Summary
Overview
Work History
Education
Skills
Otherworkresponsibilities
Timeline
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MEGHANA MADDILLI

Chicago,Illinois

Summary

Accomplished pharmacovigilance professional with over five years of experience in patient safety, regulatory compliance, and the effectiveness of pharmaceutical products. Currently pursuing a master’s degree in health informatics to enhance clinical data management capabilities. Demonstrated expertise in drafting safety reports, including PBRER, PSUR, and PADER, alongside comprehensive knowledge of pharmacovigilance guidelines and MedDRA. Committed to leveraging drug safety experience to optimize healthcare processes and improve patient outcomes.

Overview

7
7
years of professional experience

Work History

Clinical Analyst Intern

Zmedi HealthCare
Chicago, IL
01.2025 - Current
  • Generated patient visit reports, ensuring accurate data collection.
  • Compiled lab completion statistics across multiple office locations, categorized by provider and month.
  • Managed and structured data reporting for all providers, including historical records for former staff.
  • Ensured compliance with data privacy standards by tailoring reports with and without patient DOB details.
  • Utilized healthcare information systems to streamline reporting and enhance clinical workflow efficiency.

Drug Safety Scientist

Qinecsa
Mysore, India
05.2020 - 08.2023
  • Review data entered in the safety database for completeness and accuracy
  • Provide quality feedback to team resources
  • Review and evaluate AE case information to determine required action based on and following internal policies and procedures
  • Delegate tasks and responsibilities to appropriate personnel
  • Perform any other drug safety-related activities as assigned
  • Enter and code, as applicable, case data, including but not limited to event, seriousness reported causality (when appropriate), medical history, and laboratory data as provided by the reporter
  • Performed quality review of NIS, Spontaneous (LP, PMS, and line listing cases) to reassess case validity, event selection, and seriousness and performed quality check which included verifying critical fields in conformity to E2B standards, including but not limited to reportability
  • Correct the data entry errors, if any, before routing the case in the global safety database
  • Track and document all observations and recommendations on the defect tracker
  • Assisted sellers with policy violations and allocated time to provide a plan of action to avoid losing selling privileges

Junior Data Analyst

Cognizant Technology Solutions
Hyderabad, India
01.2018 - 04.2020
  • Responsible for case intake of received Individual Case Safety Reports (ICSRs)
  • Checking the validity of the case and performing duplicate checks
  • Book-in of cases received from different sources (through CO, EV, LP, and manual book-in)
  • Entry of minimal data in book-in and routing to the next appropriate workflow
  • Rejection of case (invalid case), if does not meet the minimal criteria
  • Prioritize cases according to regulatory and project/client requirements
  • Responsible for data entry of ICSRs into the safety database based on information provided in source reports
  • Responsible for initial coding of applicable terms (Event, Drugs/ Procedures, etc.) identified in a valid ICSR, according to applicable MedDRA and WHO-DD dictionaries
  • Assessing seriousness, and causality and performing labeling for all the events reported in the source document
  • Writing narratives: Create complete, accurate, and precisely adhering to established processes
  • Data validations i.e., cross-checking against source documentation
  • Ensure integrity and completeness of data according to applicable regulations and guidelines, SOPs, and project-specific guidelines
  • Involved as a mentor for new joiners and conducting training as required
  • Worked on special projects as per request from the client
  • Review and respond to e-mails after discussion with mentors/as appropriate and attend all appropriate meetings (client)
  • Involved with various SME activities (case processing-related queries) with the team to minimize errors improve quality and share new client updates within the team via e-mails
  • Conducting quality feedback meeting huddles with Team members and discussing the frequent errors identified in case processing and from clients
  • Involved in the analysis of error trends of associates and focusing on their continuous improvement/ identifying areas of improvement by giving refresher training if required
  • Preparation for participation in audits and inspections

Education

Master of Science Degree - Health Informatics

Governors State University
University Park, Illinois
05.2025

Bachelor of Pharmacy -

Vignan Pharmacy of College
Guntur, Andhra Pradesh, India
05.2017

Skills

  • Adverse event case processing
  • Regulatory reporting
  • Quality metrics preparation
  • Microsoft Office Suite
  • Safety databases
  • Healthcare IT tools
  • Project management platforms
  • Oracle Argus Safety

Otherworkresponsibilities

  • Involved as a mentor for new joiners and conducting training as required.
  • Worked on special projects as per request from the client. Review and respond to e-mails after discussion with mentors/as appropriate and attend all appropriate meetings (client).
  • Involved with various SME activities (case processing-related queries) with the team to minimize errors improve quality and share new client updates within the team via e-mails.
  • Conducting quality feedback meeting huddles with Team members and discussing the frequent errors identified in case processing and from clients.
  • Involved in the analysis of error trends of associates and focusing on their continuous improvement/ identifying areas of improvement by giving refresher training if required.
  • Preparation for participation in audits and inspections.

Timeline

Clinical Analyst Intern

Zmedi HealthCare
01.2025 - Current

Drug Safety Scientist

Qinecsa
05.2020 - 08.2023

Junior Data Analyst

Cognizant Technology Solutions
01.2018 - 04.2020

Master of Science Degree - Health Informatics

Governors State University

Bachelor of Pharmacy -

Vignan Pharmacy of College

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