Clinical Safety Specialist

Job Description

Job Summary

• The Clinical Safety Specialist is responsible for safety and potential complaint data throughout the clinical study to ensure compliance with respect to the reporting of clinical study safety and potential complaint data to meet regulatory requirements.
• The client Clinical Safety Specialist will partner with various colleagues across Healthcare (e.g., other members of the client Clinical Safety team, other client functions, Regulatory Affairs, Clinical teams in the Operating Units) to manage adverse event, death, and device deficiency reporting in compliance with applicable regulatory standards and Healthcare internal requirements.

Duties and Responsibilities:

• 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.
• Interact with investigational sites and clinical monitors to obtain additional pertinent information as indicated in the Clinical Investigation Plan (CIP).
• Ensure consistency in the assessment of clinical safety events.
• 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.
• Ensure appropriate distribution and notification of SAEs and U[S]ADEs to appropriate personnel, partners, and investigational sites per CIP.
• 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.
• Assist with the writing of safety sections of CIPs and may present Clinical Safety requirements at investigator meetings.
• Support study audit for Safety-specific topics.
• Facilitate Clinical Event Committee (CEC) work (author CEC charter, review source documents, ensure all CEC events are adjudicated by CEC).
• Support database snapshot activities (e.g., meet with study team, review timelines, perform reconciliation and data cleaning activities to be audit & snapshot ready).
• Prepare, attend and/or lead Safety Trending meetings.
• Perform other Clinical Safety tasks as assigned.

Education:

• Equivalent to a bachelor’s degree.

Experience:

• Minimum 1 year of experience required.

HM’s Top Needs:

• Basic medical terminology and interpretation of clinical data – capable of reading and comprehending medical records and imaging reports (clinical, medical, nursing, or radiological background is welcome!).
• Proficiency in Microsoft Office (Excel, Word, PowerPoint) with a basic understanding or willingness to learn Systems & Technology (Safety Databases & Tools).
• Fundamental knowledge of Clinical Research.