Postmarketing Safety Operations Specialist

BioCryst Pharmaceuticals, Inc.; North Carolina; Hybrid; USD 60,000 - 90,000; Full time

Job summary

BioCryst Pharmaceuticals, Inc. is seeking a Safety Associate to support postmarketing safety operations, including mailbox management, AE case processing, and vendor oversight. The role involves data entry during high workload periods and ensuring timely routing and processing of adverse event reports.

You will assist with follow-up activities, reconciliation with vendors and license partners, and maintain safety documentation to support inspection readiness and regulatory compliance.

Qualifications

• Bachelor's degree in a scientific discipline or equivalent.
• 2+ years in pharma/biotech/healthcare with pharmacovigilance exposure preferred.
• Experience with shared mailboxes, tracking systems, workflows, and documentation preferred.
• Familiarity with safety databases and regulatory requirements preferred.

Responsibilities

• Monitor safety mailbox, triage and route postmarketing safety information.
• Book and track postmarketing adverse event reports from global sources.
• Support case owners with AE case processing and follow-up queries.
• Assist with data entry in the safety database during high workload periods.
• Coordinate QC and medical review with GDSP and Medical Directors.

Skills

Attention to detail

Organizational skills

Communication skills

Independent work

Team collaboration

Education

Bachelor's degree in a scientific discipline

Tools

Argus safety database

Outlook

Excel

Word

Teams

Job description

BioCryst Pharmaceuticals, Inc. is seeking a Safety Associate to support postmarketing safety operations, including mailbox management, AE case processing, and vendor oversight. The role involves data entry during high workload periods and ensuring timely routing and processing of adverse event reports.

You will assist with follow-up activities, reconciliation with vendors and license partners, and maintain safety documentation to support inspection readiness and regulatory compliance.