Officer- Literature Screening

ORGANISATIONAL OVERVIEW

At Lambda Therapeutics, we provide end-to-end pharmacovigilance solutions tailored for a variety of products, including generics, combination products, vaccines, and medical devices. Our extensive experience encompasses all phases of drug safety monitoring, ensuring compliance with regulatory standards throughout the entire lifecycle of medicinal products.

Key Highlights of Our Pharmacovigilance Services:

• Global Expertise: With a dedicated team of over 160 professionals, including physicians and pharmacovigilance specialists, we have successfully supported more than 265 clinical trials across diverse therapeutic areas.
• Robust Framework: Our well-established pharmacovigilance framework guarantees thorough safety monitoring and adherence to regulatory requirements, empowering drug safety and enhancing patient well-being.
• Advanced Technology: We utilize an automated web-based pharmacovigilance solution compliant with international standards, which streamlines processes and ensures accuracy in data handling.

JOB DETAILS

1. Review global scientific and medical literature per company SOPs, WIs, guides, and relevant regulations.
2. Maintain organized records of all literature safety reports received and reported.
3. Prepare, revise, and review SOPs, WIs, templates, guides, and training documents.
4. Communicate urgent safety issues to the Line Manager.
5. Maintain high standards in all internal and external communications.
6. Support case processing, including data entry, drug coding, MedDRA coding, listedness assessment, expediting assessment, and ICSR narrative writing per SOPs, WIs, and guides.
7. Enter literature cases from PubMed.
8. Create safety IDs by uploading/importing files or manually as needed.
9. Perform duplicate searches.
10. Initiate cases in the database by creating safety IDs.
11. Track all cases received from regulatory authorities.
12. Conduct weekly reconciliation of regulatory cases with their sources.
13. Prepare, revise, and review SOPs, WIs, templates, guides, and training documents.
14. Communicate urgent safety issues to the Line Manager and QPPV.
15. Ensure high standards in all communications, maintaining records of both internal and external communications.

KEY DELIVERABLES

ALLIED RESPONSIBILITIES

EXPERIENCE

Candidates given priority if they have done Pharmacovigilance Certification Course

EDUCATIONAL QUALIFICATION

B. Pharm, M. Pharm, Pharm D (Any, Preferably in Pharmacology).

COMPETENCIES