Akanksha Gajula

Background

About Akanksha Gajula

Cumulative 9 years of experience in handling post marketed non interventional study, solicited, spontaneous, literature and Clinical trial cases. Along with Mailbox and Team management.• Also working as a mailbox monitor for Office of Consumer Medical Safety mailbox, OCMS GCR OTC mailbox and Adverse event- PQC mailbox and maintaining project-specific email accounts. • Processing literature, spontaneous, as well as clinical trial cases and ensuring accurate data-entry. • Execute drug safety data management processes – a combination of case intake, triage, case entry, medical coding, narrative writing, peer review, call intake, case follow-up, report preparation and submission to regulatory authorities • Perform any other support activities as assigned – tracking various types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple sources including literature search. • Responsible for the receipt, acknowledgement and timely respond to all e-mail communications received via different stakeholders. • Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures. • Good understanding of International Pharmacovigilance regulations: ICH-GCP guidelines and Health canada. • Handling non serious line listing as well as follow up questionnaires. • Familiar with ARGUS, Sceptre, Arisg G and MedDRA.