Product Safety Operations Specialist

BioCryst Pharmaceuticals; North Carolina; On-site; USD 70,000 - 95,000; Full time

Job summary

BioCryst Pharmaceuticals is seeking a Product Safety Associate to support postmarketing safety operations, manage the safety mailbox, and assist with adverse event case processing, vendor and license partner oversight, and reconciliation activities.

You will route safety information globally, assist with data entry during peak workload, and coordinate with Medical Directors for QC and review, maintaining safety records and inspection readiness.

Qualifications

• Bachelor's degree in a scientific discipline or equivalent.
• Minimum 2 years in pharma/biotech/healthcare with at least 1 year in pharmacovigilance or drug safety.
• Experience managing shared mailboxes, tracking systems and documentation.
• Familiarity with adverse event processing and safety databases.

Responsibilities

• Monitors safety mailbox, triages, tracks, routes, and files postmarketing safety information.
• Books in and tracks postmarketing adverse event reports from global sources.
• Supports case owners with AE case processing and follow-up queries.
• Assists with data entry into safety database during high workload.
• Coordinates quality control and medical review with GDSP team members.
• Maintains reconciliation records and safety documentation for audits.

Skills

Attention to detail

Organizational skills

Communication

Independent work

Education

Bachelor's degree in a scientific discipline

Tools

Argus

Microsoft Excel

Microsoft Outlook

Microsoft Word

Microsoft Teams

Job description

BioCryst Pharmaceuticals is seeking a Product Safety Associate to support postmarketing safety operations, manage the safety mailbox, and assist with adverse event case processing, vendor and license partner oversight, and reconciliation activities.

You will route safety information globally, assist with data entry during peak workload, and coordinate with Medical Directors for QC and review, maintaining safety records and inspection readiness.