E-mail: paulo.goncalves@wum.edu.pl
Orcid: 0009-0004-2095-7309
Education
Doctoral Candidate, Medical University of Warsaw (ongoing), Master of Science in Drugs and Medicines, University of São Paulo, 2019, Bachelor of Pharmacy (Pharmacist), Pontifical Catholic University of Campinas, 2015
Employment
Senior Study Operations Associate – Clinical Research, Pfizer, Warsaw (2025–Present), supporting non‑interventional studies and cross-functional project execution.
Safety Data Management Specialist – Pharmacovigilance, Pfizer, Warsaw (2024–present), responsible for case processing, regulatory reporting, and safety data quality.
TMF Specialist – Clinical Research, ICON plc, Warsaw (2022–2024), managing clinical trial documentation and ensuring compliance with regulatory standards.
Previously held roles in analytical development and validation in pharmaceutical industry (Aché Laboratories, Anovis, Catalent Pharma), focusing on GMP/GLP compliance and method validation.
Research interests
Pharmacovigilance and drug safety in special populations, particularly lactating women.
Inclusion of pregnant and breastfeeding women in clinical research.
Clinical safety evaluation, regulatory science, and real‑world data.
Scholarships, Awards, Professional Memberships, and Academic Activities
Recipient of a PROUNI (Programa Universidade para Todos) scholarship during Pharmacy studies at the Pontifical Catholic University of Campinas (PUC‑Campinas).
Awarded a short-term research scholarship from the São Paulo Research Foundation (FAPESP) in UNICAMP/CNPQBA, supporting research activities in the field of phytochemistry.
Recipient of a CNPq (National Council for Scientific and Technological Development) fellowship during the Master’s degree in Drugs and Medicines at the University of São Paulo.
Currently attending doctoral school at the Medical University of Warsaw and actively collaborating on scientific publications related to pharmacovigilance and clinical research.
Certified in clinical trials, pharmacovigilance, and regulatory compliance, including ICH GCP and safety monitoring training.
Publications
In preparation (co‑authorship in ongoing scientific articles)