Jan Petracek, MD, MSc, DIC, MIoD, FISoP, is the Executive Chairman and Co-Founder of iVigee and has gained international recognition with over 20 years of expertise in pharmacovigilance and drug safety. Dr. Petracek has been instrumental in providing guidance to many of the world’s leading biotech organizations and is often called upon when big decisions need to be made.
Prior to forming iVigee, Dr. Petracek was the co-founder and CEO of PharmInvent, a specialized pharmacovigilance and regulatory service consultancy which provided services to biotech and small-mid sized pharmaceutical organizations worldwide. While at PharmInvent, Dr. Petracek was the lead advisor and EU QPPV for multiple clients. In these roles, he was performing complex audits, strategic consulting sessions, and responsible for the outcomes of regulatory inspections. When PharmInvent was aquired in 2016, Dr. Petracek continued to lead PrimeVigilance/Ergomed as CEO until 2019.
In addition to his duties at PharmInvent and PrimeVigilance, Dr. Petracek also became an elected member of the Advisory Board for ISOP – the International Society of Pharmacovigilance. He is an active trainer of new developing pharmacovigilance professionals all over the world, and his training sessions with organizations such as DIA among others have seen him train well over 4,000 individuals in the past 15 years.
Before Dr. Petracek joined the private sector, he spent many years as the former Head of Risk Management Section at the European Medicines Agency, Head of Pharmacovigilance in the Czech Republic, Head of Strategy and Development of the Czech National Authority, CHMP Pharmacovigilance Working Party member.
Dr. Petracek’s public service has allowed him to take part in the development of National, European, ICH and CIOMS guidelines. One of his most notable highlights are his contributions to the EMA Guidline on Safety and Efficacy Follow-up Risk Management of Advanced Therapy medicinal products. The visionary guidelines he helped create are still highly effective even after 13 years as they predict future safety issues and suggest lasting solutions.
Qualified as a physician from Charles University in Prague, Dr. Petracek also holds a Master of Science with Distinction in Quality and Safety in Healthcare from Imperial College London.