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).
