B. Pharmacy graduate with certification-based training in pharmacovigilance, ICSR processing, and MedDRA medical terminologies and hierarchy.
Gained exposure to regulatory practices including GCP and ICH guidelines through internship at Unichem Laboratories.
Developed and evaluated a natural polymer-based mouth ulcer gel during final year project work.
Holds basic understanding of Argus Safety software and its application in case processing.
Detail-oriented, motivated, and eager to contribute to drug safety and regulatory operations in entry-level PV or MedDRA coding roles.
Hardworking Student offering part-time work experience and extensive knowledge of core subject matter. Meticulous and detail-oriented with excellent observational, organizational and communication skills.
Overview
1
1
Certification
Work History
Intern - Process Development Lab
Unichem Laboratories Ltd.
07.2024 - 12.2024
Reviewed SOPs related to Good Clinical Practice (GCP) and ICH regulatory guidelines
Gained awareness of documentation standards followed in pharmaceutical safety and compliance
Understood the structure and purpose of safety-related documents used in pharmacovigilance
Developed attention to detail and understanding of technical documentation in regulatory environments.
Education
Bachelor of Pharmacy -
Raigad College of Pharmacy , Mohopre
Mahad Raigad
07-2025
Skills
Understanding on Pharmacovigilance Fundamental(ICSR , AE reporting )
MedDRA coding (LLT to SOC Mapping )
Application of MedDRA in ICSR case processing
GCP (Good Clinical Practices ) and ICH guidelines awareness
Basic understanding about medical terminologies and PV workflow
Microsoft Excel and Microsoft Word
Attention to Detail and Data Accuracy
Strong Communication and Scientific Writing Skill
Certification
MedDRA Coding Basics Webinar by MSSO
MedDRA Training Certificate Course , Udemy
Certificate Course in "Pharmacovigilance Practical ICSR " ,Udemy