Product Safety Associate – Postmarketing

BioCryst Pharmaceuticals, Inc.

. Monitor the electronic safety mailbox by identifying, triaging, tracking, routing, and filing postmarketing safety information .

Posted 10/15/2026full-timeRemote • North Carolina • United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in pharmacovigilance and drug safety, with a strong focus on adverse event case processing, vendor oversight, and compliance with global regulations. Proficient in managing documentation and operational workflows while maintaining high accuracy and attention to detail.

Highest-signal resume keywords

Pharmacovigilance ExperienceAdverse Event Case ProcessingSafety Database ProficiencyVendor OversightMicrosoft Office Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Adverse Event ReportingCase ProcessingData EntryReconciliation ActivitiesDocumentation ManagementQuality ControlOperational WorkflowsTracking SystemsInspection ReadinessPharmacovigilance Regulations

Soft Skills

Attention to DetailOrganizational SkillsEffective CommunicationCollaborationAbility to Manage Multiple Priorities

Tools & Technologies

Safety Database (e.g., Argus)Microsoft OutlookMicrosoft ExcelMicrosoft WordMicrosoft Teams

Industry Keywords

PharmaceuticalBiotechnologyHealthcareGood Pharmacovigilance Practices (GVP)Postmarketing Safety Information

About the role

Key responsibilities & impact

Monitor the electronic safety mailbox by identifying, triaging, tracking, routing, and filing postmarketing safety information
Book in and track postmarketing adverse event reports received from global sources
Support case owners with adverse event case processing, follow-up, and outstanding case query management
Assist with follow-up involving reporters, vendors, and license partners to obtain complete and accurate case information
Assist with safety database data entry during increased workload or high case volume
Coordinate quality control and medical review activities with GDSP team members and Medical Directors
Perform adverse event and case exchange reconciliation with vendors and license partners, including discrepancy tracking, investigation, and resolution
Maintain reconciliation trackers and supporting documentation
File and maintain adverse event information, reconciliation records, and other safety documentation
Support vendor and license partner oversight, including maintaining Excel trackers, preparing meeting agendas, attending meetings and teleconferences, documenting discussions and decisions, and distributing meeting minutes
Track vendor and license partner commitments, action items, and deliverables
Contribute to inspection readiness through accurate, complete, and audit-ready safety documentation
Maintain knowledge of global pharmacovigilance regulations, guidelines, and Good Pharmacovigilance Practices
Perform additional operational support activities as assigned

Requirements

What you’ll need

Bachelor's degree in a scientific discipline or an equivalent combination of education and relevant experience
Minimum of 2 years of experience in pharmaceutical, biotechnology, healthcare, or related industry
At least 1 year of pharmacovigilance or drug safety experience preferred
Experience managing shared mailboxes, tracking systems, operational workflows, and documentation preferred
Experience supporting vendor oversight, license partner interactions, or reconciliation activities preferred
Familiarity with adverse event case processing and postmarketing pharmacovigilance activities preferred
Experience working with a safety database (e.g., Argus) preferred
Proficiency in Microsoft Office applications, including Outlook, Excel, Word, and 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
Ability to work independently while collaborating effectively within a cross-functional environment
Knowledge of international postmarketing adverse event reporting requirements and Good Pharmacovigilance Practices (GVP) preferred
Ability to successfully function in a rapidly changing environment

Benefits

Comp & perks

Contract position
Full-time schedule
Equal employment opportunity protections
Commitment to compliance with federal, state, and local law