Officer Pharmacovigilance Job at Lambda Therapeutic Research
The Officer position at Lambda Therapeutic Research Ltd. offers a strong opportunity for pharmacovigilance professionals to work in quality review and regulatory compliance within a global CRO environment. Based in Ahmedabad, this Officer Job role focuses on ensuring high-quality ICSR processing, adherence to global PV regulations, and continuous quality improvement. Graduates seeking B pharma jobs or Pharmacy jobs can apply now.
Job Details
- Job Title: Officer
- Location: Ahmedabad, India
About the Company
Lambda Therapeutic Research Ltd. is a global full-service Clinical Research Organization headquartered in Ahmedabad, India. With operations across India, USA, Canada, Spain, UK, and Poland, Lambda delivers end-to-end clinical research services to innovator, biotech, and generic pharmaceutical companies worldwide.
Educational Requirements for Officer Job Role
-
Bachelor’s degree in Pharmacy
Key Responsibilities
- Perform quality review of processed ICSRs in compliance with SOPs, WIs, and regulatory timelines
- Verify duplicate searches, data entry, drug coding, MedDRA coding, listedness, and causality assessments
- Review narratives, expediting assessments, and overall case quality
- Ensure cases meet global regulatory reporting standards prior to submission
- Review and provide feedback on SOPs, WIs, templates, and training materials
- Communicate critical quality issues to Line Manager and QPPV
- Maintaining accurate documentation of review findings and quality observations is essential for this Officer Job role
- Deliver training and guidance to case processors and new joiners
- Collaborate with Team Leaders to escalate and resolve quality concerns
- Support Group Leader in achieving 100% regulatory compliance
- Provide pharmacovigilance quality advice to clients and internal teams
- Mentor junior team members to improve overall quality performance
- Stay updated on regulatory changes and implement quality improvements
- Assist in developing and revising quality-related SOPs and PV processes
- Communicate with clients or regulatory agencies on quality matters when required
Skills Required for Officer Job Role
- Pharmacovigilance case processing and quality review
- Strong knowledge of ICH guidelines, GVP, and global PV regulations
- Expertise in MedDRA coding and drug dictionaries
- Hands-on experience with safety databases such as Argus, ARISg, or Veeva
- Strong analytical skills and attention to detail
- Excellent written and verbal communication skills in English
Why This Job Role?
This Officer Job role offers hands-on experience in pharmacovigilance quality operations within a global CRO. It is ideal for professionals aiming to strengthen regulatory compliance expertise, mentor junior team members, and contribute to high-quality safety reporting in an international clinical research environment. Graduates seeking B pharma jobs or Pharmacy jobs can apply now.
