Safety Specialist

• Regularly monitor and manage GPS mailboxes
• Communicate with safety vendors regarding individual case safety reports and aggregate reports/listings
• Manage reviews of ICSRs, listings, tables, and figures for completeness and quality
• Manage serious adverse event reconciliation across post-marketing and clinical trial databases and listings
• Collaborate with clinical, medical, regulatory, healthcare professional, consumer, and contracted-resource stakeholders to obtain safety information
• Participate in meetings and take minutes as required
• Support generation of aggregate safety reports
• Communicate with business partners and distributors regarding receipt and transmission of safety information under applicable data exchange agreements
• Attend GPS operational meetings and contribute as a subject matter expert
• Identify issues and improvement areas and escalate appropriately
• Contribute to developing new processes and procedures
• Support implementation of new processes and systems
• Perform activities in compliance with client controlled procedures and applicable global and local regulations
• Perform other tasks assigned by the line manager or Head of GPS

Safety Specialist jobs in North Carolina

Senior Safety Specialist