Sudheer Kumar Therala
Hyderabad
Summary
Experienced Data Analyst with 7 years of expertise in medical device compliance handling, clinical research, clinical trials, biomarker databases, hospital pharmacy, and dispensing. Extensive knowledge of clinical trial procedures and the clinical practice standards set by the Food and Drug Administration (FDA). Seeking an opportunity to leverage skills and creativity in a dynamic organization that values growth and innovation.
Overview
12
12
years of professional experience
6
6
years of post-secondary education
Work History
Data Analyst
Cognizant Technology Solutions Ltd
03.2022 - 09.2024
- Worked on compliance management in medical devices on cases, collects the data and resolve the complaint received from customer and also the technical support
- Performed Review, evaluation, classification, reportability criteria and follow up activities on medical devices product complaints. Summarize investigation results based on technical analysis.
- Followed medical device product specifications.
- Receives complaint information, evaluate and database it
- Prepared, updated and submited Medwatch 3500A Report, Health Canada Report, MIR Report, IRIS Form for initial, follow-up and final reporting related to respective regulatory authorities within specified timelines
- Performed Failure coding, Event coding, Hazard coding activities.
- Performed follow up report to gather more information and handling product returns activities
- Assessed complaints to determine if complaint meets reportability criteria for submission to Health Authorities.
- Performed trend analysis by utilizing complaints data from database of specific period
- Worked on Class I and Class II devices.
- Perform GDT for reportability decision making.
- Write investigation summaries based on technical product analysis data.
- Work with other teams such as PMS, Investigation and QA team.
- Review and perform activities related to complaint closure.
- Perform internal trainings for quality and accuracy of data.
- Performs quality check of submitted report.
- Worked on secondary and market research to collect data from pharmaceutical companies.
- Validated clinical data from clinical trial registries, regulatory, journals, company pipeline, company presentations, SEC filings, consensus forecasts, financial reports, news, earnings, deals and conferences.
- Worked on data collection and result writing
- Tools: TrackWise, SAP, Salesforce, PowerBI, Agile and MS Office
Associate Analyst
GD Research Centre
11.2017 - 03.2022
- Work in conjunction with Clinical Research Associates, Clinical Project Managers on the Clinical Affairs team on Database and Data analysis
- Work closely with study project team to provide clinical study support
- Develop guidelines for data entry
- Conducts secondary research on markets, products or companies both written and data-based and collection of research articles from Government or Public reliable sources
- Works on Clinical Trials Database and Biomarker Database
- Works regarding disease related role tagging, biomarker discovery, biomarker profiling in Biomarker Database
- Works on results and report writings, press releases, conferences, sec
- Filings, financial reports
- Interacting regularly with teammates both formally, through team meetings etc., and informally
- Works on Microsoft Office tools including Excel, Word and PowerPoint
- Managing and tracking timelines to ensure timely delivery
- Maintaining the trackers related to work
- Conducting training sessions for new resources
- Works on Quality Check (QC)
Intern (Clinical Data Management)
Covalent Technologies
10.2016 - 10.2017
Clinical Pharmacist
Aditya Hospital
08.2012 - 10.2015
- Maintaining Inpatient pharmacy
- Dispensing of Inpatient Indents
- Interaction with doctors regarding prescriptions
- Maintaining stock value
- Audit Stock value & Reporting
Education
Bachelor of Pharmacy -
Bharat Institute of Pharmaceutical Sciences
Hyderabad 06.2007 - 06.2011
Diploma in pharmacy -
G Pulla Reddy College of Pharmacy
Hyderabad 06.2005 - 04.2007
Skills
Understanding of medical terminology
Medical device regulations - ISO13485
21 CFR Part 803
21 CFR Part 820
ICH-GCP
21CFR PART 11
undefinedTimeline
Data Analyst
Cognizant Technology Solutions Ltd
03.2022 - 09.2024
Associate Analyst
GD Research Centre
11.2017 - 03.2022
Intern (Clinical Data Management)
Covalent Technologies
10.2016 - 10.2017
Clinical Pharmacist
Aditya Hospital
08.2012 - 10.2015
Bachelor of Pharmacy -
Bharat Institute of Pharmaceutical Sciences
06.2007 - 06.2011
Diploma in pharmacy -
G Pulla Reddy College of Pharmacy
06.2005 - 04.2007
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