Monika Pandey
Consultant @IQVIA
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WORK HISTORY
Consultant @IQVIA
Bengaluru, IN
usiness Enablement (BE) leadership, SME, trainer, and reporting lead.Skilled in Requirements Elicitation, Fit-Gap Analysis, workshops, Requirement Analysis and Requirement Gathering. I have helped pharma companies being compliant in reporting adverse events to local/regional regulatory bodies like FDA, EMEA, PMDA (Expedited and Periodic Reporting)Development of custom reports - Skilled in Requirements Elicitation, Fit-Gap Analysis, workshops, Requirement Analysis and Requirement Gathering. Role in system configuration, implementation, validation, and validation strategy across deliverables like Configuration Specification Document, UFRS, VP, RTM, IQ, OQ, UAT, VSR, CFR Part 11Development and Testing of Custom reports - periodic reports (DSUR, PBRER, PADER, PDLL) and various operational reports for clients.Work on tools like Argus, IQVIA vigilance platform (Collect, Intake, Case, Submission, Periodics, Analytics and Signal), Cognos, Looker, OBIEE
EDUCATION
West Bengal University of Technology
M Pharm; B Pharm
West Bengal University of Technology,Kolkata
M pharma
West Bengal University of Technology
Master of pharmacy
SKILLS
ABOUT MONIKA PANDEY
Summary • Experience: Global IT with 12 years in Pharmacovigilance, Life Sciences, and…
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