Monika Pandey

Consultant @IQVIA

Bengaluru, KA, IN
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

May 2015 — Present

Consultant @IQVIA

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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

2009 — 2011

West Bengal University of Technology

M Pharm; B Pharm

2009 — 2011

West Bengal University of Technology,Kolkata

M pharma

2009 — 2011

West Bengal University of Technology

Master of pharmacy

SKILLS

PharmacovigilanceIch-GcpClinical Data ManagementOracle ClinicalRegulatory SubmissionsClinical TrialsCROE2bMedical WritingArisgRegulatory AffairsPharmaceutical IndustrySopDrug SafetyGcpMeddraClinical

ABOUT MONIKA PANDEY

Summary • Experience: Global IT with 12 years in Pharmacovigilance, Life Sciences, and…

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Monika Pandey — Consultant at IQVIA in Bengaluru, KA, IN | Unifers