Kiran Sonawane

Led comprehensive signal management using FAERS, VigiBase, EVDAS, and literature tools, including validation, reporting, and committee coordination. Authored regulatory-compliant signal and aggregate reports, supported labeling updates, and collaborated cross-functionally across clinical, regulatory, and biostatistics teams. Delivered team training, ensured QC oversight, and maintained audit readiness through meticulous documentation and stakeholder engagement.

Drafted and reviewed PBRERs, DSURs, and ACOs for global clients, ensuring documentation accuracy through evaluation of safety narratives, line listings, and tabulations. Performed peer reviews and QC checks aligned with ICH E2C (R2) and GVP guidelines, while coordinating cross-functional teams to deliver timely, compliant reports. Maintained trackers, supported audits, and resolved stakeholder queries, alongside training new team members in pharmacovigilance writing standards and regulatory expectations.

Oversaw end-to-end preparation of aggregate safety reports (PSURs, PBRERs, DSURs, ACOs) in compliance with EMA and FDA regulations. Led internal planning meetings, generated Argus-based safety listings, and conducted thorough literature surveillance from search string creation to full documentation. Maintained regulatory traceability through audits and reconciliations, and delivered hands-on training to enhance team proficiency in report authoring and literature review.

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.