WEBSITES,

PORTFOLIOS,

PROFILES

PROFESSIONAL

SUMMARY

SKILLS

WORK HISTORY

SWETHA VANTAPATI

■ Novi, MI 48377 ■ 512-***-**** ■ ad35xd@r.postjobfree.com ■ WWW: Bold Profile ■

• https://www.linkedin.com/in/swetha-v-5b60888a/

• https://bold.pro/my/swetha-vantapati-240********* 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.

Data Analysis

Software Tools

Regulatory Guidelines

Core-Pharmaceutical

• Data Cleaning

• Data Visualizations

• Data Driven Decisions

• Data Integrity

• Spreadsheets

• SQL

• R Programming

• Tableau

• US FDA GMP

• EMA

• ICH

• Health Canada

• Protocol design & review

• Drug monitoring

• Site initiation & close-out visits

• Drug accountability

DATA ANALYTICS PROFESSIONAL CERTIFICATE

Google, Online

• 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

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• Rigorous use of tools such as SQL, Spreadsheets, R and Tableau. CLINICAL RESEARCH ASSOCIATE

Aurobindo Pharma Limited (APLRC-1), India

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

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Designed and reviewed study protocols for solid orals, liquids, suspensions, and injections of various molecules for different HA submissions

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Monitored Bio studies, Site initiation visits, Close-out visits for studies outsourced to various CRO's as per ICH-GCP and SOP's

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EDUCATION

CERTIFICATIONS

ADDITIONAL

INFORMATION

Submitted study related documents to Indian regulatory for BENOC Application and Import License of reference drugs

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• 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.

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RESEARCH INTERNSHIP

Aurobindo Pharma Limited (APLRC-1), India

Reviewed Clinical and Bioanalytical study reports of BA/BE of various drugs for different HA submissions

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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

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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

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Supported other stake holders (i.e., Regulatory) regarding queries of different regulatory submission of clinical studies for different regulations

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Prepared and reviewed Bioequivalence Data summary tables for USFDA submissions and on-time submission of BA/BE study related documents for regulatory submissions.

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Master of Pharmacology

JNTUK - India

Bachelor of Pharmacy

Andhra University - India

• Google Data Analytics

• Registered Pharmacist at AP Pharma Council, India VISA SPONSORSHIP IS NOT REQUIRED AND AUTHORIZED TO WORK FOR ANY EMPLOYER

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