job title:officer-literature screening(lambda)

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.

EXPERIENCE

Candidates given priority if they have done Pharmacovigilance Certification Course

EDUCATIONAL QUALIFICATION

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