Sanjana Kesarwani

Safety & Pv Specialist i @Syneos Health

Gurugram, IN

Skilled in utilizing tools like Argus Safety database and Veeva Vault.• Leveraging automated systems in triaging and case processing of all report types in compliance withICH-E2A and GVP guidelines.• Managing product complaints and experienced in device cases.• Expertise of 2.5 years in quality review of processed cases. Ensure MedDRA coding, data entry, and narrative writing are accurate.• Created detailed follow-ups to address unresolved issues or queries.• Timely case completion with minimal delays, managing workload efficiently.• Submitted cases to global regulatory authorities and reduced narrative errors by 20%.• Trained and mentored junior team members.• Assisted in project planning and coordination of safety operations. Participated in audit readiness orclient inspections.• Contributed to monthly workload tracking and compliance reports.• Improved turn around time leading to timely completion of cases.