Krupali Chudasama

About Krupali Chudasama

Passionate industry professional with experience to work in global environment with US EU…

Experience

1. Senior Pharmacovigilance Associate

   Apcer Life Sciences

   Oct 2020 — Present

   Submission in R2 and R3 XML formate (including 15-day alert, periodic, PADER) to EMA,MHRA,Health canada and FDA and tracking acknowledgement • Oversight of ICSR submission related activities including retrospective review of ICSR submissions, manual submissions, track and maintain submission trackers. • Investigator alert letters creation, review and approve as per sponsor guidance. • Intake oversight activities including mail box management, ICSR follow-up oversight, non-case review, social media reports handling and reconciliation of reports with global database. • ICSR follow-up oversight including monthly report extraction from ARGUS database, prepare to identify the non compliant action items specific to affiliates, obtain feedback from affiliates, review and prepare final metrics and present in quality forums. • Significant contribution to the strategy, draft and review of follow-up oversight activity. • Developed a strategy in association with manager, to prepare metrics in an automated excel sheet. Trainer: Training the team members with ICSR process and pharmacovigilance principles. • As a quality check reviewer- review and evaluate the processed cases as per quality review checklist in terms of quality, accuracy, and completeness against the source documents provided. Provide quality feedback to the team resources and initiate necessary corrections as per guidelines. • Identify quality issues, obtain RCA and evaluate. • Initiate CAPA, track and evauate effectiveness. • Derive insights from quality data and initate ICSR quality improvement processes • Mentor new resources • Client facing • Extract and Develop metrics and present in quality meetings • ICSR reconciliations • Project mail box management