Clinical Safety Reviewer

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This range is provided by Cardiovascular Research Foundation. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$70,000.00/yr - $78,000.00/yr

This role is subject to a flexible hybrid work arrangement requiring a minimum of 1-2 pre-determined days per week in our mid-town office.

Summary

The Clinical Safety Reviewer / Senior Clinical Safety Reviewer is primarily responsible for reviewing adverse event and serious adverse event reports from an assigned project(s), clinical studies and/or post marketing spontaneous reports. Responsible for completeness and clarity, defining and initiating follow-up through the appropriate channels, and participating in the triage of these reports for regulatory reporting purposes. Demonstrates knowledge of safety concepts, per ICH and FDA guidelines per device/drug safety reporting requirements.

Identifies proper case regulatory reporting requirement and seeks assistance when necessary. Identifies and utilizes resources and support when available for adverse event triage and management. Applies Good Clinical Practices in documentation of phone, electronic, and/or fax correspondence regarding initial case reports and follow-up per CRF’s SOPs. Competently performs clinical triage per CRF SOPs. Identifies pertinent clinical information in adverse event reports and incorporates information in narrative.

Essential Duties And Responsibilities

• Receives initial and follow-up adverse events (AEs) reports via email, case report forms and/or electronic data capture.
• Maintains AE data collection and documentation as per CRF SOP including entering adverse event data into safety databases.
• Recognizes missing/incorrect data and initiates missing data queries/data clarification queries to clinical sites regarding adverse events.
• Requests appropriate source documentation to analyze adverse event for seriousness and causality and prepares narratives for and assists in the presentation of cases for adjudication by the Clinical Events Committee (CEC).
• Responsible for tracking AEs, monitoring timelines for event processing, reviewing summary safety data at regular intervals, and monitoring adjudication results of the Clinical Events Committee (CEC) or Data Safety Monitoring Board (DSMB).
• Interfaces with project management, functional team members and investigators to ensure a timely and precise safety reporting process.
• Provides reports and statistics in the dissemination of safety information to the Clinical Trial Affairs (CTA) team members and clinical trial core team members, as appropriate, including CEC meeting minutes, DSMB charter development and completion and summary reports.
• Participates in or is responsible for reconciliation of device / drug safety databases and clinical study databases for adverse event reporting and tally. This includes evaluating clinical database for non-site reported adverse events and their follow-up.
• May train and mentor other staff on safety processes.
• Reviews protocol safety sections, as well as, instructions for use of investigational devices before submission for FDA approval.
• Attends investigator and coordinator meetings representing the Device / Drug Safety Information (DSI) functional group.
• Provides advice on the reportability of adverse events and other clinical trial issues to regulatory agencies and health authorities.
• Provides Clinical Safety support in working with Food and Drug Administration, including 510(k) and Pre-Market Approval (PMA) submissions, responses to FDA questions, and preparation at FDA advisory panel.
• Participates in developing and maintaining Device / Drug Safety Information (DSI) infrastructure such as the drafting and/or reviewing of SOPs, guidelines and work instructions.
• Participates in the development and review of corrective action plans as requested on internal / external…