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Company

BioCryst Pharmaceuticals, Inc. · 10 hours ago

Sr. Product Safety Associate - Postmarketing (contract)

Triangle Area

Full-time, Contract

Remote

Mid, Senior Level

4+ years exp

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BiotechnologyClinical Trials

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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.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Postmarketing adverse event processingMedDRA codingSafety databases e.g.Safety databases ArgusPharmacovigilance guidelinesIndustry experienceInternational regulations knowledgeAdapt

Required

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.

Company

BioCryst Pharmaceuticals, Inc.

BioCryst Pharmaceuticals is a global biotechnology company with a deep commitment to improving the lives of people living with hereditary angioedema (HAE) and other rare diseases.

Founded in 1986

Birmingham, Alabama, USA

501-1000 employees