Mahesh Sirasangi

Pharmacovigilance Services Analyst @Accenture

Bengaluru, IN

Effectively executed and managed end-to-end ICSR case processing for spontaneous, solicited, and clinical trial cases, ensuring 100% compliance with GVP Module VI and global regulatory timelines.Independently conducted causality assessments using WHO-UMC and Naranjo Algorithm, determining the relationship between drug exposure and reported adverse events.Led seriousness and expectedness/listedness assessments, ensuring regulatory compliance for both clinical trial and post-marketing casesDemonstrated expertise in case narrative writing, ensuring high-quality, well-structured narratives in compliance with ICSR reporting requirements and regulatory expectations.Processed and evaluated non-clinical events, including off-label use, lack of efficacy, medication errors, overdose, drug misuse, and abuse cases, ensuring proper classification and risk assessment.Assessed and managed pregnancy and lactation cases, including prospective and retrospective pregnancy reports, ensuring appropriate follow-ups for maternal and fetal outcomes in accordance with regulatory guidelines.Experienced in analyzing and interpreting discharge summaries and medical records to extract relevant adverse events (AEs), concomitant medications (ConMeds), and historical conditions for accurate ICSR case processing.Reviewed and validated Robotic Process Automation (RPA) outputs, ensuring automation accuracy and eliminating manual inefficiencies in ICSR processing.

JSS College of Pharmacy - India

Master's degree, M.PHARM. pharmacology

JSS College of Pharmacy - India

Postgraduate diploma in clinical practice and research

KLE College of Pharmacy, Hubli

Bachelor's degree, B.PHARM. pharmaceutical sciences