Vrushali Sonawane
Laxmi Chock, Hinjawadi Phase-1, Pune
Summary
With a proven track record at Fortrea Scientific Private Limited, I excel in pharmacovigilance, mastering ARGUS and ARISG databases, and adhering to ICH guidelines. My analytical prowess and clear communication have enhanced drug safety processes, ensuring regulatory compliance and safeguarding patient health. Expert in MEDRA coding and medical writing, I thrive in collaborative settings, driving continuous improvement. Analytical professional with technical knowledge and critical thinking skills to thrive in data-driven environments. Tackles challenges with positivity and drive to overcome. Works great alone or with others and consistently exceeds expectations.
Overview
1
1
year of professional experience
1
1
Certification
Work History
SAFETY SCIENCE ANALYST
Fortrea scientific private limited
12.2023 - Current
- ARGUS DATABASE and ARISG DATABASE- I worked on ARGUS database as well as ARISG Database
- Handling case intake, processing, and safety reporting for adverse events
- This included ensuring accurate data entry, quality control, timely promoting to Next WF and compliance with regulatory requirements
- ICH GUIDELINE- I have a solid understanding of ICH guidelines, particularly those related to pharmacovigilance (ICH E2E), ensuring compliance in areas such as safety data management, risk assessment, and reporting of adverse events
- My knowledge supports adherence to international standards for drug safety and regulatory submissions
- MEDRA CODING- I accurately classified and coded adverse events, medical history, and drug indications
- This ensured consistent and standardized reporting in alignment with regulatory requirements
- DATA ENTRY and INLINE QUALITY REVIEWER- I have experience in data entry as well as case reviewer
- My responsibilities included verifying data accuracy and maintaining compliance with regulatory and quality standards
- Medical writing- I'm handy with medical writing for particular data given or from documents, this involved summarizing lengthy data in given character limit, with clear, concise, and medically accurate language for event reports
- Effectively contribute to the pharmacovigilance and drug safety processes by ensuring compliance with regulatory requirements and company standards
- The role involves the collection, assessment, and reporting of adverse events (AEs) from various sources, such as spontaneous reports, special scenarios, literature reviews, and legal cases
- The goal is to safeguard patient safety and mitigate potential risks associated with drug usage while adhering to global and local pharmacovigilance regulations
Education
Bachelor of Pharmacy - 68 %
MIT WPU School of Pharmacy
Pune08.2021
Diploma In Pharmacy - 65 %
Institute of Pharmacy
Faizpur06.2018
Skills
- Having a good knowledge of medical terminology
- Decision-making capabilities
- Continuous improvement mindset
- Being able to communicate clearly and concisely, both verbally and in writing
- Reviewing clinical data and drug safety reports
- Analytical and critical thinking
- Being able to work well with others
- Being precise when handling data and reporting
Certification
Post Graduation diploma in pharmacovigilance, 08/01/16 - 06/30/18
Languages
Marathi
First Language
English
Proficient (C2)
C2
Hindi
Advanced (C1)
C1
Timeline
SAFETY SCIENCE ANALYST
Fortrea scientific private limited
12.2023 - Current
Post Graduation diploma in pharmacovigilance, 08/01/16 - 06/30/18
Bachelor of Pharmacy - 68 %
MIT WPU School of Pharmacy
Diploma In Pharmacy - 65 %
Institute of Pharmacy
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