Francesca Kolitsopoulos

About Francesca Kolitsopoulos

Pharmacoepidemiologist and RWE Executive with extensive strategic and hands-on experience leveraging global observational and real-world evidence (RWE) solutions and deep knowledge of integrated evidence planning, post authorization safety studies, and health disparity research with academic collaborators. Oversee team of epidemiologists that provide global epidemiologic solutions for Pfizer\'s robust oncology portfolio. With over 24 years as an industry scientist, implemented large pragmatic trials/ low intervention studies, external research collaborations, clinical trials, and non-interventional (NI) studies with global teams. Business Process Lead for Observational/NI Study Standard Operating Procedures (SOPs) that ensure compliance and appropriate framework for robust, scientific, regulatory-grade solutions that enhance RWE applicability and acceptance in filings. Experiencing firsthand challenges associated with social determinants of health and health illiteracy, strive to design RWE studies that weave health disparity research with the hope of creating tangible change in health equity.Specialties: Regulatory-Grade RWE Strategies | Integrated Evidence Plan | Post Authorization Safety Studies | Non-Interventional Studies | Global Studies | Study Methodology | Large Pragmatic Trials | Compliance, Safety, and Auditing

Experience

1. Senior Director, Rwe Pharmacoepidemiology and Safety Head (Oncology)

   Gilead Sciences

   Mar 2024 — Present · Parsippany, NJ, US

Education

• Columbia University

  MPH

• Quinnipiac University

  BS