The European Medicines Agency (EMA) has appointed Merck Serono's Enrica Alteri as its new head of safety and efficacy of medicines.
In her new position she will play a leading role in the application of the EMA's new pharmacovigilance legislation, which introduces new rules governing the monitoring, identification and assessment of adverse events caused by drugs.
Dr Alteri was most recently head of risk management and epidemiology at Merck Serono's soon to be closed Swiss headquarters in Geneva, and takes over from Francesco Pignatti, the EMA's head of oncology.
Pignatti had been acting head of safety and efficacy of medicines since March, 2012, following the departure of Xavier Luria.
Dr Alteri has many years of experience in drug safety having served as director of pharmacovigilance at Serono, before its acquisition by Merck KGaA.
She has also spent time working in medical safety teams at both Novartis and Ciba, and was involved in developing the safety profiles of such products as Coartem/Riamet, which is the World Health Organization's (WHO) recommended first-line treatment against malaria.
She has also previously served as a member of the European Course of Pharmaceutical Medicine faculty (ECPM) in Basel, Swtizerland, and was part of the Council for International Organizations of Medical Sciences (CIOMS) working group on pharmacovigilance in resource-poor countries.