Fergus Sweeney is Head of Inspections and Human Medicines Pharmacovigilance Division at the European Medicines Agency. The Division is responsible for pharmacovigilance, including signal detection and management and monitoring of products on the market, and provides leadership for the Agency’s pharmacovigilance system. It ensures the coordination of inspections and good practice standards. It deals with incident management in the area of safety and quality of human medicines, in liaison with the European medicines regulatory network. The division maintains close contact with international partners in the areas of inspection and pharmacovigilance in conjunction with the Agency’s International Affairs function.