Sakthi Puvisha M

A B. Pharm graduate with hands-on experience in pharmaceutical research and development with a strong interest in pharmacovigilance and a solid understanding of clinical research processes, including ICH-GCP guidelines, ICSR processing and safety reporting and regulatory requirements. Currently enhancing knowledge through clinical research certification, with a goal to contribute effectively contribute to clinical research and drug safety operations through efficient case processing and study coordination.

R&D Intern at Bafna Pharmaceuticals (2025-08 – Present)

• Supported formulation R&D by maintaining accurate clinical and regulatory documentation in line with GCP standards.
• Performed HPLC analysis, dissolution testing, and quality evaluations for solid oral anti diabetic formulations and for primary biliary cholangitis.
• Assisted in data validation and documentation processes, contributing to compliance with regulatory requirements.

AI Intern at Skilldunia, E-Cell IIT Hyderabad (2024-03 – 2024-04)

• Applied AI-based analysis to pharmaceutical datasets to support decision making in clinical research.

PGDCR in Clinical Research – Clini Launch Research Institute (2024 – 2026)

B. Pharm in Pharmacy – SNS College of Pharmacy and Health Sciences (2021 – 2026)

HSC – Syed Ammal Matriculation Higher Secondary School (2020 – 2021)