Officer - ICSR

Roles & Responsibilities
• Perform pharmacovigilance case processing including duplicate search and case validation
• Conduct data entry, drug coding, MedDRA coding, listedness, causality & expediting assessment
• Write and review ICSR narratives as per SOPs and regulatory guidelines
• Ensure timely and compliant submission of safety cases as per local & global PV requirements
• Communicate urgent safety issues to Line Manager and QPPV
• Maintain accurate documentation and professional internal/external correspondence
• Support preparation and revision of SOPs, WIs, templates, and training materials
• Provide training to new joiners and mentor junior team members
• Collaborate with Team Leader/Group Leader to ensure 100% regulatory compliance
• Stay updated with regulatory intelligence and implement required changes
• Liaise with clients and regulatory authorities when required

Qualification
• Bachelor’s degree in Life Sciences, Pharmacy, or related field

Experience
• Freshers eligible

Skills
• Knowledge of pharmacovigilance and ICSR processing
• Understanding of MedDRA coding and safety databases
• Awareness of global PV regulations and compliance standards
• Strong documentation and narrative writing skills
• Good communication and teamwork abilities
• Attention to detail and ability to meet strict timelines

About the Organization
Lambda Therapeutic Research is a global full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India, with operations across India, USA, Canada, UK, Spain, and Poland. The company provides end-to-end clinical research and pharmacovigilance services to global pharmaceutical and biotech industries.