Officer

Lambda Research Accelerated

2-4 years

300000 - 600000

Ahmedabad India

10 Jan. 2, 2026

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ 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 (ICSR)
Location: Ahmedabad, India (Global CRO)
Employment Type: Full-Time
CTC Range: INR 3,00,000 – 6,00,000 per annum
Experience Required: 2–4 years

Company Overview

Lambda Therapeutic Research Ltd. is a leading global full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India, with strategic operations in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK), and Warsaw (Poland). We deliver end-to-end clinical research services to innovators, biotech firms, and generic pharmaceutical industries worldwide. Our mission is to accelerate drug development through high-quality, compliant, and timely clinical research services.

Role Overview

We are seeking an experienced Officer – Pharmacovigilance Quality Review to join our ICSR (Individual Case Safety Report) team. This role is critical to ensuring that safety data is accurately reviewed, meets global regulatory standards, and is ready for timely submission. The ideal candidate will have strong expertise in pharmacovigilance case processing, MedDRA coding, and regulatory compliance.

This position offers exposure to global pharmacovigilance practices, collaboration with cross-functional teams, and opportunities to contribute to process improvement initiatives.

Key Responsibilities

Perform quality review of processed ICSRs, ensuring adherence to SOPs, Work Instructions (WIs), regulatory guidelines, and timelines.
Verify duplicate search, data entry, drug coding, MedDRA coding, listedness, causality assessment, expedited assessment, and narrative quality.
Ensure all cases comply with regulatory reporting standards and are ready for submission to authorities.
Review and provide feedback on SOPs, WIs, templates, guides, and training materials.
Promptly communicate critical quality issues to Line Manager and QPPV.
Maintain professional documentation and accurate records of review findings.
Provide guidance and training to new joiners and case processors on quality standards and best practices.
Collaborate with Team Leaders to escalate and resolve quality concerns effectively.
Support the Group Leader in achieving 100% regulatory compliance through timely and accurate quality reviews.
Mentor and assist junior team members to strengthen quality performance.
Stay updated on global PV regulations and implement process improvements proactively.
Assist in developing and revising quality-related SOPs and workflows for Lambda’s PV Department and clients.
Communicate with clients and regulatory agencies regarding quality-related matters when necessary.

Experience & Qualifications

Experience: 2–4 years in pharmacovigilance case processing and quality review.
Proven knowledge of ICH guidelines, GVP, and global PV regulations.
Expertise in MedDRA coding, drug dictionaries, and safety databases (e.g., Argus, ARISg, Veeva).
Strong analytical skills with meticulous attention to detail and ability to identify quality gaps.
Excellent written and verbal communication skills in English.
Demonstrated ability to mentor junior team members and provide quality guidance.

Education:

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

Why Join Lambda Therapeutic Research?

Work with a global CRO delivering clinical research and pharmacovigilance services across multiple regions.
Exposure to international pharmacovigilance regulations and global drug safety practices.
Opportunity to enhance your career through process improvement, mentorship, and regulatory compliance initiatives.
Dynamic and collaborative work environment with a focus on professional growth and learning.
Competitive salary and benefits package aligned with industry standards.

Apply Today: Become part of Lambda Therapeutic Research’s mission to drive high-quality pharmacovigilance globally and advance your career in clinical research and drug safety.

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Officer

Job Description

Company Overview

Role Overview

Key Responsibilities

Experience & Qualifications

Why Join Lambda Therapeutic Research?

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