Sravani Kumari Kota
Hyderabad
Summary
Experience and Knowledge in Quality Management System(QMS), Contract Manufacturing Operations(CMO) QA GMP/GDP SOP Management, Training Management Literature Review in clinical trials, Experience in Review and Quality Checks for Clinical Outcome Database Curation and Review of source database and outcome database across multiple therapeutic areas
Overview
9
9
years of professional experience
Work History
Research Analyst
Excelra Knowledge Solutions Pvt Ltd.
11.2020 - Current
- Review and Quality checks of outcome database
- Documentation and Protocol design
- Giving feed back to curators
- Maintaining quality reports and error reports, status tracker o team members
- Work closely with project manager and domain experts, support them throughout specification validation process and eventually contribute to comprehensive systems and processes
- Work closely with quality analysts and project managers them for evolving and validating quality and productivity benchmarks
- Save procured literature in designated copyrighted location with restricted access
Clinical Data Analyst Level-2
Certara Pvt Ltd.
12.2019 - 11.2020
- Literature review
- Curation and Review interpreted and extracted medical literature (PUBMED, EMBASE, COCHRANE, and Clinicaltrials.gov etc.) in clinical domain as per client defined, format and specifications across multiple disease areas
- Extraction of data from graphs by using Engauge, X-Y scan (Digitization)
Jr. Research Analyst
GVK Informatics
10.2017 - 11.2019
- Curation and Review of source database and outcome database across multiple therapeutic areas.
Jr. Executive
GVK Biosciences
06.2015 - 10.2017
- Review of master & executed Batch manufacturing & packing records and release of batches
- Quality Management System(QMS), Knowledge of Contract Manufacturing Operations(CMO)
- SOP Management, Training Management
- Corrective Action and Preventive Action(CAPAs)
- Risk Management, Compliance Management
Education
Masters in pharmacology - Masters in Pharmacy
JNTU University
Karimnagar, TG01.2015
Bachelor of Pharmacy -
JNTU University
Hyderabad, TG06.2012
Diploma in Pharmacy -
Osmania University
Hyderabad, TG01.2009
Intermediate Bi.P.C -
Trinity Junior College
Karimnagar, TG01.2006
Skills
- Team Player
- Resilience
- Communication Skills
- Self-Reliance
- Extraction of data from graphs by using Engauge, X-Y scan (Digitization)
- CTOD tool, SDB Automation tool
- Literature Search
- Editing of data by using Edit plus
- MS Office(Word, Excel and PowerPoint, Outlook)
Advanced Training
Actively participated in Two Days Workshop on HANDLING OF ANALYTICAL TOOLS organized by Vaageswari College of Pharmacy
Foreign Languages
English
Timeline
Research Analyst
Excelra Knowledge Solutions Pvt Ltd.
11.2020 - Current
Clinical Data Analyst Level-2
Certara Pvt Ltd.
12.2019 - 11.2020
Jr. Research Analyst
GVK Informatics
10.2017 - 11.2019
Jr. Executive
GVK Biosciences
06.2015 - 10.2017
Masters in pharmacology - Masters in Pharmacy
JNTU University
Bachelor of Pharmacy -
JNTU University
Diploma in Pharmacy -
Osmania University
Intermediate Bi.P.C -
Trinity Junior College
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