Job Title: Officer – ICSR (Individual Case Safety Report)
Job Category: Pharmacovigilance / Drug Safety / Clinical Research
Job Type: Full-Time
Experience Level: Fresher / Entry-Level
Location: Ahmedabad, Gujarat, India
Req ID: 1432
CTC Range: INR 3,00,000 – 5,00,000 per annum
Company Overview
Lambda Therapeutic Research Ltd. is a global full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India. The organization provides end-to-end clinical research and pharmacovigilance solutions to innovator, biotech, and generic pharmaceutical companies worldwide.
With operations across India, North America, and Europe, Lambda ensures compliance with international regulatory standards and delivers high-quality clinical and safety data to support global drug development programs.
Role Overview
We are looking for an Officer – ICSR to join our Pharmacovigilance team and support Individual Case Safety Report processing. The role is ideal for fresh graduates in Life Sciences, Pharmacy, or related fields who are looking to start a career in drug safety and pharmacovigilance.
This position plays a critical role in ensuring timely and accurate reporting of adverse events, maintaining regulatory compliance, and supporting the safety of patients globally.
Key Responsibilities
Process pharmacovigilance cases, including duplicate search, validation, and data entry for ICSRs.
Perform drug coding, MedDRA coding, listedness checks, causality assessment, expedited reporting, and narrative writing in accordance with SOPs, Work Instructions, and regulatory guidelines.
Prepare, review, and update SOPs, Work Instructions, templates, and training documents.
Communicate urgent safety issues promptly to Line Manager and Qualified Person for Pharmacovigilance (QPPV).
Maintain accurate records of internal and external correspondence while ensuring professional communication standards.
Ensure compliance with quality standards, procedures, regulatory timelines, and global PV requirements.
Deliver training sessions for new joiners and junior team members as required.
Collaborate with ICSR Team Leader to escalate complex or urgent issues beyond normal scope.
Assist the Group Leader in achieving 100% regulatory compliance for timely case processing.
Provide pharmacovigilance guidance to colleagues and clients as needed.
Mentor less experienced team members to enhance team performance and compliance.
Stay updated with regulatory intelligence and implement process changes as required.
Assist in developing and maintaining SOPs for Lambda’s Pharmacovigilance Department and clients.
Liaise with clients and regulatory agencies when required.
Perform other responsibilities as assigned by the Line Manager to support business needs.
Required Experience
Fresher or entry-level candidates with an interest in pharmacovigilance and drug safety.
Strong attention to detail, good communication skills, and ability to work in a team-oriented environment.
Educational Qualification
Bachelor’s degree in Life Sciences, Pharmacy, or related discipline.
Candidates looking to start their career in global pharmacovigilance and drug safety are encouraged to apply through ThePharmaDaily.com for confidential consideration.
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