Job highlights

- Bachelor's or Master's in Life Sciences or related fields with knowledge of Pharmacovigilance and MedDRA coding
- Process and review ICSRs, perform AE/SAE/ADR reporting, medical coding, causality assessment, case narrative writing, and ensure regulatory compliance

Role & responsibilities Responsible for processing and reviewing Individual Case Safety Reports (ICSRs), monitoring and documenting Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Drug Reactions (ADRs). Perform case data entry, medical coding using MedDRA and WHO Drug Dictionary, causality assessment, case narrative writing, and safety data validation. Ensure accurate and timely reporting in compliance with ICH-GCP, Positive Pharmacovigilance Practices (GVP), FDA, EMA, and other regulatory guidelines.

Support literature screening, follow-up management, quality checks, and pharmacovigilance documentation.





Key Skills

Pharmacovigilance, Drug Safety, ICSR Processing, AE/SAE Reporting, ADR Assessment, MedDRA Coding, Medical Terminology, Argus Safety, Case Narrative Writing, Causality Assessment, Regulatory Compliance, and Data Management.

Preferred candidate profile

Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, Microbiology, Biochemistry, or Clinical Research.

Freshers and candidates with 02 years of experience in Pharmacovigilance or Clinical Research can apply.

Basic understanding of Pharmacovigilance, Drug Safety, AE/SAE reporting, and ADR monitoring.

Knowledge of medical terminology, ICH-GCP guidelines, and regulatory requirements is preferred.

📌 Drug Safety Associate (Kochi)
🏢 Airvin Skills
📍 Kochi