Lambda Therapeutic Research Ltd. Hiring For Officer - ICSR

Responsibilities

• Perform pharmacovigilance case processing activities for Individual Case Safety Reports (ICSRs).
• Conduct duplicate search and validation for adverse event cases.
• Perform data entry and safety data management in pharmacovigilance databases.
• Carry out drug coding and MedDRA coding according to regulatory standards.
• Assess listedness, causality, and seriousness of adverse events.
• Perform expedited reporting assessment and ensure timely submissions.
• Write and review medical narratives for ICSRs as per SOPs and regulatory guidelines.
• Ensure compliance with global pharmacovigilance regulations and company SOPs.
• Communicate urgent safety issues to the Line Manager and QPPV promptly.
• Assist in preparation and revision of SOPs, work instructions, and training documents.
• Support training activities for new joiners and pharmacovigilance team members.
• Collaborate with team leaders to escalate issues related to case processing.
• Maintain accurate documentation and records of pharmacovigilance activities.
• Provide pharmacovigilance support and guidance to clients and internal teams.

Skills

• Pharmacovigilance
• ICSR Case Processing
• Adverse Event Reporting
• MedDRA Coding
• Drug Safety
• Pharmacovigilance Databases
• Regulatory Compliance
• Clinical Data Management
• Medical Narrative Writing
• Quality Documentation
• Attention to Detail
• Communication Skills

Company Overview

Lambda Therapeutic Research Ltd. is a global full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India. The company provides comprehensive clinical research services including bioequivalence studies, pharmacovigilance, clinical trials, and regulatory support to pharmaceutical, biotech, and generic drug companies worldwide. Lambda has global operations across India, USA, Canada, Spain, UK, and Poland.

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