Swetha Vantapati
Novi,MI
Summary
Accomplished Clinical Research Associate with 2.5 years of experience performing and documenting pre-study site evaluations, regulatory document review, interim monitoring and study close-out visits. Diligent in performing studies aligned with good clinical practices and study-specific requirements. Good knowledge on data analytics and visualization techniques using SQL, R and Tableau. Seeking full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.
Overview
1
1
Certification
Work History
Data Analytics Professional Certificate
Google
- Completed extensive six-month data analytics training from Google
- Demonstrated hands-on experience with data cleaning, data visualization, project management, interpreting and communicating data analytics findings
- Rigorous use of tools such as SQL, Spreadsheets, R and Tableau.
Clinical Research Associate
Aurobindo Pharma Limited (APLRC-1)
- Collected and reviewed literature from different regulatory sites (EU-SMPC, USFDA-Label, Canada- Product Monograph, New Zealand- Datasheet from MEDSAFE etc.,) for preparation of protocols for Phase-1 and BA/BE studies
- Designed and reviewed study protocols for solid orals, liquids, suspensions, and injections of various molecules for different HA submissions
- Monitored Bio studies, Site initiation visits, Close-out visits for studies outsourced to various CRO’s as per ICH-GCP and SOP’s
- Submitted study related documents to Indian regulatory for BENOC Application and Import License of reference drugs
- Handled outstanding queries from DCGI with respect to BENOC filings
- Tracked all study related DCGI documents (i.e., NOC, Permissions and covering letters) regardless of the molecule to streamline the smooth execution of BE studies.
Research Internship
Aurobindo Pharma Limited (APLRC-1)
- Reviewed Clinical and Bioanalytical study reports of BA/BE of various drugs for different HA submissions
- Reviewed drug studies of healthy subjects and patients viz., Case Report Forms (CRF’s) for over 50 drug molecules for US-FDA, Europe, Canada, and Brazil regulations
- Reviewed Adverse events (AE) and Serious adverse event (SAE) forms of the study subjects of various studies and tracked the follow-up of the events and updated the resolution forms
- Supported other stake holders (i.e., Regulatory) regarding queries of different regulatory submission of clinical studies for different regulations
- Prepared and reviewed Bioequivalence Data summary tables for USFDA submissions and on-time submission of BA/BE study related documents for regulatory submissions.
Education
Master of Pharmacology -
JNTUK
IndiaBachelor of Pharmacy -
Andhra University
IndiaSkills
Data Analysis
- Data Cleaning
- Data Visualizations
- Data Driven Decisions
- Data Integrity
Software Tools
- Spreadsheets
- SQL
- R Programming
- Tableau
Regulatory Guidelines
- US FDA GMP
- EMA
- ICH
- Health Canada
Core-Pharmaceutical
- Protocol design & review
- Drug monitoring
- Site initiation & close-out visits
- Drug accountability
Certification
- Google Data Analytics
- Registered Pharmacist at AP Pharma Council, India
Additional Information
VISA SPONSORSHIP IS NOT REQUIRED AND AUTHORIZED TO WORK FOR ANY EMPLOYER
Timeline
Data Analytics Professional Certificate
Google
Clinical Research Associate
Aurobindo Pharma Limited (APLRC-1)
Research Internship
Aurobindo Pharma Limited (APLRC-1)
Master of Pharmacology -
JNTUK
Bachelor of Pharmacy -
Andhra University
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