Harika Medisetti

I am a meticulous medical reviewer with a Bachelor of Dental Surgery and over two years of hands-on experience in pharmacovigilance, focused on ensuring the accuracy and integrity of medical content.

I have conducted comprehensive medical reviews of individual case safety reports (ICSRs), assessing causality, seriousness, and expectedness of adverse events while ensuring compliance with regulatory standards.

I collaborate closely with cross-functional teams including data entry specialists, case processors, and safety scientists to resolve discrepancies, support signal detection, and maintain audit readiness.

I maintain strong familiarity with MEDDRA coding, global regulatory requirements (ICH GCP, GVP, MHRA, EMA), and tools such as Microsoft Office; I prioritize reducing data gaps and timely regulatory reporting.