Product Safety Associate - Postmarketing
About the job
- A bachelor's degree in a scientific discipline, or an equivalent combination of education and relevant experience.
- At least 2 years of experience in the pharmaceutical, biotechnology, healthcare, or a related industry.
- Proficiency in Microsoft Office applications, including Outlook, Excel, Word, and Teams.
- High degree of accuracy and attention to detail.
- Organizational skills to manage multiple priorities and meet deadlines.
- Ability to work independently while collaborating in a cross-functional environment.
- Ability to function in a rapidly changing environment.
- Monitor the electronic safety mailbox by identifying, triaging, tracking, routing, and filing postmarketing safety information received from internal and external sources.
- Book in and track postmarketing adverse event reports received from global sources.
- Support case owners with adverse event case processing, including case follow-up and management of outstanding case queries.
- Assist with follow-up involving reporters, vendors, and license partners to obtain complete and accurate case information.
- Assist with data entry of postmarketing adverse event cases into the safety database in accordance with departmental guidelines and procedures during periods of increased workload or high case volume.
- Coordinate quality control and medical review activities with appropriate GDSP team members and Medical Directors.
- Perform adverse event and case exchange reconciliation activities with vendors and license partners, including tracking, investigating, and resolving discrepancies.
- Maintain reconciliation trackers and supporting documentation to ensure complete and accurate records of reconciliation activities.
- File and maintain adverse event information, reconciliation records, and other safety documentation received from vendors and license partners in approved departmental repositories.
- Support vendor and license partner oversight by 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.
- Track vendor and license partner commitments, action items, and deliverables to support oversight and timely follow-up.
- Contribute to inspection readiness by maintaining accurate, complete, and audit-ready safety documentation.
- Maintain knowledge of current global pharmacovigilance regulations, guidelines, and Good Pharmacovigilance Practices.
- Perform additional operational support activities as assigned.
- At least 1 year of pharmacovigilance or drug safety experience.
- Experience managing shared mailboxes, tracking systems, operational workflows, and documentation.
- Experience supporting vendor oversight, license partner interactions, or reconciliation activities.
- Familiarity with adverse event case processing and postmarketing pharmacovigilance activities.
- Experience working with a safety database such as Argus.
- Knowledge of international postmarketing adverse event reporting requirements and Good Pharmacovigilance Practices.
- Effective oral and written communication skills.
About the company
BioCryst Pharmaceuticals develops oral small-molecule drugs aimed at treating rare diseases, with a focus on hereditary angioedema (HAE). The company uses traditional cell biology and medicinal chemistry to design synthetic compounds that target specific protein pathways involved in disease. Its products work as oral therapies that modulate disease-related proteins to reduce symptoms and improve daily functioning, progressing from discovery through clinical trials toward commercialization. BioCryst differentiates itself by concentrating on rare diseases and pursuing oral, non-biologic treatments, leveraging a combined science approach and a patient-focused strategy to bring therapies to market. Its goal is to deliver meaningful, clinically validated treatments that enable patients to engage more fully in everyday activities and improve their quality of life, supported by its drug pipeline and potential licensing opportunities.
Company Size
501-1,000
Company Stage
IPO
Headquarters
Durham, North Carolina
Founded
1986
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Simplify's Take
What believers are saying
- Japan approved pediatric Orladeyo on August 26, 2026, expanding revenue outside America.
- Q2 2026 revenue hit $218.3 million, and management raised 2026 guidance to $715 million.
- CareMed became a national Orladeyo partner on September 8, 2026, widening U.S. access.
What critics are saying
- Pharvaris plans HAE approval in 2027, threatening Orladeyo pricing and persistence.
- BioCryst closed Hoover in October 2026, laying off 47 and shrinking discovery capacity.
- Orladeyo concentration remains existential; one HAE franchise funds BioCryst until navenibart proves itself.
What makes BioCryst Pharmaceuticals unique
- Orladeyo is the only oral HAE prophylaxis approved for children aged two.
- BioCryst now commercializes globally through specialty partners like OrphanPacific and CareMed.
- Management quit internal discovery in 2026, focusing capital on external rare-disease asset acquisitions.
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Benefits
- Remote Work Options