vikas saini

About me

Detail-oriented Pharmacovigilance and Regulatory Affairs professional with 4+ years of experience in ICSR case processing, adverse event reporting, RCA/CAPA quality compliance, and regulatory document publishing at Cognizant Technology Solutions. Proficient in Argus safety database management, MedDRA and WHO-DD coding, and publishing of PSUR, PBRER, DSUR, RMP, and CTR reports in compliance with FDA, EMA, and ICH GVP guidelines. Holds a Bachelor of Pharmacy degree (Distinction). Adept at cross-functional collaboration, medical redaction, error trend analysis, and leveraging Gen AI tools to improve workflow efficiency.