Dr. Joan D’souza is a seasoned pharmacovigilance, clinical safety, and regulatory affairs leader with
progressive global experience across the US and Europe in clinical development (Phase I–IV) and
post-marketing safety, supporting biotech and pharmaceutical companies.
She currently serves as a Qualified Person for Pharmacovigilance (QPPV) and Regulatory Affairs
(LCPRA) in Switzerland, Germany, Austria, and Liechtenstein, and as a GVP/GCP auditor, as well as
Deputy local contact person for pharmacovigilance in the UK and Ireland liaising with regulatory
authorities including EMA, FDA, Swissmedic, BfArM, and MHRA. In these roles, she oversees
comprehensive safety surveillance and regulatory compliance across the entire product lifecycle,
from market release decision to regulatory submission.
With a rare combination of qualifications—a medical degree, licensure as a U.S. attorney, a Master’s
degree in Pharmacovigilance and Pharmacoepidemiology, and an ongoing PhD in Drug–Device
Combination Surveillance—Dr. D’souza brings a uniquely multidisciplinary perspective to drug safety
and combination products. She manages end-to-end case processing, medical review, signal
evaluation, aggregate report (DSUR, RMP, PSUR, PBRER, REMS), risk management planning, SOP
development, PSMF oversight, safety report submissions, regulatory authority liaison, and inspection
readiness.
Additionally, her leadership spans oversight of international safety teams, training curriculum
development, and strategic input on safety planning, ensuring clinical oversight and compliance
across product development through all phases of clinical trials and post-marketing activities.
As the founder of JD Pharma Services, a one-stop solution provider for pharmaceutical needs, a
Visiting lecturer for AH Akademie fur Fortbildung Heidelberg, a moderator of the Pharmacovigilance,
Regulatory Affairs, and Drug-Device Combination Working Groups at Zug Pharma Group
(Switzerland), as well as former President of the International Society of Pharmacovigilance Swiss
and Austria Chapter, Dr. D’souza remains a driving force in pharmacovigilance, regulatory oversight,
vendor management, and regulatory submissions. Fluent in English and German, she is dedicated to
advancing patient safety through operational and benefit–risk excellence and regulatory integrity.
Dr. D’souza’s therapeutic experience includes oncology, immunology, cardiology, gastroenterology,
rare diseases, endocrinology, dermatology, and neurology, among others. She remains deeply
committed to advancing patient safety and regulatory excellence in complex global environments.
Dr. Joan D’Souza
CEO
JD Pharma Services
Bridging medical, regulatory, and legal expertise to strengthen global pharmacovigilance compliance.