Clinical Safety Specialist

Overview

• Serve as a Clinical Safety Specialist for a contract role, ensuring compliance with regulatory standards and internal requirements.
• Collaborate with cross-functional teams to manage adverse event reporting and device deficiency assessments.
• Analyze clinical data, medical records, and imaging reports to identify safety concerns.
• Utilize Microsoft Office tools and safety databases for data management and reporting.
• Support clinical study audits and ensure consistency in safety event assessments.
• Prepare safety reports and collaborate on study-specific safety documentation.
• Facilitate Clinical Event Committee activities and ensure adjudication of events.
• Contribute to the development of case report forms and safety sections of clinical study plans.
• Perform other clinical safety tasks as assigned to support study objectives.

Key Responsibilities & Duties

• Review and assess clinical study adverse events, serious adverse events, and device deficiencies.
• Interact with investigational sites and clinical monitors to obtain pertinent information.
• Ensure timely reporting of adverse events and device effects to regulatory bodies.
• Collaborate with regulatory affairs and product complaint teams for compliance.
• Author Clinical Safety Management and Potential Complaint Plans for studies.
• Assist in preparation of safety sections for annual and clinical study reports.
• Support study audits and facilitate Clinical Event Committee activities.
• Prepare and lead safety trending meetings and database snapshot activities.
• Collaborate with data management teams to ensure accurate safety data reporting.

Job Requirements

• Bachelor's degree in science or equivalent educational background required.
• Minimum of 2 years of experience in clinical safety or related field.
• Proficiency in Microsoft Office tools and safety databases.
• Fundamental knowledge of clinical research and medical terminology.
• Ability to read and comprehend medical records and imaging reports.
• Strong analytical and organizational skills for safety event management.
• Experience collaborating with cross-functional teams in clinical settings.
• Willingness to learn new systems and technologies for safety data management.
• Commitment to ensuring compliance with regulatory standards and internal policies.