Dhanak Razdan

Background

About Dhanak Razdan

Experienced in Managing ICSRs of various case types, Conducting triage for expedited reporting, determined submission timelines to regulatory authorities.Identified potential duplicates before Book-in and performed data entry in the safety database (ARGUS safety database). Proficient in MedDRA. Maintained knowledge of data entry conventions and international regulations for vaccines and drugs, including ICH guidelines on safety and efficacy, New EU PV legislation, GVP modules, and FDA guidelines. Ensured compliance with global regulatory reporting obligations, organized workload for timely ICSR processing.Mentoring and training PV scientists on ICSR process intake and processing. Proficient in RSI assessment.PUBLICATION:• Published a research article on "The Prescription Pattern Analysis of tubercular treatment in TB & Chest Department in Tertiary care Teaching Hospital" in Indian Journal of Public Health Research and Development (IJPHRD) and recently working on a review article.