Product Safety Associate - Postmarketing (Contract)

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

JOB SUMMARY

The ideal candidate is responsible for supporting postmarketing safety operations through safety mailbox management, adverse event (AE) case processing support, vendor and license partner oversight activities, and case reconciliation processes. This role serves as a key operational resource for the intake, triage, tracking, and organization of safety information received from global sources, ensuring the timely routing and processing of adverse event reports. The Product Safety Associate supports case owners with case follow-up and query management activities, assists with postmarketing case data entry during periods of increased workload, and performs reconciliation activities with vendors and license partners. The role also supports partner oversight administration, maintains safety documentation, and contributes to inspection readiness and compliance with global pharmacovigilance requirements.

ESSENTIAL DUTIES & RESPONSIBILITIES

• Monitors the electronic safety mailbox, including identifying, triaging, tracking, routing, and filing postmarketing safety information received from internal and external sources.
• Books in and tracks postmarketing adverse event reports received from global sources.
• Supports case owners with adverse event case processing activities, including case follow-up and management of outstanding case queries.
• Assists with follow-up activities involving reporters, vendors, and license partners to obtain complete and accurate case information.
• Assists with data entry of postmarketing adverse event cases into the safety database in accordance with departmental data entry guidelines and procedures during periods of increased workload or high case volume.
• Coordinates quality control and medical review activities with the appropriate GDSP team members and Medical Directors.
• Performs adverse event and case exchange reconciliation activities with BioCryst vendors and license partners, including tracking, investigation, and resolution of reconciliation discrepancies.
• Maintains reconciliation trackers and supporting documentation to ensure complete and accurate records of reconciliation activities.
• Ensures the filing and maintenance of adverse event information, reconciliation records, and other safety documentation received from BioCryst vendors and license partners in approved departmental repositories.
• Supports vendor and license partner oversight activities, including maintaining project-specific Excel trackers, developing and distributing meeting agendas, attending safety-related meetings and teleconferences, documenting key discussions and decisions, and preparing and distributing meeting minutes.
• Tracks vendor and license partner commitments, action items, and deliverables to support oversight activities and ensure timely follow-up.
• Contributes to inspection readiness activities through the maintenance of accurate, complete, and audit-ready safety documentation.
• Maintains knowledge of current global pharmacovigilance regulations, guidelines, and Good Pharmacovigilance Practices (GVP).
• Performs additional operational support activities as assigned.

EXPERIENCE & QUALIFICATIONS

• 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, with 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.

The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time. BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.

Passionate. Smart. Motivated. We’re all these qualities—but most importantly, we’re committed to making a difference in the lives of those living with hereditary angioedema (HAE) and other rare diseases.

If you’re someone who turns challenges into triumphs and aims to achieve beyond what you think is possible, we’re waiting for you.

Culture is the fabric that binds us together and makes our company a special place to work.

We are powered by our people, and every employee can provide valuable input on how we can achieve our goals through a culture of accountability.

Our bold thinking comes from our "people-first" perspective, where we are united across fronts to do the right thing for patients, without fear of failure—but with embracing the learnings gleaned from setbacks that fuel our self-awareness.

We value ownership, integrity, and the ability to laugh and learn from our mistakes.

We are proud of our ability to reward innovative thinking and grow from personal and professional discovery.