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Senior Director, Drug Safety and Pharmacovigilance Operations
Spyre Therapeutics. Provide operational leadership for pharmacovigilance activities, including case management, vendor governance, regulatory compliance, PV QMS, inspection and audit readiness, training, and performance metrics .
About the role
Key responsibilities & impact- Provide operational leadership for pharmacovigilance activities, including case management, vendor governance, regulatory compliance, PV QMS, inspection and audit readiness, training, and performance metrics
- Oversee DSPV contracts, budgets, invoices, vendors, consultants, service providers, and business partners
- Oversee end-to-end case processing for clinical development programs, including collection, review, processing, follow-up, reconciliation, and reporting of safety information
- Lead operational oversight of the Argus global safety database, including workflows, vendor activities, data outputs, reporting, compliance, business continuity, and disaster recovery
- Oversee expedited safety reporting, including SUSAR submissions
- Establish and monitor case-processing workflows, KPIs, compliance metrics, and operational deliverables
- Lead vendor governance meetings, Safety Management Team meetings, cross-functional program teams, and safety governance forums
- Develop and maintain operational plans, SOPs, work instructions, workflows, and DSPV processes
- Oversee safety-data reconciliation, analysis, reporting, surveillance, safety reports, listings, narratives, DSURs, 6M line listings, CSRs, and clinical documents
- Support emerging safety concern evaluation, health authority responses, Data Monitoring Committee meetings, and Safety Advisory Committee meetings
- Oversee and continuously improve the DSPV QMS, audit and inspection readiness, CAPAs, remediation, and compliance improvements
- Maintain DSPV documentation in SharePoint and electronic trial master file systems
- Partner with IT and vendors on data security, data protection, access, system continuity, business continuity, and disaster recovery
- Lead DSPV training curriculum and oversee vendor training compliance
- Report to the Senior Vice President, Drug Safety and Pharmacovigilance
Requirements
What you’ll need- Master’s degree in a relevant field (Life sciences) or equivalent combination of education and experience; nursing degree (RN) or pharmacy degree (PharmD) 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, and safety-data analytics
- Demonstrated experience with case processing, safety-database oversight, vendor governance, audit and inspection readiness, and budget and invoice management
- Experience managing and providing oversight of pharmacovigilance service providers and safety-database hosting partners
- Strong knowledge of ICH guidelines and applicable U.S. and European pharmacovigilance regulations and requirements
- Experience preparing safety-data outputs for aggregate and periodic safety reports (DSUR, 6MLLs)
- Excellent analytical and problem-solving skills, with the ability to interpret complex data and translate findings into actionable drug development strategies
- Excellent communication and interpersonal skills, with the ability to motivate teams and collaborate effectively across functions
Benefits
Comp & perks- Market competitive compensation and benefits package
- Performance bonus
- Equity grant opportunities
- Health benefits
- Welfare benefits
- Retirement benefits
- Unlimited PTO
- Two one-week company-wide shutdowns each year
- Professional development opportunities
- Remote working environment with frequent in-person meetings
- Opportunity to work in a fast-paced, dynamic environment, help shape the culture of a young company, contribute broadly to advancing meaningful medicines, and learn quickly