Officer ICSR (Pharmacovigilance)

Roles & Responsibilities:

• End-to-end processing of ICSR cases in compliance with global PV regulations
• Perform duplicate checks, case validation, data entry, and drug/MedDRA coding
• Conduct listedness, causality, and expediting assessments
• Prepare high-quality case narratives and ensure timely submissions
• Ensure adherence to SOPs, work instructions, and regulatory requirements
• Communicate urgent safety issues to Line Manager/QPPV
• Maintain accurate documentation and professional communication
• Support SOP, WI, template development, and team training
• Provide PV guidance to internal teams and clients
• Stay updated with regulatory intelligence and implement changes

Qualification:

• Bachelor’s degree in Pharmacy (B.Pharm), Life Sciences, Biotechnology, Clinical Research, or related discipline

Experience:

• Freshers eligible
• Basic knowledge of Pharmacovigilance, MedDRA, and ICSR lifecycle is an advantage

Skills:

• Understanding of PV concepts and global safety regulations
• Attention to detail and data accuracy
• Good written and verbal communication skills
• Ability to meet timelines and work in a regulated environment

About the Company:

Lambda Therapeutic Research Ltd. is a globally recognized Contract Research Organization (CRO) offering comprehensive clinical research and pharmacovigilance services, providing strong career growth opportunities in drug safety and regulatory compliance.

How to Apply?
Application Link