Review and assess clinical study Adverse Events (AEs) including Serious Adverse Events (SAEs) and device deficiencies
Review non-AE Case Report Forms to detect potential complaint and potential unreported AEs. Ensure consistency in the assessment of clinical safety events
Interact with investigational sites and clinical monitors to obtain additional pertinent information as indicated in the Clinical Investigation Plan (CIP)
Work with Regulatory Affairs and the Product Complaint Reporting teams to ensure timely reporting of AEs, SAEs, and Unanticipated Serious Adverse Device Effects (U[S]ADEs) and potential complaints
Act as liaison for safety-related questions (e.g., to study team, field support, monitors, and study sites) Author Clinical Safety Management and Potential Complaint Plan (CSMPCP) for assigned studies
Assist with preparation of assigned section of safety reports for annual reports, clinical study reports, and other documents as required
Collaborate with Data Management and other departments on the development of case report forms, study specific safety reports, and other study specific forms.
Qualifications
Education background Graduate in Life science
English speaking is a requirement to be successful in this role
