Officer – ICSR (Individual Case Safety Report Processing)
Location: Ahmedabad, India
Company: Lambda Therapeutic Research Ltd.
Industry: Clinical Research / Pharmacovigilance / Drug Safety
Employment Type: Full-Time
Experience Required: Freshers eligible
Compensation: INR 3,00,000 – 5,00,000 per annum
Organization Overview
Lambda Therapeutic Research is a global full-service Contract Research Organization (CRO) headquartered in Ahmedabad, India, providing comprehensive clinical research services to innovator, biotechnology, and generic pharmaceutical companies worldwide. With operational facilities across India, the United States, Canada, Spain, the United Kingdom, and Poland, the organization delivers end-to-end solutions across the clinical research lifecycle, supporting global drug development and regulatory compliance.
Job Overview
The Officer – ICSR role focuses on pharmacovigilance case processing and drug safety reporting activities. The position involves managing Individual Case Safety Reports (ICSRs), ensuring regulatory compliance, performing medical coding, and supporting pharmacovigilance operations. This entry-level opportunity is ideal for life sciences graduates seeking to build a career in pharmacovigilance, clinical safety, and regulatory compliance.
Key Responsibilities
Pharmacovigilance Case Processing
Perform end-to-end pharmacovigilance case processing, including duplicate search and validation.
Conduct data entry, drug coding, MedDRA coding, listedness evaluation, causality assessment, and expedited reporting assessments.
Prepare and develop narratives for Individual Case Safety Reports in accordance with SOPs, work instructions, and regulatory guidelines.
Regulatory Compliance and Documentation
Ensure adherence to global and local pharmacovigilance regulations, quality standards, and reporting timelines.
Prepare, review, and update Standard Operating Procedures (SOPs), work instructions, templates, and training documents.
Maintain accurate records of internal and external communications related to safety reporting.
Quality Assurance and Operational Support
Communicate urgent safety issues to Line Manager and Qualified Person for Pharmacovigilance (QPPV).
Support team leaders in achieving regulatory compliance and timely case processing targets.
Provide pharmacovigilance guidance to internal teams and external clients when required.
Training and Team Collaboration
Deliver training sessions for new team members and support knowledge transfer initiatives.
Assist and mentor junior staff to enhance performance and process understanding.
Collaborate with team leaders to escalate issues and support operational efficiency.
Regulatory Intelligence and Continuous Improvement
Stay updated with pharmacovigilance regulatory requirements and implement relevant updates.
Contribute to the development and enhancement of pharmacovigilance processes and documentation.
Support departmental and client-specific pharmacovigilance initiatives as required.
Educational Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, or a related discipline.
Experience Requirements
Freshers are eligible to apply.
Basic understanding of pharmacovigilance, drug safety, or clinical research processes is advantageous.
Required Skills and Competencies
Strong knowledge of medical terminology and pharmacovigilance concepts is preferred.
Attention to detail and ability to manage safety data accurately.
Good written and verbal communication skills.
Ability to work in a team-oriented and compliance-driven environment.
Strong analytical and documentation skills.
Career Growth Opportunities
Exposure to global pharmacovigilance processes and regulatory standards.
Professional development in drug safety operations and clinical research.
Opportunity to work within a global CRO environment supporting international pharmaceutical clients.
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