Job highlights

- B.Pharm/M.Pharm/Pharm.D or Life Sciences graduates with knowledge of MedDRA coding, ICSR processing, and Argus Safety
- Monitor and report AEs, SAEs, ADRs; perform medical coding, causality assessment, case narrative writing, and safety data validation ensuring regulatory compliance

Role & responsibilities Responsible for monitoring and reporting Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Drug Reactions (ADRs). Handle Individual Case Safety Report (ICSR) processing, medical coding using MedDRA, causality assessment, case narrative writing, and safety data validation. Ensure compliance with ICH-GCP, GVP, FDA, EMA, and other regulatory guidelines. Support literature screening, safety database management, follow-up activities, and quality checks.

Key Skills

Pharmacovigilance, Drug Safety, ICSR Processing, AE/SAE Reporting, ADR Monitoring, MedDRA Coding, Medical Terminology, Causality Assessment,



Argus Safety, ICH-GCP, GVP, and Regulatory Compliance.

Preferred candidate profile

- B.Pharm, M.Pharm, Pharm.D, B.Sc./M.Sc. Life Sciences, Biotechnology, Microbiology, Biochemistry, or Clinical Research graduates.
- Freshers and candidates with 02 years of experience in Pharmacovigilance or Drug Safety.
- Basic knowledge of AE/SAE reporting, ADR monitoring, ICSR processing, and medical terminology.
- Familiarity with ICH-GCP, GVP guidelines, and MedDRA coding is preferred.
- Knowledge of Oracle Argus Safety or other pharmacovigilance databases is an added advantage.
- Strong analytical, documentation, communication, and data management skills.
- Positive attention to detail and ability to meet reporting timelines.

📌 Pharmacovigilance Associate (Hyderabad)
🏢 Airvin Skills
📍 Hyderabad