The Global Safety Officer is responsible for global pharmacovigilance (PV) for marketed and/or investigational products, including review and analysis of safety data from post-marketing sources and from clinical trials, the identification and investigation of safety signals, management of benefit-risk profile for assigned compounds and products. Responsible for keeping upper management informed of safety issues and may work with clinical programs as medical advisor. May represent Bioverativ, a Sanofi Company, Drug Safety and Risk Management at internal and external meetings. May be appointed as the Global Safety Officer for a specific compound / product.
The successful candidate will demonstrate the flexibility and capability to function at a high level across multiple disease areas and will be comfortable working in an entrepreneurial environment to advance the safety and biological understanding of compounds through life cycle. The individual who assumes this position will interact with multiple levels of management within Bioverativ, a Sanofi Company, external stakeholders in the medical community as well with global regulatory authorities.
· Manage safety surveillance for assigned compounds / products
· Manage collection, in cooperation with a PV scientist, of current data for safety signaling and identify and investigate safety signals.
· Conduct analysis of safety data.
· Ensure adequacy of recording, summarizing, and handling of adverse events for investigational and/or marketed Bioverativ, a Sanofi Company, products including decisions on seriousness, expectedness, and causality.
· Provide safety strategic leadership for clinical development programs / program teams
· Integrate the safety scientific component to build a strategic framework for clinical development plans.
· Develop and maintain relationships with program counterparts in Clinical Development, Pre-Clinical Safety, Research, Regulatory, Clinical Operations, Clinical Pharmacology, Quantitative Sciences, Translational Sciences, Worldwide Medical.
· Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal timeframes and timeframes dictated by regulatory authorities.
· If applicable, manage Medical Director(s) and Associate Medical Director(s) overseeing their activities for assigned compounds / products.
· Minimum 5 years' experience in the pharmaceutical industry or clinical care setting.
· MD, MD/PhD, or MD/MPH degree(s) required
· Experience in clinical development or drug safety is preferred
· Sub-specialty training is highly desirable
· Knowledge of pre- and post-marketing US and EU regulations
· Knowledge of clinical pharmacology highly desirable.
· Demonstrated strategic and critical thinking.
· Excellent communication skills (oral and written) and excellent organizational skills.
· Capacity and willingness to work effectively across disease areas.
· The ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills.
· Demonstrated sense of urgency and accountability for both individual and team-owned work products.
· Demonstrated ability to work in an entrepreneurial culture
The successful candidate will be required to sign and execute a restricted covenant upon hire.
Sanofi US Services, 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.