Spyre Therapeutics

Director

• Perform triage and medical review of Individual Case Safety Reports (ICSRs)
• Oversee cases and Analysis of Similar Events (AOSEs) for expedited safety reporting
• Lead cross-functional medical review discussions
• Prepare, write, and review aggregate safety documents such as DSURs
• Review scientific literature and prepare written summaries supporting aggregate safety analyses
• Participate in safety data review, surveillance, signal detection, and signal management
• Present cases at safety management and safety review team meetings
• Co-lead safety surveillance and signal management meetings
• Participate in process improvement projects related to medical review, safety surveillance, and pharmacovigilance compliance
• Assist in developing and maintaining pharmacovigilance processes, SOPs, work instructions, safety management plans, and safety surveillance plans
• Develop safety presentations for independent Data Monitoring Committee meetings
• Collaborate with the Medical Review Lead and other physicians on case review and unified medical review approaches
• Lead epidemiology projects relevant to safety and pharmacovigilance
• Ensure activities meet quality, accuracy, timeliness, and global regulatory requirements
• Provide medical safety strategy and execute benefit-risk management strategies
• Provide safety input to clinical development plans and responses to health authority or ethics committee queries
• Develop safety risk language and risk management strategies
• Support pre-filing safety activities, integrated safety reviews, and safety-focused publications
• Perform other duties as assigned
• Report to the Senior Vice President of Drug Safety and Pharmacovigilance, with a dotted-line relationship to the Medical Review Lead

Director, Drug Safety

Operations

• 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

Director, Drug Safety

Senior Director, Drug Safety and Pharmacovigilance Operations