Officer – ICSR (Individual Case Safety Report)
Location: Ahmedabad, India
Company: Lambda Therapeutic Research Ltd.
Employment Type: Full-Time
Experience Required: Fresher / Entry-Level
CTC Range: INR 3,00,000 – 5,00,000
About Lambda Therapeutic Research
Lambda Therapeutic Research Ltd. is a global, full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India. With strategic operations in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK), and Warsaw (Poland), Lambda provides end-to-end clinical research services to innovator, biotech, and generic pharmaceutical companies worldwide.
Our mission is to deliver high-quality, compliant, and timely clinical research solutions that accelerate drug development and improve patient safety globally.
Position Overview
As an Officer – ICSR, you will be responsible for processing pharmacovigilance cases, ensuring accuracy, compliance, and timely reporting. This entry-level position is ideal for fresh graduates in Life Sciences, Pharmacy, or related fields who are looking to start a career in drug safety and pharmacovigilance. You will gain hands-on experience in global regulatory compliance, data management, and safety reporting while working in a dynamic and supportive team environment.
Key Responsibilities
Perform ICSR case processing including duplicate check, validation, and case entry.
Complete drug coding, MedDRA coding, listedness check, causality assessment, expedited reporting, and narrative writing in compliance with SOPs, WIs, and regulatory guidelines.
Prepare, revise, and review SOPs, work instructions, templates, guides, and training materials.
Communicate urgent safety issues promptly to the Line Manager and QPPV.
Maintain professional communication and accurate records of internal and external correspondence.
Ensure compliance with quality standards, procedures, timelines, and regulatory requirements both locally and globally.
Deliver training sessions for new joiners and team members as required.
Collaborate with the ICSR Team Leader to escalate issues beyond standard scope.
Support the Group Leader in achieving 100% regulatory compliance for case processing.
Provide pharmacovigilance guidance to colleagues and clients as needed.
Assist and mentor junior team members, ensuring effective role execution.
Stay updated on regulatory intelligence and implement procedural changes accordingly.
Assist in developing SOPs for Lambda’s Pharmacovigilance Department and clients.
Communicate with clients and regulatory authorities when required.
Perform additional tasks assigned by the Line Manager to meet business objectives.
Educational Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, or related field.
Experience
Fresher / Entry-Level candidates are eligible.
Candidates with prior exposure to pharmacovigilance or clinical research internships will have an added advantage.
Skills & Competencies
Strong attention to detail and accuracy in data handling.
Good written and verbal communication skills.
Ability to work independently and as part of a team.
Knowledge of pharmacovigilance processes, drug safety regulations, and MedDRA coding is desirable.
Strong organizational and time management skills.
Willingness to learn and adapt to global regulatory standards.
Why Join Lambda Therapeutic Research?
Gain hands-on experience in pharmacovigilance and drug safety at a global CRO.
Exposure to international regulatory standards and reporting requirements.
Structured mentorship and learning opportunities for career growth.
Dynamic and collaborative work environment fostering professional development.
Competitive salary and benefits package.
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