Paolo Malerba


Paolo Malerba

Associate Director, Head of the Qualified Person for Pharmacovigilance (QPPV) office

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Paolo Malerba is the head of the QPPV office, EU and UK QPPV and leads a team of EU QPPV, Local QPPVs/Local PV Officers, and Pharmacovigilance System Master File (PSMF) Specialists who deliver service associated with the QPPV role based on Good Pharmacovigilance Practices (GVPs) and local Pharmacovigilance Legislation to maintain safety oversight of new or current medicinal products available to the market for patients worldwide.

Work Experience

Paolo has been in the pharmaceutical industry for more than 20 years in different roles and 15 years in Parexel in Safety/Pharmacovigilance. His knowledge includes Pharmacovigilance, Drug Safety, Quality Assurance, Quality Control, and Production Good Manufacturing Practices (GMP) within CROs and Pharmaceutical Companies.


Paolo holds a Master’s degree in Chemistry from the University of Bari (Italy), a Post University Master’s Degree in Pharmacovigilance from Milan University (Italy), and a Master’s in Business Administration at ISTUD Business School (Milan, Italy). Paolo is based in Parexel’s UK office in Uxbridge.