Senior Director, Drug Safety and Pharmacovigilance (DSPV) Operations

Spyre Therapeutics is a clinical-stage biotechnology company dedicated to advancing immunology therapies with next-generation antibodies targeting α4β7, TL1A, IL-23, and IL-17A/F, alongside rational combination programs.

Role Summary:

The Senior Director, Drug Safety and Pharmacovigilance (DSPV) Operations will lead operational pharmacovigilance activities, including case management, vendor governance, regulatory compliance, PV Quality Management System (QMS), inspection/audit readiness, training, and performance metrics. This role oversees DSPV contracts, budgets, and invoices while serving as the subject matter expert for outsourced safety operations, managing Argus global safety database (GSDB) workflows, reporting, and disaster-recovery planning.

Key responsibilities involve ensuring compliance with study protocols, Safety Management Plans (SMPs), Vendor Oversight Plans (VOPs), SOPs, and KPIs. The position reports to the Senior Vice President, Drug Safety and Pharmacovigilance.

Key Responsibilities:

Case Management and Safety Systems

• Oversee end-to-end case processing for clinical programs, ensuring timely, accurate, and compliant safety information collection, review, and reporting.
• Lead Argus GSDB workflows, vendor activities, reporting, compliance, and business continuity.
• Manage expedited safety reporting (e.g., SUSAR submissions) per regulatory timelines.
• Establish and monitor case-processing workflows, KPIs, and compliance metrics.
• Monitor vendor/partner compliance with protocols, SOPs, contracts, and regulations.
• Act as the unblinded Drug Safety Operations representative when required.

Vendor and Operational Governance

• Lead operational oversight of DSPV vendors, service providers, and business partners, defining roles, deliverables, and escalation pathways.
• Participate in Safety Management Team (SMT) meetings and vendor governance forums.
• Develop and maintain SOPs, workflows, and operational plans collaboratively.
• Oversee SMPs, VOPs, budgets, contracts, and invoices.

Safety Data, Surveillance, and Reporting

• Reconcile safety data with Data Management, Clinical CROs, and stakeholders.
• Collaborate on safety-data review, analysis, and reporting with Safety Physicians, Regulatory Affairs, Biostatistics, and vendors.
• Prepare safety reports, listings, narratives, and DSURs for regulatory submissions.
• Support health authority responses and 6-month line listings (6MLLs).
• Contribute to Clinical Study Reports (CSRs) and Data Monitoring Committee (iDMC) meetings.
• Assist in Safety Advisory Committee meetings.

Quality, Compliance, and Inspection Readiness

• Oversee and improve the DSPV Quality Management System (QMS) with Quality Assurance.
• Ensure audit and inspection readiness for DSPV activities and vendors.
• Lead CAPA (Corrective and Preventive Action) remediation and compliance improvements.
• Serve as the PV compliance subject matter expert for inspections.

Systems, Documentation, and Business Continuity

• Organize and maintain DSPV documentation in SharePoint and electronic trial master files.
• Partner with IT to ensure data security, protection, and system continuity for GSDB.
• Develop and test business-continuity and disaster-recovery plans.

Training

• Lead development of the DSPV training curriculum aligned with SOPs and regulations.
• Oversee vendor training programs and compliance.

Other

• Perform additional duties as assigned.

Ideal Candidate:

• Master’s degree in Life Sciences (preferred: RN or PharmD).
• Minimum of eight years of experience in pharmacovigilance operations or related roles in biotech/pharma.
• Hands-on experience with global safety databases (preferably Argus) and safety-data analytics.
• Proven expertise in case processing, vendor governance, audit readiness, and budget management.
• Familiarity with ICH guidelines and U.S./EU pharmacovigilance regulations.
• Experience preparing DSURs and 6MLLs.
• Strong analytical and problem-solving skills to interpret complex data.
• Excellent communication and leadership to collaborate across functions.