- Complete data entry in safety database including writing of adverse event narrative and preliminary assessment of event seriousness and expectedness/ listedness as per Reference Safety Information.
- Generate adverse event queries, liaise with the medical reviewers and clients to agree upon the queries, and send request for additional information to the sites/reporter.
- Engage with the Site Monitors to ensure follow up information is obtained from site effectively.
- Forward safety report documents to designated medical reviewer for review.
- Forward completed safety report documents to clients and other relevant parties.
- Foster constructive and professional working relationships with all project team members, internal and external.
- File documents according to project specific requirements (electronically or in hard copy as applicable).
- Ensure case files are compliant with SOPs.
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