Jan Kolouch

Background

About Jan Kolouch

As a seasoned Pharmacovigilance (PV) professional with a pharmacy background, I have held various senior positions and currently serve as CEO, EU QPPV, and Strategic PV Advisor. My expertise spans key areas such as EU QPPV, signal management, ICSR management, EudraVigilance and XEVMPD set-up and maintenance, PSMF development and maintenance, medical writing (PSURs, RMPs, DSURs), safety database administration, audits and inspections, and CAPA management. Throughout my career, I have significantly contributed to the development and integration of a medium-sized PV service provider into a larger organization. I pride myself on being highly focused, positive, open-minded, and detail-oriented, with a strong eagerness to learn and adapt. My approach is always to find the best solutions tailored to each client's needs. I have collaborated with colleagues and clients across multiple regions and have led teams ranging from a few members to over 250 direct and indirect reports. For any pharmacovigilance/safety related questions, feel free to reach out via info@nextpvservices.com.