SAI SRAVANI VUYYURU
ALBANY
Summary
I have an in-depth understanding of pharmacy operations, having worked as a Pharmacy Assistant in both Australia and Canada, where I gained hands-on experience in medication dispensing, customer service, and regulatory compliance in pharmaceutical settings. Transitioning into medical writing, I held an Executive Medical Writing role in India, contributing to the development of clinical documentation, scientific publications, and regulatory submissions. Currently, as a Regulatory & Compliance Analyst II, I leverage my expertise in regulatory affairs, compliance, and risk management, ensuring strict adherence to international regulations. With a Bachelor's in Pharmacy and a Master's in Biotechnology, I bring a unique blend of scientific knowledge and practical experience across multiple industries.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Regulatory & Compliance Analyst II
Molloy Medical Arts Pharma INC
New York, United States Of America
12.2024 - Current
- Ensured compliance with federal, state, and international regulatory requirements (e.g., FDA, EMA, ICH, HIPAA) for pharmaceutical and healthcare products.
- Conducted internal audits and assessments of organizational processes and procedures to ensure adherence to regulatory standards and industry best practices.
- Assisted in the development and maintenance of company compliance policies and standard operating procedures (SOPs).
- Supported risk assessments related to regulatory and compliance issues, identifying potential risks and working with cross-functional teams to implement corrective actions.
Pharmacy Assistant
Parkdale Guardian Pharmacy
Toronto, Canada
08.2024 - 12.2024
- Accurately prepare and dispense medications as per prescriptions, ensuring proper dosage and instructions.
- Provide excellent customer service by addressing patient inquiries, offering product recommendations, and explaining medication instructions.
- Monitor stock levels, perform regular inventory checks, and reorder medications and supplies as necessary.
- Assist with processing insurance claims, billing, and maintaining accurate patient records.
Executive in Medical Writing
CliNovi Research
Pune, India
05.2023 - 05.2024
- Created and edited high-quality medical documents, including clinical study reports, regulatory submission documents (e.g., IND, NDA), and clinical trial protocols.
- Prepared regulatory submission documents for approval, ensuring compliance with global standards (FDA, EMA, ICH, etc.).
- Worked closely with physicians, subject matter experts (SMEs), and clinical research associates to gather, interpret, and present complex scientific data.
- Developed publication strategies, including the preparation of manuscripts for peer-reviewed journals and coordination with key opinion leaders (KOLs).
Junior Executive in Medical Writing
CliNovi Research
Pune, India
01.2022 - 01.2023
- Assisted in creating and editing medical documents, including clinical study reports, patient information leaflets, and regulatory submission documents.
- Supported the preparation of regulatory documents, including protocols, informed consent forms (ICFs), and investigator brochures, ensuring compliance with FDA, EMA, and ICH guidelines.
- Conducted literature searches to gather background information and clinical data for medical writing projects.
- Worked closely with senior medical writers, clinical research teams, and subject matter experts to gather information and ensure scientific accuracy in documents.
Research Associate Trainee
Curateq Biologics Pvt. Ltd.
Hyderabad, India
05.2021 - 12.2021
- Supported researchers in designing and implementing experiments, ensuring accuracy and consistency in data gathering.
- Analyzed data using statistical software (e.g., SPSS, R, Excel) and helped interpret results for reports and presentations.
- Documented experimental procedures, results, and observations in lab notebooks and electronic systems, adhering to regulatory standards.
- Gained experience in laboratory techniques such as PCR, gel electrophoresis, microscopy, and titration.
Pharmacy Assistant
HealthSmart Pharmacy
Melbourne, Australia
09.2019 - 02.2021
- Verify the accuracy of prescriptions, including checking for drug interactions, allergies, and contraindications.
- Educate patients on proper medication usage, potential side effects, and safety precautions.
- Assist with the organization and storage of medications, ensuring compliance with safety and regulatory standards.
- Maintain and organize pharmacy documentation and ensure compliance with healthcare regulations.
Education
Master of Science - Biotechnology
Swinburne University of Technology
Melbourne, Australia06-2020
Bachelor of Science - Pharmacy
Jawaharlal Nehru Technological University
Hyderabad, India06-2017
Skills
- Kroll Software
- Customer-Oriented
- Microsoft Office
- Data entry, Order Management
- Medical Writing
- PowerPoint Presentation
- Analytical Skills
- Research & Development
Certification
- GPAT (Graduate Pharmacy Aptitude Test) Certificate, INDIA
- S2 & S3 Community Pharmacy Certificate, AUSTRALIA
Timeline
Regulatory & Compliance Analyst II
Molloy Medical Arts Pharma INC
12.2024 - Current
Pharmacy Assistant
Parkdale Guardian Pharmacy
08.2024 - 12.2024
Executive in Medical Writing
CliNovi Research
05.2023 - 05.2024
Junior Executive in Medical Writing
CliNovi Research
01.2022 - 01.2023
Research Associate Trainee
Curateq Biologics Pvt. Ltd.
05.2021 - 12.2021
Pharmacy Assistant
HealthSmart Pharmacy
09.2019 - 02.2021
Master of Science - Biotechnology
Swinburne University of Technology
Bachelor of Science - Pharmacy
Jawaharlal Nehru Technological University