Job Title:  Officer

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 quality review of processed ICSRs, ensuring compliance with SOPs, WIs, regulatory guidelines, and timelines.
• Verify duplicate search, data entry, drug coding, MedDRA coding, listedness, causality assessment, expediting assessment, and narrative quality.
• Ensure cases meet regulatory reporting standards and are ready for submission.
• Review and provide feedback on SOPs, WIs, templates, guides, and training documents.
• Communicate critical quality issues promptly to Line Manager and QPPV.Maintain professional communication standards and accurate documentation of review findings.
• Ensure adherence to quality, consistency, and compliance with global PV requirements.
• Deliver training and guidance to case processors and new joiners on quality standards.
• Collaborate with Team Leaders to escalate quality concerns and support resolution.
• Support Group Leader in achieving 100% regulatory compliance through timely and accurate reviews.
• Provide pharmacovigilance quality advice to clients and colleagues as needed.Mentor and assist less experienced team members to improve quality performance.
• Stay updated on regulatory changes and implement quality improvements accordingly.
• Assist in developing and revising quality-related SOPs and processes for Lambda’s PV Department and clients.
• Communicate with clients and/or regulatory agencies regarding quality matters when required.Perform any other tasks assigned by Line Manager to meet business needs.

EXPERIENCE

2–4 years of experience in pharmacovigilance case processing and quality review.Strong knowledge of ICH guidelines, GVP, and global PV regulations.Expertise in MedDRA coding, drug dictionaries, and safety databases (e.g., Argus, ARISg, Veeva).Excellent attention to detail, analytical skills, and ability to identify quality gaps.Strong written and verbal communication skills in English.

EDUCATIONAL QUALIFICATION

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