Amrutha S

About Amrutha S

Pharm.D professional with around 5 years of experience in Pharmacovigilance, specializing in quality review of Individual Case Safety Reports (ICSRs). Strong expertise in case QC, MedDRA coding validation, narrative review, and compliance with EMA, US FDA, and ICH guidelines. Proven ability to ensure data accuracy, regulatory compliance, and inspection readiness while meeting strict timelines.

Experience

1. Sr Drug Safety Associate

   Tata Consultancy Services

   Aug 2022 — Present

   Responsibilities include:• Performed comprehensive quality review (QC) of Individual Case Safety Reports (ICSRs) to ensure accuracy, completeness, and compliance with global regulatory requirements.• Reviewed and validated MedDRA coding (AEs, indications, medical history, lab data) and WHO-DD drug coding for consistency and regulatory adherence.• Conducted narrative review and medical consistency checks, ensuring clinical accuracy and clear case chronology.• Verified case seriousness, expectedness, causality, and reportability in accordance with EMA, US FDA, and ICH (E2B) guidelines.• Ensured adherence to global regulatory timelines for expedited and non-expedited cases (serious, non-serious, SUSARs).• Ensured proper handling of duplicate cases, nullification, downgrades, and case versioning per regulatory guidance.• Reviewed follow-up strategy and adequacy, ensuring compliance with health authority expectations.• Maintained strict confidentiality and data integrity in accordance with pharmacovigilance and data protection standards.• Performed case reconciliation support activities to ensure alignment between safety databases and regulatory submissions.• Collaborated with cross-functional teams (medical, regulatory, operations) to resolve complex case issues.• Identified, documented, and resolved data discrepancies and quality issues, providing feedback to case processors and contributing to CAPA activities.• Performed peer reviews and second-level QC, contributing to continuous quality improvement initiatives.• Ensured compliance with SOPs, Work Instructions, and client-specific requirements.• Participated in process improvement activities, quality trend analysis, and training of junior team members.

Education

• QIS College of Pharmacy

  Doctor of Pharmacy, Pharm.D

  2014 — 2020

• Vikas

  High School Diploma

• Sri Gayatri junior college

  Intermediate (BiPC)