Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

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
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
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
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
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.
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
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, Australia
06-2020

Bachelor of Science - Pharmacy

Jawaharlal Nehru Technological University
Hyderabad, India
06-2017

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

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