Lambda Therapeutic Research Ltd., a globally recognized Clinical Research Organization (CRO), is inviting applications for the position of 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 who are looking to advance their career in a global CRO environment.

With operations across India, the USA, Canada, and Europe, Lambda Therapeutic Research offers exposure to global pharmacovigilance regulations, ICH-GCP, and GVP standards, making this role highly valuable for long-term PV career growth.

🧪 Key Responsibilities – Pharmacovigilance Officer (Quality)

• Perform quality review of processed ICSRs ensuring compliance with SOPs, WIs, timelines, and global PV regulations
• Verify duplicate checks, data entry accuracy, MedDRA coding, drug coding, listedness, causality, and narratives
• Ensure cases meet regulatory reporting standards and are submission-ready
• Review and provide feedback on SOPs, WIs, templates, training materials, and guides
• Communicate critical quality issues to Line Manager and QPPV in a timely manner
• Maintain accurate documentation and professional communication standards
• Deliver training and guidance to case processors and new joiners
• Collaborate with Team Leaders to escalate and resolve quality concerns
• Support Group Leaders to achieve 100% regulatory compliance
• Provide pharmacovigilance quality advice to clients and internal teams
• Mentor junior team members and support continuous quality improvement
• Stay updated with ICH, GVP, and global PV regulatory changes
• Assist in development and revision of quality-related SOPs and PV processes
• Communicate with clients and regulatory agencies on quality matters when required

🎓 Qualifications & Experience Required

Educational Qualification

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related discipline

Experience & Skills

• 2–4 years of experience in pharmacovigilance case processing and quality review
• Strong knowledge of ICH guidelines, GVP modules, and global PV regulations
• Hands-on expertise in MedDRA coding, drug dictionaries, and safety databases such as:
  • Oracle Argus
  • ARISg
  • Veeva Safety
• Excellent attention to detail, analytical thinking, and quality gap identification
• Strong written and verbal communication skills in English

💼 Salary & Benefits

• CTC Range: ₹3,00,000 – ₹6,00,000 per annum
• Opportunity to work with a global CRO
• Exposure to international pharmacovigilance clients and regulatory agencies
• Structured training and career progression
• Professional work environment with strong quality culture

📍 Job Location

Ahmedabad, Gujarat, India

📝 How to Apply

Application Link