parul singla

Drug Safety Associate II

• Job Details:Directed portfolio of entire process of PV activities involving 8 people dealing with UK and Irish market in improving customer satisfaction, resulting in 50% increase in positive feedback and 20% reduction in complaints. Compiled and analyzed individual performance metrics for 8-member team, ensuring alignment with service level agreements (SLAs), which contributed to noticeable improvement in overall productivity levels within department. Timely completion of assigned work to meet service level agreement (SLA) and turnaround time (TAT), and responsible for compliance and quality. Acted as SME for entire global PV activities and as a significant point of contact for case management of ICSRs as part of country pharmacovigilance outsourcing centre. Facilitated new strategies for process improvement, amplifying client engagement, resulting in 40% efficiency in productivity. Performed ICSR submission to local health authorities and/or ethics committees in line with regulatory requirements. Conducted compliance investigations (lateness reasons), root cause analysis (RCA), corrective and preventive actions (CAPA). Developed and maintained literature search strategies tailored to stakeholder requirements. Assessed literature references for validity, categorizing them as valid ICSR, invalid, or non-case; maintained detailed logs for tracking. Implemented new ideas to simplify monthly billing for activities produced for the respective month, thereby reducing 20% of time and manual effort. Collaborated in data migration from Aware to Argus and organized all migration-related activities, including a stepwise flowchart for various processes in three stages: pre-transition, transition, and post-transition. Exercised follow-up requests and sent out queries to reporters for additional/missing information in cases and documented in global safety database as per SOPs. Implemented the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. Supported in preparation/review of periodic safety update report (PSUR). Management of ICSRs of all case types including triage, duplicate search, preparation of ISI forms and data entry of ICSRs in the safety database.