With a Bachelor’s degree in Dental Surgery from Punjab University, India, she has a hands-on experience in processing of end-to-end Individual Case Safety Reports (ICSRs) – including both Spontaneous and Solicited, Literature Triage, MedDRA coding, Narrative Writing, Quality review and Regulatory Submissions. With an exceptional record of performing safety reporting for over 300+ drugs for top pharma companies in the industry, she has a well-rounded cumulative knowledge of regulatory compliance with FDA, Health Canada, EMA and TGA.

Kamaljit has also worked on processing and reporting of SUSARS from clinical trials (Phase 2-4) for a variety of indications. Being extremely detail and deadline oriented, she is excellent at Aggregate Report Writing including Periodic Safety Update Reports (PSURs) and United States Periodic Adverse Drug Experience Reports (PADERs).

 Kamaljit truly believes in understanding the client needs and deliver them nothing but the ‘Best’.