Sanofi Group Global Safety Officer in Bridgewater, New Jersey
The GSO is the safety expert and safety lead for Sanofi CHC products.
Provide PV and risk management expertise to internal and external customers.
As safety expert for products assures their ongoing safety profile assessment.
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 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.
Provide strategic and proactive safety input into development plans.
Support due diligence activities on product safety for acquisition and divestment and pharmacovigilance agreements.
Review, prepare, contribute and/or approve 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 labelling Review, prepare, and/or contribute to questions from health authorities, ethics committees, IRBs, external partners.
Manage product safety alerts.
For GSO appointed to lead RX (prescription) to OTC switch: lead the safety strategy of the switch, assess suitability of molecule for switch, prepare assessment report to support the switch.
Key Working Relationships:
Signal Detection and Assessment:
Responsible for signal detection and analysis.
Identify and implement proactive safety analysis strategies to further define the safety profile.
Lead aggregate safety data review activities and coordinate safety surveillance activities.
Enable appropriate risk management.
Enable up-to-date risk communication (e.g. labeling).
Risk Assessment/Risk Management/ Benefit-Risk Assessment:
Provide proactive risk assessment.
Develop REMS, Risk Management and Development Risk Management plans, corresponding risk management strategies, safety action plans, their implementation and monitoring of effectiveness, as appropriate.
Co-lead benefit-risk assessment with other relevant functions optimizing product benefit risk profile.
Represent safety position in cross functional submission teams ensuring generation, consistency, and quality 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.
Write responses or contributions to health authorities’ questions.
Support preparation and conduct of Advisory Committee meetings.
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.
M.D. Degree, or degree in pharmacy, biological sciences or related disciplines.
For MD, Board Certified/Board eligible, or equivalent, is preferred; For other degrees, advanced post-graduate qualifications e.g. Master or PhD are preferred.
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.
Knowledge and 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 cross-functional team environment.
Capable to bring and contribute to innovation.
Takes consumer perspective into account.
Excellent teamwork and interpersonal skills are required.
Fluent in English (written and spoken).
Experience with switches from Rx to OTC is desirable.
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.
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.