Pharmacovigilance Officer Jobs in Coimbatore Pharmaceutical Company

📋 Job Description

Jobzi is sourcing qualified candidates for Pharmacovigilance Officer positions in Coimbatore's private Pharmaceutical Company sector. This is a full-time opportunity with a reputed Pharmaceutical and Life Sciences employer in Coimbatore offering competitive salary, structured growth, and a professional work environment. Tamil communication skills are preferred alongside English for professional and business interaction in Coimbatore.

📌 Key Responsibilities

• Process Individual Case Safety Reports (ICSRs) for adverse events received from clinical trials and post-marketing sources
• Code adverse event terms using MedDRA dictionary to appropriate System Organ Class and Preferred Terms
• Write accurate and concise medical narratives for ICSRs submitted to health authorities
• Perform literature search and screen publications for potential adverse event cases
• Conduct signal detection activities and prepare signal evaluation reports for review
• Ensure timely submission of ICSRs to CDSCO, FDA, EMA, and other health authorities within regulatory timelines
• Maintain pharmacovigilance databases (Argus, ARISg, Empirica) with accurate case data

🎓 Qualifications and Requirements

• B.Pharm, M.Pharm, M.Sc Life Sciences, MBBS, or BDS from a recognized institution
• 1 - 5 Years of pharmacovigilance or drug safety experience in a pharma company or CRO
• Knowledge of ICH E2A/E2B/E2C guidelines and MedDRA coding conventions
• Experience with PV database systems such as Argus Safety, ARISg, or Oracle Empirica
• Understanding of CDSCO, FDA, and EMA adverse event reporting requirements
• Good medical writing skills for ICSR narrative preparation
• ICH GCP certification or ISoP membership preferred
• Good Tamil and English communication skills for team coordination and client interaction in Coimbatore.

✅ Required Skills

🏆 Certifications and Qualifications

B.Pharm, M.Pharm, M.Sc Life Sciences, MBBS, BDS, Ph.D. in Pharmaceutical Sciences, ICH GCP certification, Drug Safety certification (ISoP), CCRP (Clinical Research), RAPS certification (Regulatory Affairs)