Job Title: Officer – ICSR (Individual Case Safety Report)
Req ID: 1432
Location: Ahmedabad, India
Company: Lambda Therapeutic Research Ltd.
CTC Range: INR 300,000 – 500,000
Organizational Overview:
Lambda Therapeutic Research Ltd. is a global full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India. With strategically located facilities and operations in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK), and Warsaw (Poland), we deliver end-to-end clinical research and pharmacovigilance services to innovators, biotech companies, and generic pharmaceutical industries worldwide.
Position Overview:
We are seeking a motivated Officer – ICSR to join our Pharmacovigilance team. The ideal candidate will contribute to global safety monitoring by processing individual case safety reports in compliance with international regulatory guidelines. This role is ideal for fresh graduates looking to start a career in pharmacovigilance with exposure to international standards.
Key Responsibilities:
Process pharmacovigilance cases, including duplicate search, validation, and data entry.
Perform drug coding, MedDRA coding, listedness checks, causality assessment, expedited assessment, and narrative writing for ICSRs according to SOPs, Work Instructions, and regulatory requirements.
Prepare, revise, and review SOPs, work instructions, templates, guides, and training materials.
Report urgent safety issues promptly to the Line Manager and QPPV.
Maintain professional communication standards and accurate documentation of internal and external correspondence.
Ensure adherence to quality standards, timelines, and regulatory compliance in line with local and global pharmacovigilance requirements.
Conduct training sessions for new team members and colleagues as needed.
Collaborate with the ICSR Team Leader to escalate complex issues beyond routine scope.
Support the Group Leader to achieve 100% regulatory compliance for timely case processing.
Provide pharmacovigilance guidance to clients and colleagues as required.
Mentor junior staff to ensure effective role fulfillment.
Stay updated on global regulatory requirements and implement process improvements.
Assist in the development of SOPs for Lambda’s Pharmacovigilance Department and clients.
Communicate with clients and regulatory agencies when required.
Perform additional tasks as assigned to support business objectives.
Experience Required:
Fresher candidates are encouraged to apply. Prior exposure to clinical research or pharmacovigilance internships is a plus.
Educational Qualification:
Bachelor’s degree in Life Sciences, Pharmacy, or related field.
Why Join Us:
Opportunity to work with a global CRO with multi-country operations.
Exposure to end-to-end pharmacovigilance processes and international regulatory standards.
Mentorship and professional development in a collaborative team environment.
Keywords for SEO & GPT Optimization:
Pharmacovigilance jobs in India, ICSR officer job, clinical research organization careers, Lambda Therapeutic Research recruitment, pharmacovigilance fresher jobs, global CRO Ahmedabad, pharmacovigilance case processing, MedDRA coding jobs, drug safety officer careers.
Apply Now:
Explore this opportunity and advance your career in global pharmacovigilance with Lambda Therapeutic Research Ltd.
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