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Lambda Therapeutic Research Ltd., a globally recognized full-service Clinical Research Organization (CRO), is hiring an Officer – Pharmacovigilance Quality at its Ahmedabad location. This opportunity is ideal for pharmacovigilance professionals with 2–4 years of experience in ICSR processing and quality review, looking to work in a regulated, global PV environment with strong exposure to ICH-GVP standards, MedDRA coding, and safety databases.
With operations across India, USA, Canada, and Europe, Lambda Therapeutic offers a strong platform for long-term career growth in drug safety and PV quality compliance.
📌 Job Overview
- Job Title: Officer – Pharmacovigilance Quality
- Req ID: 1487
- Location: Ahmedabad, Gujarat
- Company: Lambda Therapeutic Research Ltd.
- CTC: ₹3,00,000 – ₹6,00,000 per annum
- Experience Required: 2–4 years
- Industry: Pharmacovigilance / Clinical Research
🔍 Key Responsibilities
- Perform quality review of processed ICSRs in compliance with SOPs, WIs, timelines, and regulatory requirements
- Verify duplicate checks, data entry accuracy, MedDRA coding, drug coding, listedness, causality, narratives, and expediting decisions
- Ensure cases meet global regulatory reporting standards and are submission-ready
- Identify and escalate critical quality issues to Line Manager and QPPV
- Maintain accurate documentation of review findings and quality metrics
- Review, update, and provide feedback on PV SOPs, WIs, templates, and training materials
- Deliver quality training and mentoring to case processors and new joiners
- Support Team Leaders and Group Leaders to achieve 100% regulatory compliance
- Provide pharmacovigilance quality guidance to clients and internal stakeholders
- Stay updated with ICH, GVP, and global PV regulatory changes and implement improvements
🎓 Educational Qualifications
- Bachelor’s degree in:
- Pharmacy
- Life Sciences
- Nursing
- Or related discipline
💼 Experience & Skill Requirements
- 2–4 years of hands-on experience in pharmacovigilance case processing and quality review
- Strong working knowledge of:
- ICH Guidelines & GVP Modules
- MedDRA coding & drug dictionaries
- Safety databases such as Argus, ARISg, Veeva
- Excellent attention to detail and analytical ability
- Strong written and verbal communication skills in English
🌟 Why Join Lambda Therapeutic?
- Work with a global CRO handling international PV clients
- Exposure to end-to-end pharmacovigilance quality systems
- Strong emphasis on regulatory compliance and quality excellence
- Professional growth through training, mentoring, and global exposure
- Competitive salary aligned with industry standards