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
His professional background combines expertise in pharmacovigilance, clinical research, and pharmaceutical quality. He currently works as a Senior Manager in International Patient Safety at Bristol Myers Squibb (BMS), contributing to global drug safety activities and safety operations. Previously, he worked at Pfizer in Warsaw as a Senior Study Operations Associate in Clinical Research, supporting the implementation of non-interventional studies and cross-functional project management, and as a Safety Data Management Specialist in Pharmacovigilance, where he was responsible for case processing, regulatory reporting, and safety data quality management. He also gained clinical research experience at ICON plc as a Trial Master File Specialist, focusing on clinical trial documentation and compliance with regulatory requirements. Earlier in his career, he worked in the pharmaceutical industry at Aché Laboratories, Anovis, and Catalent Pharma, with a focus on analytical development, method validation, and compliance with GMP and GLP standards.
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)