Krishna K.

1) Worked with IQVIA RDS as Operations Specialist 1 from July 2018 to September 2017. • Participating in the triage process for incoming documents (solicited, spontaneous and clinical trial reports) to ensure timely and effective, medical and scientific evaluation of adverse event information • Registering of ICSRs in the safety database • Data entry of ICSRs in the safety database, including determining the expectedness of adverse events against various labeling documents (such as SPC, CDS, IB, etc.), writing case summaries, seriousness, assessing causalities and writing company comment if required • Experienced in MedDRA coding • Submission of ICSRs to regulatory authorities • Following up with consumers and health care professionals • Updating working knowledge of the AE safety profile of assigned drugs/class of drugs, reference safety information documents, data entry conventions and guidelines, client’s procedures and international drug safety regulations including ICH guidelines FDA guidelines, CIOMS, EU PV Legislation • Maintaining awareness of global regulatory reporting obligations • Organizing work