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Head of Inspections, Human Medicines Pharmacovigilance and Committees

European Medicines Agency

Current Responsibilities

Fergus Sweeney is Head of Inspections, Human Medicines Pharmacovigilance and Committees Division at the European Medicines Agency. The Division provides the organisational and operational support to the Agency’s Human Scientific Committees in close collaboration with the elected chairs and nominated members. It is responsible for pharmacovigilance and epidemiology, including signal detection and management, monitoring of products on the market and providing leadership for the Agency’s pharmacovigilance system. It ensures the coordination of inspections and good practice standards, coordinates incident management in the area of safety and quality of human medicines in liaison with the European medicines regulatory network and maintains close contact with international partners in the areas of inspection and pharmacovigilance in conjunction with the Agency’s International Affairs function. The Division oversees the work of the EU NTC Training platform, whose mission is to ensure good scientific and regulatory practice is spread across the European medicines regulatory network.

Brief Employment History

Fergus joined the Agency in 1999 in the Inspection Sector and was appointed Head of Sector, Compliance and Inspections in May 2009. In August 2013 he was appointed Head of Division Inspections and Human Medicines Pharmacovigilance which became the Inspections, Human Medicines Pharmacovigilance and Committees Division in 2016.

Fergus has a Degree in Physiology (Trinity College Dublin, Ireland, 1979), a Doctorat de Troisiéme Cycle in cancer biology (Université de Paris, 1982), and a PhD in Pharmacology (UCD, Ireland, 1986). Prior to joining the Agency he worked in industry from 1982 to 1999, covering phase I-IV clinical research, pharmacovigilance and laboratory activities, primarily in the field of quality assurance.