Subramani S

About Subramani S

Pharmacovigilance professional with over 3+ years of experience in drug safety operations, specializing in Individual Case Safety Report (ICSR) processing, adverse event evaluation, and regulatory compliance aligned with ICH-GVP guidelines.Currently working as a Drug Safety Associate at Accenture, contributing to global pharmacovigilance activities including case triage, MedDRA coding, safety narrative writing, and adherence to worldwide regulatory reporting timelines.Experienced across multiple therapeutic areas including Oncology, Central Nervous System, Cardiovascular, Rheumatology, and Immunology.Core strengths include data accuracy, quality compliance, analytical thinking, and cross-functional collaboration to ensure patient safety and regulatory excellence.Open to opportunities in Pharmacovigilance, Drug Safety Operations, and Clinical Safety roles.

Experience

1. Drug Safety Associate

   Accenture

   Mar 2025 — Present · Chennai, IN

   Perform end-to-end processing of ICSRs every day from spontaneous, literature, and partner sources in compliance with global pharmacovigilance standards.Conduct case triage, validity assessment, and duplicate searches ensuring >98% data quality accuracy.Evaluate seriousness, expectedness, and causality following ICH-GVP guidelines.Execute accurate MedDRA coding for adverse events, indications, and medical history.Develop medically coherent safety narratives supporting global regulatory submissions.Ensure adherence to expedited reporting timelines for global health authorities.Utilize LifeSphere MultiVigilance AI platform for case processing and workflow management.Collaborate with cross-functional global teams to resolve safety data discrepancies.

Education

• Kaligi Ranganathan Montford matriculation higher secondary school.

  Hslc

• VELS University

  Master's degree, Pharmaceutical Sciences

• VELS University

  Bachelor of Pharmacy - BPharm, Pharmacy