Officer Job at Lambda Therapeutic | Pharmacy Graduates Apply Now
Lambda Therapeutic Research Ltd. is hiring for the position of Officer – ICSR Quality Review at its global headquarters in Ahmedabad, India. This Officer Job offers an excellent career step for Life Science or Pharmacy professionals with 2–4 years of experience in pharmacovigilance case processing and quality control. The Officer will be responsible for ensuring 100% regulatory compliance of Individual Case Safety Reports (ICSRs) by conducting rigorous audits of data entry, MedDRA coding, and narrative quality before submission to global health authorities.
- Job Title: Officer
- Location: Ahmedabad, India
- Req ID: 1487
About The Company
Lambda Therapeutic Research Ltd. is a premier global full-service Contract Research Organization (CRO) headquartered in Ahmedabad, India. Founded in 1998, the organization has expanded its strategic presence to include facilities in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK), and Warsaw (Poland). Lambda provides end-to-end clinical research solutions—including bioanalytical, clinical trials, and pharmacovigilance services—to global pharmaceutical and biotech innovators. In fact, if you are interested in an Officer Job, Lambda offers a strong foundation for your next career move.
Job Details
- Perform quality review of processed ICSRs, ensuring compliance with SOPs, WIs, regulatory guidelines, and timelines.
- Verify duplicate search, data entry, drug coding, MedDRA coding, listedness, causality assessment, expediting assessment, and narrative quality.
- Ensure cases meet regulatory reporting standards and are ready for submission. 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 standards and accurate documentation of review findings. Ensure adherence to quality, consistency, and compliance with global PV requirements. Taking on the Officer Job responsibilities also means upholding global quality benchmarks every day.
- Deliver training and guidance to case processors and new joiners on quality standards.
- Collaborate with Team Leaders to escalate quality concerns and support resolution. Support Group Leader in achieving 100% regulatory compliance through timely and accurate reviews.
- Provide pharmacovigilance quality advice to clients and colleagues as needed. Mentor and assist less experienced team members to improve quality performance. Stay updated on regulatory changes and implement quality improvements accordingly; this proactivity is valued in any Officer Job.
- Assist in developing and revising quality-related SOPs and processes for Lambda’s PV Department and clients.
- Communicate with clients and/or regulatory agencies regarding quality matters when required. Perform any other tasks assigned by the Line Manager to meet business needs.
Experience
- 2–4 years of experience in pharmacovigilance case processing and quality review, which is ideal if you are pursuing an Officer Job.
- Strong knowledge of ICH guidelines, GVP, and global PV regulations.
- Expertise in MedDRA coding, drug dictionaries, and safety databases (e.g., Argus, ARISg, Veeva).
- Excellent attention to detail, analytical skills, and ability to identify quality gaps. Strong written and verbal communication skills in English.
Educational Qualification
Bachelor’s degree in Pharmacy, or related field is required for consideration for this Officer Job at Lambda.
CTC Range
INR 300000 – 600000. Notably, the Officer Job compensation package is competitive within the industry.
