Kiran Sonawane

Authored/reviewed PBRERs, PSURs & ACO per EMA, GVP, ICH E2C(R2) & local regulatory requirment Drafted/reviewed DSURs integrating trial data, signals & cumulative findings Synthesized/evaluated Argus, ARISg, EMA, PSUSA, RMP, Signal & Literature inputs for benefit‑risk Maintained/reviewed PSMF ensuring GVP Module I compliance Supported inspections/audits improving compliance +20% via CAPA Acted as team manager (5), optimizing tasks & reducing delivery times 15%.

Led signal management across FAERS, VigiBase & EVDAS ensuring detection/validation/assessment via disproportionality analysis & ICSR review Authored/reviewed SERS, SDRs & MERS per EU GVP IX & ICH guidelines Championed cross‑functional initiatives with clinical/regulatory teams for risk mitigation & timely delivery Prepared DSURs with clinical/regulatory/biostatistics teams Managed SOPs ensuring compliance with quality standards & global regulations Acted as SME in audits/inspections ensuring readiness

Prepared and QCed PSURS, PBRERS, and ACOs in compliance with global regulatory standards Led internal stakeholder meetings to plan timelines, align on data sources, and ensure cross-functional input for aggregate report development Led comprehensive literature surveillance initiatives, resulting in improved signal detection processes and timely regulatory compliance Led risk management strategies and supported regulatory authority inspections focusing on compliance with ICH E2C and GVP guidelines

Efficiently processed ICSRs across diverse sources in Argus Safety, ensuring regulatory compliance through meticulous triage, coding, and quality review. Assessed listedness using key safety documents, collaborated with QA teams, and tracked process metrics to enhance data integrity and operational excellence.