Senior Director, Drug Safety and Pharmacovigilance Operations

About this role

Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, IL-23, and IL-17A/F as well as rational combination programs.

Role Summary:
The Senior Director, Drug Safety and Pharmacovigilance (DSPV) Operations will provide operational leadership for pharmacovigilance activities, including case management, vendor governance, regulatory compliance, the PV Quality Management System (QMS), inspection and audit readiness, training, and performance metrics. This individual will also oversee DSPV contracts, budgets, and invoices.
Serving as the subject matter expert for outsourced safety operations, the Senior Director will oversee case processing, expedited reporting, and activities related to the Argus global safety database (GSDB), including reporting, business continuity, and disaster-recovery planning.
Responsible for reports preparation and vendor management for GSDB related activities. Serves as lead for PV compliance, QMS, and inspection /audit readiness for the DSPV function, and for the organization and oversight of the Safety Management Plans (SMP), Safety Management Team (SMT) meetings, Vendor Oversight Plan (VOP).
As the case management lead, the Senior Director will monitor case-processing activities performed by patient support programs (PSPs), vendors, and business partners. This individual will ensure compliance with applicable study protocols, SMPs, VOPs, SOPs, work instructions (WIs), study plans, contractual obligations, and established key performance indicators (KPIs).
This position reports to the Senior Vice President, Drug Safety and Pharmacovigilance.
Key Responsibilities:
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…