- Responsible for medical review and assessment of seriousness, causality and labeling of adverse events within agreed timeframes and to a high standard of accuracy, in compliance with Client standard operating procedures and global regulatory requirements.
- Management of the Affiliate Mailbox reconciliation of reports per process and performance of all written follow up attempts to include both Responsible and Non serious cases
- Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements.