Debasmita Sikder

Experience

1. Product Owner

   Accenture

   Jan 2023 — Present

   R&D Systems,Regulatory,Pharmacovigilance,Argus,Empirica,Veeva Vault. Risk Management Plan (RMP)and Aggregate Safety Report Management(ASR) using Feith Orbit Application via OKTA app. Detailed study of the workflows of Core RMP,Local RMP (country specific), EU RMP,Core Additional Risk Minimization Measures(ARMMC),Local Additional Risk Minimization Measures(ARMML). Creation of User Requirement Specification Document,Computer System Regulatory Assessment Document,Computer System Validation Risk Assessment document,Validation and Test Plan,Technical Configuration Specs,Production System Release,Operational Performance Qualification,Tracebility Matrix, and Production Test Script. Creation of IT Admin SOPs,Business User Process SOPs,User Access Request Form. Reviewing all the deliverables with Business and Quality Assurance Team and obtainining their sign off via DocuSign. Tracking the changes in configuration and coordinating project issues/ requests with vendor in Feith JIRA application. Creation of Tracked items,Activities, Activity Templates,Milestone,Metrics in Feith Orbit Application for the appropriate Tracker Types. Conducting detailed Discovery sessions,configuration meetings with stakeholders. To create Periodic Safety Update Report(PSUR),Periodic Benefit Risk Evaluation Report,Development Safety Update Report(DSUR),Investigational New Drug Report( IND), Periodic Adverse Drug Experience Report( PADER), Addendum to Clinical Overview (ACO),Line Listing,Local Report and Safety Commitments. Knowledge on HARP(Horizon Argus and Reporting Platform) system that consists of Argus and Empirica for use by Horizon’s Patient Safety and Pharmacovigilance(PSPV) department. Working on Quality Actions -CAPA actions,Change Actions,Effectiveness Check,Extension Request Working on Quality Management System - Quality Events,Change Controls,Deviations,Stand Alone CAPAs. Vendor Management System- Scope of services, Audits,Qualifications,Schedules,Bona Fides Verification.