Spyre Therapeutics - Senior Director, Drug Safety and Pharmacovigilance Operations

• Case Management and Safety Systems • Provide oversight of end-to-end case processing for clinical development programs, ensuring timely, accurate, and compliant collection, review, processing, follow-up, reconciliation, and reporting of safety information. • Serve as the operational subject matter expert and lead for the Argus global safety database, including workflows, vendor activities, data outputs, reporting, system compliance, and applicable business-continuity and disaster-recovery processes. • Oversee expedited safety reporting, including SUSAR submissions, in accordance with applicable regulatory requirements and timelines. • Establish and monitor case-processing workflows, KPIs, compliance metrics, and operational deliverables; review and escalate performance issues and trends. • Monitor safety operations performed by PSPs, vendors, and business partners for compliance with protocols, SMPs, VOPs, SOPs, work instructions, study plans, contracts, and applicable regulations. • Serve as the unblinded Drug Safety Operations representative, as required. • Vendor and Operational Governance • Provide operational leadership and oversight of DSPV vendors, service providers, consultants, and business partners, including clear definition of roles, responsibilities, deliverables, and escalation pathways. • Lead or participate in SMTs, vendor governance meetings, cross-functional program teams, and other safety governance forums; track actions, risks, issues, and escalations through resolution. • Develop and maintain operational plans, SOPs, work instructions, workflows, and other DSPV processes in collaboration with internal stakeholders and external providers. • Oversee SMPs and VOPs and ensure their implementation across applicable programs and vendors. • Manage DSPV vendor and consultant budgets, contracts, statements of work, change orders, and invoices. • Safety Data, Surveillance, and Reporting • Oversee safety-data reconciliation with Data Management, Clinical CROs, and other stakeholders and ensure timely resolution of discrepancies. • Collaborate with Safety Physicians, Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and external vendors on safety-data review, analysis, reporting, iDMC, and surveillance. • Prepare and oversee safety reports, listings, narratives, and other data outputs supporting risk management, regulatory submissions, and safety governance. • Support identification and evaluation of emerging safety concerns • Support preparation and review of health authority responses and aggregate and expedited safety reports, including DSURs, and 6M line listings. • Support safety-related sections of CSRs and other clinical documents and provide safety-data outputs for independent Data Monitoring committee meetings. • Support the Senior Vice President, DSPV, in preparation and facilitation of safety governance and Safety Advisory Committee meetings. • Quality, Compliance, and Inspection Readiness • Under the direction of the Senior Vice President, DSPV, and in partnership with Quality Assurance, oversee and continuously improve the DSPV QMS. • Maintain audit and inspection readiness for DSPV activities, systems, vendors, and business partners. • Lead or coordinate DSPV preparation for internal and external audits and regulatory inspections. • Oversee CAPAs, remediation activities, and compliance improvements related to DSPV operations. • Serve as the DSPV subject matter expert for PV compliance and inspection-readiness matters involving case management, safety systems, reporting, workflows, documentation, and KPIs. • Systems, Documentation, and Business Continuity • Oversee the organization, completeness, and maintenance of DSPV documentation within SharePoint and applicable electronic trial master file systems. • Partner with IT and relevant vendors to maintain appropriate data-security, data-protection, access, and system-continuity processes for the GSDB and related systems. • Develop, maintain, and periodically test DSPV business-continuity and disaster-recovery plans for critical systems and operations. • Training • Lead development and maintenance of the DSPV training curriculum and ensure training requirements support applicable SOPs, processes, systems, and regulatory expectations. • Oversee vendor training programs and monitor training completion and compliance. • Other • Perform other duties as assigned.