Officer – ICSR (Pharmacovigilance Case Processing)
Location: Ahmedabad, India
Company: Lambda Therapeutic Research Ltd.
Salary Range: INR 3,00,000 – 5,00,000 per annum
Experience Required: Freshers / 0–1 year
Employment Type: Full-Time
About Lambda Therapeutic Research Ltd.
Lambda Therapeutic Research Ltd. is a globally recognized full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India. The organization provides comprehensive end-to-end clinical research and pharmacovigilance services to pharmaceutical, biotechnology, and generic drug companies worldwide. With operational facilities across Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK), and Warsaw (Poland), Lambda supports global drug development and regulatory compliance initiatives.
Key Responsibilities
Perform pharmacovigilance Individual Case Safety Report (ICSR) processing including duplicate search, case validation, and safety data assessment.
Conduct accurate data entry and perform drug coding, MedDRA coding, listedness evaluation, causality assessment, and expedited reporting in accordance with pharmacovigilance guidelines.
Prepare high-quality medical narratives and ensure complete case documentation following internal SOPs, Work Instructions, and global regulatory requirements.
Maintain and update pharmacovigilance documentation including SOPs, templates, training materials, and process guides.
Communicate urgent safety issues to the Line Manager and Qualified Person for Pharmacovigilance (QPPV) when necessary.
Ensure compliance with global pharmacovigilance regulations, quality standards, timelines, and data consistency.
Support training activities for new team members and contribute to knowledge sharing within the pharmacovigilance team.
Collaborate with the ICSR Team Leader to escalate complex safety cases or issues outside routine scope.
Assist in maintaining regulatory compliance by ensuring timely processing and submission of safety reports.
Provide pharmacovigilance support to internal teams, clients, and regulatory authorities when required.
Mentor junior staff and contribute to continuous improvement of pharmacovigilance processes.
Stay updated with global pharmacovigilance regulations and safety reporting requirements.
Assist in developing and updating SOPs for Lambda’s Pharmacovigilance department and client projects.
Perform additional responsibilities assigned by the Line Manager to support departmental and business objectives.
Experience Required
Freshers or candidates with up to 1 year of experience in Pharmacovigilance or Drug Safety.
Basic understanding of pharmacovigilance processes including ICSR processing, MedDRA coding, and regulatory safety reporting is preferred.
Educational Qualification
Bachelor’s Degree in Pharmacy, Life Sciences, or a related discipline.
Why Join Lambda Therapeutic Research
Opportunity to build a career in Pharmacovigilance and Drug Safety within a globally recognized CRO.
Exposure to international pharmacovigilance systems, regulatory standards, and clinical safety operations.
Professional growth through training, mentorship, and collaboration with experienced clinical research professionals.
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