Viola Macolic Sarinic

Viola Macolic Sarinic is a medical doctor specializing in clinical pharmacology, with a PhD in Pharmacogenomics applied to Biosciences and a master’s degree in clinical pharmacology (pharmacokinetics). With over 20 years of experience, she has held various roles in clinical pharmacology and pharmacovigilance. Viola has worked in university hospitals and the Croatian medicines regulatory authority, HALMED, serving as a clinical and pharmacovigilance assessor, Head of the pharmacovigilance department, national PRAC and CHMP member, and director of HALMED, overseeing its integration into the EU medicines network upon Croatia's accession to the European Union.

Following her tenure at HALMED, Viola spent two years as a national expert on secondment at the European Medicines Agency (EMA) in London, primarily in the scientific advice office. She then joined the World Health Organization (WHO) headquarters in Geneva, Switzerland, where she contributed to strengthening pharmacovigilance activities within the regulatory systems of low and middle-income countries (LMICs).

Returning to the EMA in 2019, now based in Amsterdam, Viola serves as the PRAC Scientific Committee Lead and Scientific Adviser on the safety of medicines in the Pharmacovigilance office. Her extensive expertise spans clinical pharmacology, pharmacovigilance, and regulatory affairs, making her a valuable asset in ensuring the safety and efficacy of medicines.