As a Pharmacovigilance Associate I, you will be involved in case processing and related activities to ensure patient safety operations are aligned and executed efficiently.
How You’ll Spend Your Day:
- Case Processing: Manage serious and non-serious adverse events from various post-marketing sources.
- Medical Coding: Ensure accurate and consistent medical coding using MedDRA (Medical Dictionary for Regulatory Activities) for all events in the Safety Database.
- Data Verification: Verify data between source documents and entered data in the Safety Database for event evaluation, suspect drug coding, seriousness, causality, listedness, and narrative writing.
- Follow-Ups and Queries: Evaluate the need for follow-ups and queries with various stakeholders to ensure accurate data transfer.
- Quality Data Analysis: Analyze data for trending and prepare the team for process stabilization.
- Administrative Support: Provide complete responsibility for assigned case processing activities on a day-to-day basis.
- Coordination: Coordinate with internal and external stakeholders to obtain necessary information and update the reporting manager on status reports in real-time.
- Effective Communication: Maintain effective communication with internal departments and external partners, authorities, and vendors to ensure transparency in processes.
