Summary
Overview
Work History
Education
Skills
Awards Accomplishments Honors
Projects
Timeline
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Bhavana Jajula

Bridgeport,CT

Summary

Data analyst in Drug Safety with six years of experience in pharmacovigilance, adverse event management, and regulatory affairs. Expertise in ensuring global compliance and navigating complex safety issues. A proactive and personable leader with top-notch skills in streamlining information, prioritizing tasks and approaching issues with an analytical mindset. Seeking to leverage extensive experience and forward-thinking approach in health informatics to drive innovation and optimize processes. Proficient in data analysis, technology integration, and informatics methodologies. Committed to shaping the future of pharmaceutical safety and improving patient outcomes through continuous learning and professional growth.

Overview

9
9
years of professional experience

Work History

Data Analyst

Cognizant
04.2021 - 11.2023
  • Contributed to the development of Standard Operating Procedures related to Pharmacovigilance activities in ARGUS SAFETY DATABASE
  • Maintained accurate records of drug safety data in accordance with regulatory requirements
  • Quality review of data entry of case processors to evaluate consistency, completeness, and accuracy in safety database and providing feedbacks for them via documented observation tracker
  • Evaluate medical coding of adverse events, drugs, medical and past drug history, indications, and diagnostics using MedDRA
  • Writing a detailed medically oriented description of events in form of safety narrative
  • Communicate observations to other associate analysts to improve quality
  • Query raising to clients in case of any conventional issues
  • Point of contact for queries to the medical team from the whole site
  • Back up for Team lead and also POC for quality of team
  • Conducting huddles for new updates on conventions and also for correction-related discussion for the whole site
  • Documentation of MOM for the huddles conducted
  • Leveraged SQL queries to extract, transform and load data into databases.

Drug Safety Associate II

Bioclinica
09.2020 - 04.2021
  • Contributed to the development of Standard Operating Procedures related to Pharmacovigilance activities in ARGUS SAFETY DATABASE
  • Maintained accurate records of drug safety data in accordance with regulatory requirements
  • Performing review after data entry of other associates along with completion of data entry from source documents to safety database along with evaluation of consistency, completeness, accuracy in safety database, tracking database and source document, evaluate medical coding of adverse events, drug, medical and past drug history, indications, and diagnostics using MedDRA
  • Writing a detailed safety narrative
  • Documentation case related observations in tracker, communicate observations to other associate analysts and also Query raising to higher level in case of any conventional issues.

Associate Analyst

Tech Mahindra
11.2015 - 08.2018
  • Review of source documents in the individual case safety reports for assigned cases in the project
  • Perform the duplicate search in ARGUS SAFETY DATABASE
  • Completion of data entry from source documents to safety database along with evaluation of consistency, completeness, accuracy in safety database, tracking database and source document
  • Evaluate the medical coding of adverse events, drug, medical and past drug history, indications, and diagnostics using MedDRA
  • Writing a detailed medically oriented description of the events in the form of safety narrative
  • Worked in Legal Case Processing.

Research Analyst

Siri Healthtech Solutions
11.2014 - 06.2015
  • Analyze the patient clinical data required for the specification with respect to the claim act.
  • Allocating tasks according to streamlined operations and prioritized tasks.
  • Making patients data in chronological order and review.

Education

Masters in Healthcare informatics -

Sacred Heart University
Fairfield
03.2025

Doctor of Pharmacy -

Vaagdevi College of Pharmacy, Warangal.
Warangal, Telangana, India
12.2012

B. Pharmacy -

JJ College of Pharmacy, Maheshwaram.
Hyderabad, Telangana, India
04.2009

Skills

  • Worked on Oracle Argus and ARISg databases
  • Well-versed with Pharmacovigilance
  • Practical knowledge in the Clinical Trial Process
  • Knowledge of monitoring procedures in Prescription Event Monitoring (PEM)
  • Patient counseling along with prescribed medication use
  • Knew CDM and CRF design
  • Knowledge on Database Design, Query writing
  • Knowledge of Discrepancy Management
  • Knowledge on SOP writing
  • Knowledge in using OpenClinica clinical trial software

Awards Accomplishments Honors

  • Got Best Employee Awards twice in Cognizant.
  • Recognized as SME and POC for process knowledge, query raising, and resolving in-between case processing team and medics for the whole site.
  • Participated in role plays, Group Discussions and Presentations.

Projects

● Interventional study titled “Is Nephrozone influences microalbuminuria in chronic kidney disease patients?”.

● Pharmaceutical project titled “Influence of various concentrations of polymer on In-Vitro dissolution rate of Itraconazole”.

Timeline

Data Analyst

Cognizant
04.2021 - 11.2023

Drug Safety Associate II

Bioclinica
09.2020 - 04.2021

Associate Analyst

Tech Mahindra
11.2015 - 08.2018

Research Analyst

Siri Healthtech Solutions
11.2014 - 06.2015

Masters in Healthcare informatics -

Sacred Heart University

Doctor of Pharmacy -

Vaagdevi College of Pharmacy, Warangal.

B. Pharmacy -

JJ College of Pharmacy, Maheshwaram.

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Bhavana Jajula