Headline

Safety Science Analyst at Fortrea

About

Pharmacovigilance professional with experience in ICSR case processing, MedDRA coding and seriousness & causality assessment. Strong knowledge of ICH guidelines and global safety regulations. Committed to ensuring patient safety, regulatory compliance and high-quality case management within timelines.

Location

Pune/Pimpri-Chinchwad Area

Work experience

Safety Science Analyst at Fortrea, Jul 2025 - Present · 11 mos, Supporting global pharmacovigilance operations by performing case processing, safety data review, and regulatory reporting. Ensuring compliance with global safety standards while contributing to signal detection and risk management activities in clinical and post-marketing settings.

Research Intern at Zenvision Pharma LLP, Jan 2025 - Apr 2025 · 4 mos, Assisted in analytical method development and validation for drug substances. Hands-on experience with HPLC, UV-Vis Spectroscopy and Dissolution Apparatus. Maintained lab records, SOPs and regulatory compliance documentation. Supported stability studies and impurity profiling as per ICH guidelines. Performed instrument calibration and troubleshooting.

Education

M. Pharmacy in Pharmaceutical Quality Assurance, Sinhgad Technical Education society's Sinhgad Institute of Pharmacy, Narhe, Pune- 411041

Bachelor of Pharmacy - BPharm, Vishal Junnar Seva Mandals Vishal Institute of Pharmaceutical Education & Research , Ale,Tal. Junnar,Dist.Pune 412411