Nicole Baker
PhD
Nicole Baker is an experienced life sciences professional with broad knowledge in global legislation and guidelines for Medical Affairs, Regulatory Affairs, Pharmacovigilance and Clinical Trials, gained by leading and managing global, multi-disciplinary teams.
She has extensive experience preparing submissions for global Marketing Authorisation Applications, and providing strategic, operational and scientific leadership throughout the product life-cycle, from pre-clinical to post-marketing.
She has extensive experience in setting up, implementing and managing processes for Clinical and Pharmacovigilance Systems, including automation and the use of Artificial Intelligence.
Over the past 7 years’ she has gained experience supporting or fulfilling the role of European Economic Area Quality Person for Pharmacovigilance. Overall 20 years’ experience gained within Academia, Pharmaceutical Industry, Regulatory Authority and Clinical Research Organisation.
She has been involved in several teaching programs and scientific projects, including pre-clinical, clinical, post-marketing and innovative translational research, which has been published in high impact peer reviewed journals. She is an active and keen member of Pharmacovigilance network, actively contributing with talks and presentations.
She holds a Professional Diploma in Strategic Growth/Biotech and Pharma Industry from University College Dublin, a PhD in Medicine/Rheumatology from University College London, a MSc in Biomedical Sciences/Immunology from Universidade Sao Paulo, and a BSc in Biological Sciences from Universidade Ibirapuera.