Janine Collins, MBBS, LLM

Janine Collins, MBBS, LLM

Senior Director, European Risk Management

Janine Collins serves as Senior Director, European Risk Management. In this role, Dr. Collins provides leadership, direction, and guidance for all EU risk management activities.

Following 16 years of clinical practice in Family Medicine, Dr. Collins earned more than 13 years of industry experience, predominantly in drug safety and risk management at Novartis, Abbott, and Celgene. Her drug safety experience includes safety surveillance across a broad range of therapeutic areas including oncology, neurology, cardiology, endocrinology, HIV, and rheumatology. She has also worked in Medical Affairs and Clinical Research in the medical device industry with specific experience in interventional pulmonology and the management of emphysema.

She has specific expertise in the development of European risk management plans, the implementation of risk minimization activities, and strategic support in these areas during the periapproval period. During her career, she worked on risk management plans at a time when these concepts were evolving in Europe. She has written numerous risk management plans, risk minimization programmes and post-authorisation safety study (PASS) protocols. Dr. Collins also consulted extensively with regulators in relation to the design, set up, and implementation of mandated post-authorization safety studies. Notably she designed and project managed a pan-European mandated PASS study which was acknowledged publically by an EU Regulator as being a “gold standard” for PASS protocol design and implementation.

Dr. Collins is a graduate of St. George’s Hospital Medical School in London and obtained a master’s degree in legal and ethical practice of medicine from Cardiff Law School.