Jyotsna Digra

Background

About Jyotsna Digra

Being a dental graduate, with hands-on clinical experience developed the understanding of patient care and management have transitioned to non-clinical field to use my healthcare strategy, operations and innovation. I am working as Drug safety associate l at Parexel international and have been trained for the management of Individual case safety reports (ICSRs)which includes: the triage of ICSRs to determine whether they qualify for expedited reporting. Book-in of ICSRs into the safety database. Conducting duplicate searches prior to book-in and identifying potential duplicates. Data entry of ICSRs in the safety database, including determining the expectedness of adverse events against various labelling documents, case narrative and assessing causalities if needed in the Argus Safety database. Data validation including the cross checking against source documentation and experienced in MedDRA coding in accordance with MedDRA Term and, Selection & WHO drug dictionary for coding. Trained for good working knowledge of the AE safety profile of assigned drugs, Reference Safety Information documents, data entry conventions and guidelines, client's procedures and international drug safety regulations including ICH guidelines on safety and efficacy, FDA guidelines, CIOMS, New EU PV legislation. As Jyotsna, signifies light just like that my adaptability, flexibility, communication skills and problem solving fostered me to pass through the doors of darkness and brightness of pharmacovigilance with continuous learning and thriving nature to open stand the challenges in the way in which the clinical experience worked as the pathfinder. Let's connect and illuminate new paths together!