Sophie Gaillard, M.D.
About Sophie Gaillard, M.D.
Sophie Gaillard, M.D. serves as the Senior Director of Safety and Pharmacovigilance at Insmed Incorporated, bringing over 30 years of international experience in drug safety and clinical research. Her extensive background includes roles at various pharmaceutical companies, focusing on the safety profiles of products related to serious and rare diseases.
Work at Insmed
Sophie Gaillard, M.D. serves as the EU QPPV Senior Director of Safety and Pharmacovigilance at Insmed Incorporated since 2020. In this role, she is responsible for the oversight and continuous monitoring of the safety profiles of Insmed products, particularly those related to serious and rare diseases, in the EMEA region. Her extensive experience in drug safety and pharmacovigilance supports her leadership in ensuring compliance with regulatory requirements and maintaining patient safety.
Previous Experience in Pharmacovigilance
Prior to her current position, Sophie Gaillard worked at several pharmaceutical companies, including Horizon Pharma plc and Raptor Pharmaceuticals. At Horizon Pharma, she held the role of Global Drug Safety Physician and EU QPPV, where she was responsible for local pharmacovigilance in France from 2016 to 2018. At Raptor Pharmaceuticals, she served as EU QPPV Deputy and Global Pharmacovigilance & Drug Safety from 2014 to 2016. Her roles involved ensuring drug safety compliance and monitoring adverse events.
Clinical Research and Development Background
Sophie Gaillard has a robust background in clinical research and development, having worked in various capacities at ConvaTec and GUERBET. Her roles included Clinical Research Associate, Head of Medical Department, and Head of Clinical Development. She also served as Head of Pharmacovigilance and EU QPPV at GUERBET from 2008 to 2012. This diverse experience has equipped her with a comprehensive understanding of both clinical and post-marketing phases of drug development.
Education and Expertise
Sophie Gaillard holds a Medical Doctor (MD) degree from Université Paris 13, which she completed from 1977 to 1987. She also has a National Diploma in Nursing studies from Université Paris 13 and various certifications in pharmacovigilance and medical statistics. Her education includes training in Clinical Trials Methodology and Excellence in Pharmacovigilance, enhancing her expertise in drug safety and clinical research.
Therapeutic Experience
Sophie Gaillard possesses extensive therapeutic experience across a variety of medical fields. Her work encompasses rare diseases, oncology, cardiology, neurology, respiratory conditions, infectious diseases, inflammatory and degenerative diseases, dermatology, wound healing, emergency medicine, and intensive care. This broad therapeutic knowledge supports her role in pharmacovigilance and drug safety, allowing her to address the complexities of various medical conditions.