duties and Responsibilities

Internal & External Safety Expert:

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Provide PV and risk management expertise to internal and external customers

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Safety expert for product

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Maintain knowledge of product, product environment, and recent literature

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Maintain PV expertise, and understanding of international safety regulations and guidelines  

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Lead cross functional Safety Management Teams (SMTs)

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Communicate with and represent PV analyses and PV position within project/product teams, in safety governance and benefit-risk governance activities and committees (e.g. Safety Management Committee, Benefit-Risk Assessment Committee), with external partners, key opinion leaders, and Health Authorities, and during internal and external negotiations

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Provide strategic and proactive safety input into development plans •   Support due diligence activities and pharmacovigilance agreements 

Signal Detection and Assessment:

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Responsible for signal detection and analysis

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Collaborate with Center of Excellence for Signal Detection and Data Mining and Safety Epidemiology group

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Identify and implement proactive safety analysis strategies to further define the safety profile.

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Lead aggregate safety data review activities and coordinate safety surveillance activities 

Risk Assessment/Risk Management/ Benefit-Risk Assessment:

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Provide proactive risk assessment

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Co-lead benefit-risk assessment with other relevant functions

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Develop risk management strategies and plans and monitor effectiveness

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Collaborate with Center of Excellence for Risk Management and Epidemiology/Benefit-Risk groups 

Submission Activities:

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Represent safety position in cross functional submission teams  

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Ensure generation, consistency, and quality of safety sections in submission documents

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Write responses or contributions to health authorities’ questions

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Support preparation and conduct of Advisory Committee meetings 

Report Writing:

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Document, contribute to, coordinate, review and/or validate Periodic Reports, e.g.: RMP/Risk Management Plan update, IND Annual Report, Annual Safety Report/Development Safety Update Report, Periodic Safety Update Report

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Serve as the medical safety expert to the GPV Periodic Reports group for assigned projects and products

Qualifications:

Knowledge and Skills

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Excellent clinical judgment

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Capability to synthesize and critically analyze data from multiple sources supported by sound clinical reasoning

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Ability to communicate complex clinical issues and analysis orally and in writing

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Able to develop and document sound risk assessment

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Demonstrates initiative and capacity to work under pressure

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Demonstrates leadership within cross-functional team environment

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Excellent teamwork and interpersonal skills are required

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Fluency in English (written and spoken).

Formal Education And Experience Required

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M.D. Degree  

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For MD, Board Certified/Board eligible, or equivalent, is preferred; For other degrees, advanced post-graduate qualifications e.g. Master or PhD are preferred.    

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For M.D., minimum 3 years' and for other degrees, minimum 5 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. 

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.