Summary
Overview
Work History
Education
Skills
Other Work Responsibilities
Certification
Timeline
Generic

MEGHANA MADDILLI

Chicago

Summary

Pharmacovigilance professional with over five years of experience in patient safety and regulatory compliance. Proficient in drafting safety reports such as PBRER, PSUR, and PADER, with a strong understanding of pharmacovigilance guidelines and MedDRA. Holds a master's degree in health informatics, enhancing expertise in healthcare technology to improve patient outcomes. Background in technology roles includes software development, system administration, and technical support, emphasizing performance optimization and project management.

Overview

7
7
years of professional experience
1
1
Certification

Work History

Clinical Analyst Intern

ZMEDI HEALTHCARE
Chicago
01.2025 - 05.2025
  • Managed patient records using eClinicalWorks to optimize clinical workflows.
  • Generated patient visit reports, ensuring precise data collection.
  • Compiled lab completion statistics across multiple office locations, organized by provider and month.
  • Structured data reporting for all providers, including historical records for previous staff.
  • Ensured compliance with data privacy standards through tailored report configurations.
  • Utilized healthcare information systems to enhance reporting efficiency and workflow.

Drug Safety Scientist

QINECSA
Mysore
05.2020 - 08.2023
  • Reviewed data in safety database for accuracy and completeness.
  • Provided quality feedback to team members to enhance performance.
  • Evaluated AE case information to determine necessary actions per internal policies.
  • Delegated tasks to appropriate personnel to ensure efficient workflow.
  • Entered and coded case data, including events, seriousness, causality, medical history, and laboratory results.
  • Conducted quality reviews of NIS, spontaneous cases, and line listings to assess validity and compliance with E2B standards.
  • Corrected data entry errors prior to routing cases in global safety database.
  • Tracked observations and recommendations on defect tracker for continuous improvement.

Junior Data Analyst

COGNIZANT TECHNOLOGY SOLUTIONS
Hyderabad
01.2018 - 04.2020
  • Executed case intake for Individual Case Safety Reports (ICSRs) to ensure compliance.
  • Performed validity checks and duplicate screenings on incoming cases.
  • Processed cases received from various sources, including CO, EV, LP, and manual entries.
  • Entered essential data and routed cases to appropriate workflows for efficiency.
  • Rejected invalid cases that did not meet minimum criteria standards.
  • Prioritized cases based on regulatory guidelines and project requirements.
  • Conducted initial coding of relevant terms according to MedDRA and WHO-DD dictionaries.
  • Mentored new team members and provided training as necessary.

Education

Master of Science - HEALTH INFORMATICS

Governors State University
University Park, Illinois
05.2025

Bachelor of Science - BACHELOR OF PHARMACY

Vignan Pharmacy of College
Guntur, Andhra Pradesh, India
05.2017

Skills

  • Pharmacovigilance protocols
  • Regulatory reporting
  • Microsoft Office Suite
  • MedDRA coding
  • Argus Safety database management
  • eClinicalWorks (EMR systems)
  • SQL proficiency

Other Work Responsibilities

  • 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 minimizing errors, improving quality, and sharing 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.

Certification

  • Certified in Data Analytics: Intro to SQL using Healthcare Data from UDEMY

Timeline

Clinical Analyst Intern

ZMEDI HEALTHCARE
01.2025 - 05.2025

Drug Safety Scientist

QINECSA
05.2020 - 08.2023

Junior Data Analyst

COGNIZANT TECHNOLOGY SOLUTIONS
01.2018 - 04.2020

Master of Science - HEALTH INFORMATICS

Governors State University

Bachelor of Science - BACHELOR OF PHARMACY

Vignan Pharmacy of College
MEGHANA MADDILLI