1. Receive, review, and process Individual Case Safety Reports (ICSRs) from healthcare professionals, patients, or internal sources
2. Perform data entry and quality checks in safety databases
3. Ensure timely reporting of adverse events to national regulatory authorities, partners, and license holders in accordance with global and local requirements
4. Assist in preparation and submission of Periodic Safety Update Reports (PSURs), and Risk Management Plans (RMPs)
5. Maintain safety files and pharmacovigilance documentation in audit-ready condition
6. Collaborate with cross-functional teams (regulatory, QA, sales and marketing) and external stakeholders
7. Support pharmacovigilance training and awareness activities
8. Monitor literature and social media for local safety signals
9. Participate in safety signal detection and evaluation activities
10. Ensure compliance with company SOPs and pharmacovigilance regulations