Officer - ICSR (Lambda Therapeutics)

1/7/20261 min read

Roles and Responsibilities

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.