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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.
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.
