Company: Amneal Pharmaceuticals
Position: Pharmacovigilance
Designation: Executive / Senior Executive
Total Experience: 2-6 Years
Qualification: B.Pharm / M.Pharm
Job Location: Ahmedabad (No Work from Home Option Available)
Job Responsibilities :
1. Perform global literature screening for the Amneal portfolio.
2. Perform validation, segregation and prioritization of the literature reports along with maintenance of various case processing-related trackers.
3. Perform initial checks/search database to prevent duplicate entries, create case files or enter drug safety reports in the tracking tool and/or safety database.
4. Ensure effective functioning of Global Literature monitoring in compliance with applicable SOPs/WIs, agreements/contracts and local and global regulatory guidelines.
5. Keep the global literature screening module up to date. Review any addition/deletion/modification of search strings/products configured in the global literature screening module (EMBASE).
6. Coordinate with concerned stack holder(s) for collecting the follow-up information, as and when required.
7. Manage full-text article procurement/translation requests, as and when required.
8. Identify process improvements in the Global literature monitoring process and provide feedback/guidance as required.
9. Assist in preparation/revision of SOP, Work instructions, templates and guidance training documents concerning the literature process.
10. Support Health Authorities' inspections and audits, and the development of Corrective & Preventative Actions (CAPA) to address safety findings concerning the literature process.
11. Impart training related to literature process, as and when required
Interested candidates may share their CV at kavitriy@amnealindia.com with the subject line "Application for Pharmacovigilance"
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