Job Title:  Officer - ICSR

ORGANISATIONAL OVERVIEW

Lambda Therapeutic Research is a Global full-service Clinical Research Organization (CRO) with its headquarters in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK) and Warsaw (Poland), we offer comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries.

JOB DETAILS

• Perform pharmacovigilance case processing, including duplicate search and validation.
• Complete data entry, drug coding, MedDRA coding, listedness, causality assessment, expediting assessment, and narrative writing for ICSRs in accordance with SOPs, WIs, and regulatory guidelines
• Prepare, revise, and review SOPs, Work Instructions, templates, guides, and training documents
• Communicate urgent safety issues promptly to the Line Manager and QPPV.
• Maintain professional communication standards and accurate records of internal and external correspondence.
• Ensure compliance with quality standards, procedures, regulations, timelines, and consistency as per local and global PV requirements.
• Deliver training sessions for new joiners and team members as required.
• Collaborate with the ICSR Team Leader to escalate issues beyond normal scope.
• Support the Group Leader in achieving 100% regulatory compliance for timely case processing.
• Provide pharmacovigilance advice to clients and colleagues as needed.
• Assist and mentor less experienced team members to enable them to fulfill their roles effectively.
• Stay updated on regulatory intelligence and implement changes as required.
• Assist in developing SOPs for Lambda’s Pharmacovigilance Department and clients.
• Communicate with clients and/or regulatory agencies when required.
• Perform any other tasks assigned by the Line Manager to meet business needs.

EXPERIENCE

Fresher

EDUCATIONAL QUALIFICATION

Bachelor’s degree in Life Sciences, Pharmacy, or related field.