Lambda Therapeutic Research Ltd., headquartered in Ahmedabad, India, is a globally renowned organization specializing in pharmacovigilance solutions. With over 160 dedicated professionals, the company offers end-to-end safety monitoring services for a range of products, including generics, vaccines, combination products, and medical devices. Lambda’s robust expertise, cutting-edge technology, and commitment to regulatory compliance have supported over 265 clinical trials across diverse therapeutic areas.
Key highlights of Lambda’s pharmacovigilance services include:
- Global Expertise: A skilled team of physicians and specialists ensuring drug safety.
- Advanced Technology: Automated, web-based pharmacovigilance systems compliant with international standards.
- Comprehensive Framework: Thorough safety monitoring for better patient outcomes.
Job Responsibilities
As an Officer in Literature Screening, your primary role will involve evaluating global scientific and medical literature to ensure drug safety compliance. Key responsibilities include:
- Reviewing literature as per company SOPs, regulatory requirements, and guides.
- Maintaining organized records of literature safety reports.
- Preparing, revising, and reviewing SOPs, work instructions (WIs), templates, and training documents.
- Supporting case processing tasks, such as data entry, MedDRA coding, listedness assessment, and narrative writing.
- Uploading files to create safety IDs, conducting duplicate searches, and tracking cases from regulatory authorities.
- Performing weekly reconciliation of regulatory cases with their sources.
- Communicating urgent safety issues to the Line Manager and Qualified Person for Pharmacovigilance (QPPV).
- Ensuring high standards in all internal and external communications.
Qualifications Required
Candidates should meet the following qualifications:
- Education: B.Pharm, M.Pharm, or Pharm D (preferably in Pharmacology).
- Experience: A Pharmacovigilance Certification Course is an added advantage.
Key Skills for Success
To excel in this role, candidates should possess:
- Strong accountability and work ethic.
- Excellent communication and interpersonal skills.
- Leadership abilities and a proactive approach.
- Flexibility, planning, and organizational skills.
- Attention to detail with a strong technical foundation.
