Pramod Gaikwad

At the TIMI Study Group at Brigham and Women’s Hospital, I review safety and efficacy event dossiers for complex global cardiovascular trials, support clinical event adjudication, and oversee patient-level safety and protocol compliance.

Previously at Merck Sharp & Dohme, I wrote ICH E3 adverse event narratives and helped align trial disclosures, safety data, publications, and evolving FDA, EMA, and ICH requirements. I also supported global clinical-trial registration and results disclosure at DOCS, a Division of ICON Clinical Research.

My clinical research experience spans study coordination at Massachusetts General Hospital and Rush University Medical Center, medical monitoring and safety reporting across more than 150 studies at Sitec Labs, and protocol, EDC, CRF, and safety-data work across Phase I–IV research.

Before focusing on research and pharmacovigilance, I provided frontline emergency, critical-care, and occupational health medicine in India and led multidisciplinary teams, remote medical units, and BLS/ACLS training programs. I bring a physician’s perspective to patient safety, scientific integrity, and data-driven clinical decision-making.