Sr. Product Safety Associate

COMPANY:

At BioCryst, we share a deep commitment to improving the lives of people living with hereditary angioedema (HAE) and other rare diseases. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and injectable protein therapeutics, led by the efforts of our team of expert scientists in our Discovery Center of Excellence in Birmingham, Alabama. Our global headquarters is in Durham, North Carolina and our employees span the globe across sites in multiple countries. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit our website at www.biocryst.com or follow uson LinkedInand Instagram.

JOB SUMMARY:

The ideal candidate is responsible for supporting postmarketing safety operations with regard to adverse event (AE) case processing. This role is also responsible for tracking and organizing incoming postmarketing information.

ESSENTIAL DUTIES & RESPONSIBILITIES:

* Monitor multiple electronic safety mailboxes to include identifying, tracking, and filing AE information.

* Ability to book-in, triage and process postmarketing adverse event reports from all sources globally.

* Ability to compose a comprehensive case narrative and integrate case related information including medical conditions, lab results, and investigational procedures.

* Demonstrates working knowledge of MedDRA to ensure proper coding of adverse event reports.

* Performs follow up activities as required for postmarketing cases, including monitoring the status of outstanding queries.

* Coordinates medical review of individual cases with the appropriate GDSP Medical Director.

* Assists with the coordination and oversight of case processing activities if outsourced to safety vendors.

* Performs quality checks on incoming adverse event reports received from safety vendors.

* Assists with adverse event reconciliation processes with external vendors and licensing partners, as well as product complaint reconciliation with the BioCryst Quality department.

* Ensures filing of adverse event and other safety documentation (such as literature reviews) received from safety vendors and partners in the departmental shared drives.

* Assists with monitoring and tracking of ICSR submissions as well as periodic/aggregate report submissions for all products.

* Assists in the review of standard safety documents such as working practices, reference safety information, pharmacovigilance agreements, and periodic/aggregate reports (DSUR, PBRER) as required.

* Contributes to inspection readiness activities as needed.

* Assists with other duties as assigned such as projects related to the implementation of a safety database and migration of data, creation of new templates/trackers, and data collection for the PSMF.

* May represent the department on project teams or other teams with assistance from senior staff as needed.

* Maintains knowledge of current international pharmacovigilance guidelines and regulations.

EXPERIENCE AND QUALIFICATIONS:

* Bachelor's degree required, preferably in a scientific field.

* At least 4 years of relevant industry experience, of which at least 2 years has been within the pharmaceutical industry in a Product Safety or Pharmacovigilance capacity.

* At least 2 years direct and current experience processing postmarketing adverse event reports.

* Strong knowledge of safety databases (e.g., Argus) and ability to conduct accurate safety database searches with minimal supervision.

* High degree of accuracy and attention to detail.

* Knowledge of international regulations regarding postmarketing adverse event reporting.

* Excellent oral and written communication skills.

* 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.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.