Shruti Gite

Shruti Gite is a highly accomplished professional specializing in Pharmacovigilance, Drug Safety, and Medical and Scientific Writing. She holds a Postgraduate Diploma in Clinical Research and Pharmacovigilance, along with a Master’s degree in Pharmaceutics from MIT, Pune. With extensive experience as a senior drug safety expert, she has developed a deep proficiency in processing Individual Case Safety Reports (ICSRs) from spontaneous, clinical trial, and literature cases, particularly for oncological, immunological pharmaceutical drugs, and combination products.

Over the years, Shruti has mastered key aspects of drug safety operations, including case intake, booking, coding, triage, narrative writing, and aggregate reporting. Her expertise extends to CAPA, MEDRA coding, and hands-on experience with industry-standard databases such as Argus, ArisG, and Sceptre. Additionally, her experience as a Clinical Research Associate (CRA) has equipped her with a robust understanding of ICH-GCP guidelines, GDP compliance, CRF and eCRF processes, protocol assessments, Investigator Brochures (IB), and Trial Master File (TMF) reporting.

Beyond her professional endeavors, Shruti is a versatile dancer and an avid travel enthusiast, reflecting her dynamic personality and zest for life