Jatin Mali

About Jatin Mali

I am a dedicated clinical research professional with a Master’s in Pharmacy, a Diploma in…

Experience

1. Senior Process Executive

   Cognizant

   Mar 2021 — Present · Mumbai, IN

   Clinical Data Management: I excel in discrepancy and query management, ensuring data integrity by identifying and resolving inconsistencies. I perform manual reviews, manage screen failure subjects, and address Disqus query exceptions, ensuring compliance with study protocols and regulatory standards. My expertise in Medidata Rave includes holistic dataset assessments to verify clinical trial data accuracy and completeness. I oversee database lock activities, addressing issues during the lock process to ensure a seamless database freeze, with a focus on oncology to support high-quality cancer research outcomes.ICSR Case Processing: I handle thorough ICSR case processing for both serious and non-serious adverse events in the Oracle Argus safety database. This includes managing a variety of report types, authoring detailed narratives for initial and follow-up cases, and generating follow-up queries to ensure comprehensive information in adverse event reports.Medical Coding: I proficiently code adverse events and patient histories using the MeDRA dictionary, accurately identifying suspect products and concomitant drugs through tools like the CDD and WHO drug dictionary.Quality Assurance and Compliance: I conduct labeling assessments for adverse events, ensuring compliance with regulatory guidelines for adverse event reporting, while adhering to applicable laws and regulations.