Headline

Safety Science Analyst | End-to-End ICSR Processing & SAE Reporting | Pharmacovigilance @ Fortrea

About

Every drug on the market has a safety story behind it. I'm one of the people who documents it. As a Safety Science Analyst at Fortrea, I manage the end-to-end lifecycle of Individual Case Safety Reports (ICSRs) — from intake and data entry through narrative writing, quality review. I handle spontaneous case processing, SAE and adverse event reporting, follow-up management, and case nullification, working within strict global pharmacovigilance timelines and ICH E2B standards. In my first year, I've built a working knowledge of the full PV workflow: triaging incoming safety data, applying medical judgment to case narratives, and maintaining data integrity through quality review cycles. I understand what it takes to keep a safety database clean and a regulatory dossier defensible. My background in pharmacy gives me the clinical foundation to assess cases accurately — not just process them. That difference matters when a regulator asks questions. 📌 If you're hiring for pharmacovigilance roles — ICSR processing, safety reporting, or drug safety operations — let's talk. Open to opportunities across India and globally.

Location

Greater Chennai Area

Work experience

safety science analyst at Fortrea, Jul 2025 - Jun 2026 · 1 yr, Bengaluru, Karnataka, India, Safety Science Analyst · Fortrea • Ensured zero late submissions on ICSR cases by managing end-to-end case processing — from intake through narrative writing and quality review — within regulatory reporting windows. • Maintained data accuracy across a high-volume spontaneous case processing workflow by applying ICH E2B standards and conducting systematic quality checks, reducing rework on case records. • Strengthened regulatory defensibility of safety narratives by applying clinical pharmacy knowledge to accurately characterise adverse events, resulting in cleaner, audit-ready case documentation. • Managed follow-up outreach and case nullification/deletion requests across multiple safety databases, ensuring case lifecycle completeness and database integrity for regulatory submissions. • Supported cross-functional safety data review by coordinating workflow management tasks and flagging signal-relevant cases for pharmacovigilance scientists, contributing to team efficiency in case triage.

Pharmaceutical Production Technician at Sai Mirra Innopharm, Sep 2024 - Oct 2024 · 2 mos, Ambattur, Tamil Nadu, India

Pharmacist at Sri kumaran pharmacy, Aug 2024 - Oct 2024 · 3 mos, Āvadi, Tamil Nadu, India

Education

Bachelor of Pharmacy - BPharm, Pharmacy, Jaya College Of Pharmacy

Mathematical Biology, Kanchi sri sankara academy matric Hr. Sec. School