Pharmacovigilance Safety Operations Associate

BioCryst; United States; On-site; USD 60,000 - 80,000; Full time

Job summary

BioCryst is seeking a Product Safety Associate to support postmarketing safety operations, including management of safety mailbox, AE case processing, vendor and license partner oversight, and reconciliation activities. You will help route and organize safety information from global sources and assist case owners with follow-up and data entry during peak periods.

This role requires a Bachelor's in a scientific field and at least two years in pharma/biotech with pharmacovigilance experience.

Qualifications

• Bachelor's degree in a scientific discipline or equivalent.
• Minimum 2 years in pharmaceutical/biotech/healthcare with at least 1 year pharmacovigilance or drug safety experience.
• Experience managing shared mailboxes, tracking systems, workflows, and documentation.
• Experience supporting vendor oversight, license partner interactions, or reconciliation activities.
• Familiarity with adverse event case processing and postmarketing pharmacovigilance activities.
• Experience working with a safety database (e.g., Argus).
• Proficiency in Microsoft Office applications (Outlook, Excel, Word, Teams).
• High degree of accuracy and attention to detail.
• Strong organizational skills with the ability to manage multiple priorities and meet deadlines.
• Effective oral and written communication skills.

Responsibilities

• Monitor the electronic safety mailbox, triage and route postmarketing safety information.
• Books in and tracks postmarketing AE reports from global sources.
• Support case owners with AE processing and follow-up queries.
• Assist with vendor and license partner follow-up to obtain complete case information.
• Enter data into the safety database per guidelines during high workload periods.
• Coordinate quality control and medical review with GDSP and Medical Directors.
• Perform AE and case reconciliation with vendors and partners.
• Maintain reconciliation trackers and safety documentation.
• Support vendor oversight activities: trackers, meeting agendas and minutes.
• Track commitments and deliverables for oversight.
• Assist with inspection readiness and GVP compliance.
• Stay updated on global pharmacovigilance regulations.

Skills

Pharmacovigilance experience

MS Office proficiency

Attention to detail

Organizational skills

Cross-functional collaboration

Effective communication

Education

Bachelor's degree in a scientific discipline

Tools

Argus

Job description

BioCryst is seeking a Product Safety Associate to support postmarketing safety operations, including management of safety mailbox, AE case processing, vendor and license partner oversight, and reconciliation activities. You will help route and organize safety information from global sources and assist case owners with follow-up and data entry during peak periods.

This role requires a Bachelor's in a scientific field and at least two years in pharma/biotech with pharmacovigilance experience.