Karen Cheng is a physician by training. She joined the industry with 10 years clinical experience in Emergency Medicine, Trauma, Surgery and Transfusion Medicine in the National Health Service in the UK, working in a phase I/II unit in a Biotech startup and then moving to Global Pharmacovigilance, working at AstraZeneca and Boehringer Ingelheim and is currently Senior Safety Science Director at Fishawack Archimed. She has extensive experience as the pharmacovigilance and cross functional safety management team lead for products at all stages of the clinical development and post-marketing lifecycle, including products with high profile safety concerns. In addition, she has experience of submissions both within the industry and as a Clinical Assessor at the MHRA. Karen is a fellow of the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom and has contributed extensively to the last 2 curriculum reviews of Pharmaceutical Medicine Speciality Training.