Officer ICSR - Pharmacovigilance

Role & Responsibilities
• Perform ICSR processing: duplicate search, validation, data entry, drug/MedDRA coding
• Conduct listedness, causality, and expedited reporting assessments
• Write clear, accurate narratives for ICSRs
• Prepare, revise, and review SOPs, work instructions, and training materials
• Report urgent safety issues promptly to Line Manager and QPPV
• Maintain professional communication and accurate correspondence records
• Ensure 100% regulatory compliance and timely case processing
• Deliver training to new joiners and support team members
• Stay updated on regulatory intelligence and implement changes
• Provide PV advice to clients/colleagues and communicate with agencies as needed
• Assist in SOP development and perform assigned tasks

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

Experience
• Fresher (Entry-level position)

Skills
• Strong understanding of pharmacovigilance basics (preferred but not mandatory for freshers)
• Proficiency in data entry, medical terminology, and attention to detail
• Knowledge of MedDRA coding, causality assessment, and regulatory guidelines (trainable)
• Excellent written and verbal communication skills
• Ability to work with timelines, maintain records, and ensure compliance
• Team player with eagerness to learn and mentor others

About the Company
Lambda Therapeutic Research is a leading full-service Global Clinical Research Organization (CRO) headquartered in Ahmedabad, India. Founded in 1998, it provides comprehensive end-to-end clinical research services to innovator, biotech, and generic pharmaceutical industries worldwide. With strategic facilities in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK), and Warsaw (Poland), Lambda excels in BA/BE studies, bioanalytical services, clinical trials (Phase I-IV), pharmacovigilance, medical imaging, biostatistics, data management, and more.