[Hiring] Senior Director, Drug Safety and Pharmacovigilance Operations @Spyre Therapeutics

Role Description

The Senior Director, Drug Safety and Pharmacovigilance (DSPV) Operations will provide operational leadership for pharmacovigilance activities, including:

• Case management
• Vendor governance
• Regulatory compliance
• PV Quality Management System (QMS)
• Inspection and audit readiness
• Training
• 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
• Activities related to the Argus global safety database (GSDB)

Responsible for reports preparation and vendor management for GSDB related activities, this role serves as lead for:

• PV compliance
• QMS
• Inspection/audit readiness for the DSPV function
• 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
• Business partners

This position reports to the Senior Vice President, Drug Safety and Pharmacovigilance.

Qualifications

• Master’s degree in 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

Requirements

• Provide oversight of end-to-end case processing for clinical development programs
• Serve as the operational subject matter expert and lead for the Argus global safety database
• Oversee expedited safety reporting, including SUSAR submissions
• Establish and monitor case-processing workflows, KPIs, compliance metrics, and operational deliverables
• Monitor safety operations performed by PSPs, vendors, and business partners for compliance
• Provide operational leadership and oversight of DSPV vendors
• Lead or participate in SMTs, vendor governance meetings, and other safety governance forums
• Develop and maintain operational plans, SOPs, work instructions, workflows, and other DSPV processes
• Manage DSPV vendor and consultant budgets, contracts, statements of work, change orders, and invoices
• Oversee safety-data reconciliation with Data Management, Clinical CROs, and other stakeholders
• Prepare and oversee safety reports, listings, narratives, and other data outputs
• Maintain audit and inspection readiness for DSPV activities, systems, vendors, and business partners
• Oversee CAPAs, remediation activities, and compliance improvements related to DSPV operations
• Oversee the organization, completeness, and maintenance of DSPV documentation
• Lead development and maintenance of the DSPV training curriculum

Benefits

• Opportunity to work in a fast-paced, dynamic environment
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• Unlimited PTO
• Two, one-week company-wide shutdowns each year
• Commitment to provide professional development opportunities
• Remote working environment with frequent in-person meetings
• The expected salary range offer for this role is $295,000 to $311,000