Job Description:
- Process adverse event reports received from sites/reporters.
- Perform QC review of completed individual and periodic safety reports.
- Complete data entry including writing of adverse event narrative and provide preliminary assessment of event seriousness and expectedness/listedness as per applicable Reference Safety Information.
- Generate adverse event queries, liaise with the medical reviewers/client 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.
- 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.
Apply now
- Process adverse event reports received from sites/reporters.
- Perform QC review of completed individual and periodic safety reports.
- Complete data entry including writing of adverse event narrative and provide preliminary assessment of event seriousness and expectedness/listedness as per applicable Reference Safety Information.
- Generate adverse event queries, liaise with the medical reviewers/client 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.
- 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.
Apply now
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