Senior Director, Drug Safety and Pharmacovigilance Operations
New
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Spyre TherapeuticsBiotechnology
US- RemoteFull-TimeDirector
Salary$295,000 to $311,000
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Job Details
- Experience
- Minimum of eight years of experience in pharmacovigilance operations or a related function
Requirements
- Master’s degree in a relevant field (life sciences) or equivalent combination of education and experience.
- Nursing (RN) or pharmacy (PharmD) degree preferred.
- Minimum of eight years of experience in pharmacovigilance operations or a related function within the biotechnology or pharmaceutical industry.
- Hands-on experience with global safety databases, preferably Argus.
- Proven experience with safety-data analytics.
- Demonstrated experience in case processing and safety-database oversight.
- Demonstrated experience in vendor governance, budget management, and invoice management.
- Proven track record of maintaining audit and inspection readiness.
- Strong knowledge of ICH guidelines and U.S. and European pharmacovigilance regulations.
- Experience preparing safety-data outputs for aggregate and periodic safety reports (DSUR, 6MLLs).
- Excellent analytical and problem-solving skills.
Responsibilities
- Provide operational leadership and oversight of DSPV vendors, consultants, and business partners.
- Manage end-to-end clinical development case processing, including collection, review, and expedited reporting.
- Serve as the operational subject matter expert for the Argus global safety database.
- Maintain audit and inspection readiness for the DSPV function, including QMS, CAPAs, and remediation.
- Collaborate cross-functionally on safety-data review, analysis, and surveillance for aggregate safety reports.
- Oversee DSPV budgets, contracts, statements of work, and invoice management.
- Develop and maintain DSPV processes, including SOPs, safety management plans, and training curriculum.
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