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About the Role

The Clinical Safety Reviewer / Senior Clinical Safety Reviewer is responsible for reviewing adverse event and serious adverse event reports from assigned projects, clinical studies, and post-marketing spontaneous reports. This role ensures completeness and clarity, initiates follow-up actions, and participates in triaging reports for regulatory purposes, demonstrating knowledge of safety concepts per ICH and FDA guidelines.

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 events for seriousness and causality.
• Prepares narratives and assists in the presentation of cases for adjudication by the Clinical Events Committee (CEC).
• Tracks AEs, monitors timelines for event processing, reviews summary safety data at regular intervals, and monitors 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 Clinical Trial Affairs (CTA) team members and clinical trial core team members.
• Participates in or is responsible for reconciliation of device/drug safety databases and clinical study databases for adverse event reporting and tally.
• Evaluates clinical databases for non-site reported adverse events and their follow-up.
• May train and mentor other staff on safety processes.
• Reviews protocol safety sections and 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 the Food and Drug Administration, including 510(k) and Pre-Market Approval (PMA) submissions, responses to FDA questions, and preparation at FDA advisory panels.
• Participates in developing and maintaining Device/Drug Safety Information (DSI) infrastructure, such as drafting and/or reviewing 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).

Requirements

• 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.

Skills

• ICH guidelines
• FDA guidelines
• Device/drug safety reporting
• Good Clinical Practices
• Adverse event triage
• Case report forms (CRFs)
• Standard Operating Procedures (SOPs)
• Safety databases
• Clinical Events Committee (CEC)
• Data Safety Monitoring Board (DSMB)
• Microsoft Outlook
• Microsoft Word
• Microsoft Excel
• Database programs
• Communication skills
• Writing skills
• Organizational planning
• Project management
• Time management
• Clinical triage

Location

• Mid-town office

Work Type

• Hybrid

Experience Level

• Senior

Education Level

• M.D. or D.O. degree
• Bachelor’s degree in a life science
• B.S.N.
• Registered Nurse
• Equivalent with at least 2 years safety experience

Salary/Compensations

• $70,000 - $78,000 per year

Benefits

• Choice of health plans include medical, Dental, and vision coverage
• Company-paid short-term and long-term disability and life insurance
• Health and dependent care flexible spending accounts
• Pre-tax travel expenses through TransitChek program
• 401(k) plan
• Generous paid time off (PTO)
• Fourteen paid holidays each year

About the Company

• CRF is an equal opportunity employer.
• We strive to enhance and save patient lives every day.

Equal Opportunity

• CRF is an equal opportunity employer.