Nadia Barozzi
PhD, MAS ETH NH, PharmD, NLP Master Practitioner
RWE & RWD Strategy | Pharmacopidemiology | Clinical Research & Operations | Drug Safety | Evidence Generation | Thought Leadership
Multidisciplinary expert in evidence generation, real-world data (RWD) strategy, pharmacoepidemiology, and clinical operations with over 15 years of experience across pharmaceutical companies, CRO, and freelance settings.
I work at the intersection of science, regulation, and innovation, designing fit-for-purpose Real-World Evidence (RWE) solutions across the product lifecycle, from data feasibility and protocol design to regulatory submission and strategic communication.
Known for analytical rigor, intellectual curiosity, and cross-functional thinking, I bridge technical aspects to operation in drug development. Recognized for intellectual rigor, cross-functional fluency, and a distinctive ability to translate methodological complexity into actionable study designs, and stakeholder value.
GET TO KNOW ME
I have completing a PhD in Pharmacoepidemiology & Health Services Research, and throughout the different experiences in the pharmaceutical industry, I have built a solid scientific background in multiple therapeutic areas and strong clinical operation experience.
As a public health and pharmacoepidemiology professional, I have spearheaded the development, implementation, and monitoring of global epidemiology research projects for new product development and post-marketing surveillance. My contributions include designing epidemiology studies to investigate natural history of disease, treatment patterns, safety signals, and post-authorization safety studies (PASSs).
I have worked with diverse data sources (e.g., THIN, Nordic Registries, MDV, JMDC, HIRA, SNDS, GePaRD, disease registries), and contributed to clinical protocol design and development, review of statistical analysis plans (SAPs), and signal detection in large adverse event reporting system databases.
I have conducted data landscaping, fit-for purpose data source feasibility, literature reviews, and authored the epidemiology sections of Periodic Safety Update Reports (PSURs) for known and potential risks as defined in Risk Management Plans (RMPs). Additionally, I have authored regulatory responses, risk management and safety reports, and expert statements.
As the Scientific Data Strategist Director at a leading CRO, I have overseen a broad range of activities in the pre-award and post-award phases. My role involved planning integrated evidence generation plans and conducting hybrid studies (primary and/or secondary data collection) throughout different product life cycle stages, including early engagement (Phase II/III), pre-launch (Phase III), and post-marketing (Phase IV).
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