Summary

Overview

Work History

Education

Skills

Database & Systems

Accomplishments

Disclaimer

Languages

Timeline

Soujanya Kumari

Belthangady

Summary

Drug Safety Regulatory Submissions and workflow management lead, with extensive experience in pharmacovigilance and safety data management. Served as an Operations Specialist 2 at IQVIA, Bangalore, with a proven track record in establishing submission workflows, developing study documents, and ensuring compliance with regulatory requirements for drugs and devices. Skilled in Argus and Veeva Vault, with strong leadership and communication abilities. As a Medical Service Analyst at Accenture, was involved in managing adverse event cases and preparing critical narratives. Adept at using Microsoft Excel and Word to generate detailed reports. Career goal includes advancing expertise in operations management within the healthcare sector.

Overview

years of professional experience

Work History

Operations Specialist 2

IQVIA RDS India Pvt Ltd

Bangalore

05.2019 - 08.2025

As the regulatory submission and workflow management lead, I executed extensive project work on startup, maintenance and close-out activities.
Assessed safety data for the report to relevant authorities, ethics committees, institutional review boards, and investigators, per legislation, within a timeline and format compatible with the requirements.
Identified regulatory authorities, local operating companies, and license partners require case reports based on specific scenarios.
Established a submission plan for drug and device products in clinical trials and post-marketing projects.
Managed periodic submissions, including Development Safety Update Reports (DSUR), bi-monthly line listings (2MLL), six-monthly line listings (6MLL), quarterly reports, etc.
Managed automated scheduling and submission of regulatory reports through Argus, ensuring timely and accurate reporting.
Developed a Safety Management Plan, and job aids to establish the submission workflow.
Assisted in the development and maintenance of study documentation.
Track submission dates and be responsible for uploading submission packages to the safety database.
Trained to complete late logs for submission made late to HA, and file deviations.
Trained in writing issue summaries for any deviations, identifying root causes, and providing corrective and preventive actions.
Mailbox management, answering project-related queries, and filing submissions and acknowledgment documents.
Attend project team meetings, and provide feedback to the line manager on any challenges, issues, or successes.
Training of new associates.
Monitoring daily operations to ensure accurate case allocation and workflow management.
Generating and updating detailed metrics reports to support performance monitoring and continuous improvement.
Engaged in sponsor calls as required.

Medical Service Analyst

Accenture Service Pvt. Ltd

Bangalore

01.2016 - 04.2019

Supported intake processes by coordinating case-related activities.
Responsible for allocating and prioritizing the cases as per reports.
Responsible for case processing, as per the related SOP work document, Sponsor reference document, etc.
Responsible for case processing of adverse events ICSR in the ARGUS database.
Responsible for entering the data according to the source documents that are relevant to identifiable patients, reporter information, suspect adverse events, and suspect drugs.
Responsible for assessing the seriousness of the events and identifying IME events and DME terms.
Ensure scientific rigor through accurate, complete, and consistent data entry of adverse event (serious and non-serious AE) reports from source documents, with emphasis on timeliness and quality.
Use the medical dictionaries MedDRA and WHO DD Dictionary to code data related to medical history, drug indications, adverse event terms, and appropriate selection of drug names.
Responsible for writing case narratives and summarizing the essential details of the case (PSUR).
Determine if appropriate case follow-up has been considered. Conduct follow-up activities when needed.
Act as the SME for the team, coordinate/conduct sessions as part of CAPA and refresher training, as per the team’s requirements, and document the training.
Responsible for data security with regard to prohibited health information.
Ensure that all case-related emails, source documents, and other relevant information are archived in the case folder within the core Global Safety database.
Initiate and handle case suppression or nullification as appropriate.
Route the case to the next step for in-line QC or distribution.

Education

Bachelor of Pharmacy -

Karavali College of Pharmacy

Mangalore

01.2014

Pre University -

Sri Bhuvanendra Pre-University College

Karkala

05.2010

Matriculation -

Canara High School

Urva-Mangalore

03.2008