Officer

Lambda Therapeutic Research

2-4 years

300000 - 600000

Ahmedabad

10 Jan. 19, 2026

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Officer – Pharmacovigilance Quality Review
Req ID: 1487
Date: January 19, 2026
Location: Ahmedabad, India
Company: Lambda Therapeutic Research Ltd.
CTC Range (INR): 300,000 – 600,000

About Lambda Therapeutic Research Ltd.

Lambda Therapeutic Research Ltd. is a leading global full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India. With strategically located facilities in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK), and Warsaw (Poland), we provide end-to-end clinical research solutions to global innovators, biotech companies, and pharmaceutical organizations.

We are committed to maintaining the highest standards in pharmacovigilance, clinical research, and regulatory compliance while supporting the development of safe and effective therapeutics worldwide.

Role Overview

We are seeking a detail-oriented Officer – Pharmacovigilance Quality Review to ensure accurate and compliant processing of Individual Case Safety Reports (ICSRs). The ideal candidate will have hands-on experience in pharmacovigilance case processing, quality review, and regulatory compliance, with a strong understanding of global safety standards.

Key Responsibilities

Perform comprehensive quality review of processed ICSRs, ensuring compliance with SOPs, Work Instructions (WIs), global regulatory guidelines, and timelines.
Verify duplicate search, data entry, drug coding, MedDRA coding, listedness, causality assessment, expedited reporting, and narrative quality.
Ensure ICSRs meet regulatory reporting standards and are submission-ready.
Review and provide feedback on SOPs, WIs, templates, guides, and training documents.
Communicate critical quality issues promptly to the Line Manager and QPPV.
Maintain professional communication and accurate documentation of review findings.
Ensure adherence to quality, consistency, and global pharmacovigilance standards.
Deliver training and guidance to case processors and new joiners on quality expectations.
Collaborate with Team Leaders to escalate quality concerns and support issue resolution.
Support the Group Leader in achieving 100% regulatory compliance through timely and accurate ICSR reviews.
Provide pharmacovigilance quality advice to colleagues and clients as required.
Mentor junior team members to enhance quality performance and compliance awareness.
Stay updated on global regulatory changes and implement continuous quality improvements.
Assist in developing and revising quality-related SOPs and processes for Lambda’s PV Department and clients.
Communicate with clients and regulatory authorities regarding quality matters when necessary.
Perform additional tasks as assigned by the Line Manager to support business operations.

Experience Required

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

Educational Qualifications

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

Why Join Lambda Therapeutic Research?

Opportunity to work in a global CRO with exposure to international pharmacovigilance standards.
Hands-on experience in ICSR quality review and regulatory compliance.
Career growth through mentorship, training, and exposure to global pharmacovigilance operations.

Apply Now at The Pharma Daily to advance your career in pharmacovigilance and join a team driving excellence in global drug safety.

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Officer

Job Description

About Lambda Therapeutic Research Ltd.

Role Overview

Key Responsibilities

Experience Required

Educational Qualifications

Why Join Lambda Therapeutic Research?

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