Senior Director, Drug Safety and Pharmacovigilance Operations

The role

The Senior Director, Drug Safety and Pharmacovigilance Operations provides operational leadership for pharmacovigilance activities. This role oversees case management, vendor governance, regulatory compliance, and the PV Quality Management System.

What you will do

• 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, and compliance metrics.
• Monitor safety operations performed by PSPs, vendors, and business partners.
• Provide operational leadership and oversight of DSPV vendors, service providers, consultants, and business partners.
• Lead or participate in SMTs, vendor governance meetings, and cross-functional program teams.
• 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.
• Oversee and continuously improve the DSPV QMS.

Required qualifications

• Master’s degree in relevant field (Life sciences) or equivalent combination of education and experience
• 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
• 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)

Nice to have

• nursing degree (RN)
• pharmacy degree (PharmD)
• Argus

Benefits

• Market competitive compensation and benefits package
• performance bonus
• equity grant opportunities
• health, welfare & retirement benefits
• Unlimited PTO
• Two, one-week company-wide shutdowns each
• professional development opportunities

About the company

Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology. Their pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, IL-23, and IL-17A/F as well as rational combination programs.