Clinical Safety Reviewer

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 audits and implements plans as required. Demonstrates working knowledge of and coaches others in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with the Code of Federal Regulations (CFRs) and applicable Standard Operating Procedures (SOPs).

Qualifications: M.D. or D.O. degree, (Bachelor's degree in a life science, B.S.N., Registered Nurse, or equivalent with at least 2 years safety experience may be considered).Proficient with Microsoft Outlook, Word, and Excel; basic understanding of database programs is extremely helpful. Must possess excellent communication and writing skills, patience, professionalism and ability to effectively interact with staff and management alike; ability to verbally communicate effectively with Biometrics & Data Management (BDM), Clinical Trial Affairs (CTA), Project Management (PM) and other team members. Ability to multi-task and interface with team members who are working under deadlines. Ability to set priorities and excellent organizational planning, project management and time management skills. Ability to analyze information and perform clinical triage relating to information synthesized from Case Report Forms and other sources.