Job Title: Officer – ICSR (Pharmacovigilance)
Company: Lambda Therapeutic Research Ltd.
Location: Ahmedabad, India
Job Type: Full-Time
Experience Required: Freshers / Entry-Level
Salary Range: INR 3,00,000 – 5,00,000 per annum
Job ID: 1432
About Lambda Therapeutic Research Ltd.
Lambda Therapeutic Research Ltd. is a global full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India. The company provides comprehensive end-to-end clinical research solutions for global pharmaceutical, biotechnology, and generic drug companies. Lambda operates internationally with facilities in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK), and Warsaw (Poland). The organization is known for delivering high-quality clinical research, pharmacovigilance, and regulatory services that support drug development and patient safety worldwide.
Role Overview
Lambda Therapeutic Research Ltd. is hiring an Officer – ICSR to support pharmacovigilance operations and individual case safety report (ICSR) processing. This entry-level position is suitable for fresh graduates who want to build a career in drug safety, pharmacovigilance, and clinical research. The selected candidate will be responsible for processing safety cases, ensuring regulatory compliance, and supporting pharmacovigilance documentation according to global regulatory standards.
Key Responsibilities
ICSR Case Processing and Drug Safety Monitoring
Perform pharmacovigilance case processing activities including duplicate searches and case validation.
Conduct accurate data entry for Individual Case Safety Reports (ICSRs) within pharmacovigilance databases.
Perform drug coding and MedDRA coding as per global pharmacovigilance standards.
Conduct listedness assessment, causality evaluation, and expedited reporting assessments.
Prepare and maintain high-quality safety narratives for adverse event reports.
Compliance and Regulatory Documentation
Ensure case processing is performed according to Standard Operating Procedures (SOPs), Work Instructions (WIs), and global regulatory guidelines.
Maintain compliance with pharmacovigilance quality standards, timelines, and regulatory requirements.
Monitor regulatory updates and implement necessary changes in safety reporting processes.
Quality Management and Documentation Development
Prepare, revise, and review SOPs, templates, training documents, and pharmacovigilance guidance materials.
Assist in the development of internal pharmacovigilance procedures for Lambda and client projects.
Communication and Collaboration
Communicate urgent safety issues promptly to the Line Manager and Qualified Person for Pharmacovigilance (QPPV).
Maintain professional communication with internal teams, clients, and regulatory authorities when required.
Work closely with the ICSR Team Leader to escalate issues that fall outside routine case processing activities.
Support the Group Leader to ensure 100 percent regulatory compliance in case processing timelines.
Training and Knowledge Sharing
Deliver training sessions for new team members and assist with onboarding activities.
Provide mentorship and guidance to less experienced colleagues to strengthen team performance.
Additional Responsibilities
Provide pharmacovigilance support and guidance to internal teams and clients when necessary.
Assist with regulatory communications and safety reporting requirements.
Perform additional tasks assigned by the Line Manager to support business and project needs.
Experience Requirements
Freshers or entry-level candidates with academic knowledge of pharmacovigilance, drug safety, or clinical research are encouraged to apply.
Educational Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, or a related discipline.
Skills and Competencies
Basic understanding of pharmacovigilance and drug safety principles.
Familiarity with MedDRA coding and ICSR processing concepts is an advantage.
Strong attention to detail and documentation accuracy.
Good communication and collaboration skills.
Ability to work in a structured and compliance-driven environment.
Work Location
Ahmedabad, India.
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Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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