Product Safety Associate – Postmarketing

Job not on LinkedIn

🔥 0 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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BioCryst Pharmaceuticals, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $450M Post-IPO Debt - BioCryst Pharmaceuticals on 2023-04

Healthcare • Consulting • Logistics

BioCryst Pharmaceuticals, Inc. is a global biotechnology company focused on the discovery, development, and commercialization of novel oral small-molecule and protein therapeutics for rare diseases, notably hereditary angioedema (HAE). Founded in 1986, BioCryst uses structure-guided drug design, medicinal chemistry, and advanced technologies to develop first-in-class or best-in-class medicines, and works closely with patients, advocacy groups, and global partners to bring treatments to market.

📋 Description

• 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

• 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

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