Director, PV Systems

Company

Ionis is a biopharmaceutical company focused on RNA-targeted medicines, gene editing, and treatments for serious diseases.

What you will do

• Translate PV operational requirements from Case Management, Submissions, Surveillance, Inspection Readiness, and Governance teams into vendor-ready system specifications.
• Oversee Argus Safety, E2B(R3) submission infrastructure, agency gateways, and submission queue health across regulatory jurisdictions.
• Lead user acceptance testing, Computer Systems Validation, change control, configuration documentation, and output verification for PV system changes.
• Manage relationships with Argus, E2B gateway, MedDRA/WHODrug, and other PV technology vendors, including CAPA resolution and implementation reviews.
• Develop a three-year PV technology roadmap and oversee data governance, privacy, access controls, business continuity, and disaster recovery planning.
• Support inspections, audits, KPI development, staff readiness, and compliance with applicable pharmacovigilance requirements.

Requirements

• Bachelor’s degree in life sciences, information technology, computer science, data science, or a related field.
• 8+ years of experience in pharmaceutical or biopharmaceutical pharmacovigilance operations, safety systems, or regulated technology.
• 5+ years of hands-on experience with pharmacovigilance systems and safety databases, particularly Argus Safety.
• Experience implementing and validating enterprise systems, managing vendors, and applying CSV, GAMP5, or comparable regulated-system methodologies.
• Knowledge of E2B(R2)/(R3), FDA and EMA gateway requirements, MedDRA, WHODrug, ICH guidelines, 21 CFR Part 11, Annex 11, GxP change control, and GDPR.
• Experience writing UAT scripts and functional specifications, supporting regulatory inspections, and leading cross-functional initiatives; willingness to travel 10–15% annually.

Nice to have

• Advanced degree.
• Exposure to UltraIntake, Empirica Signal, UltraAnalytics, Veeva Vault Safety, or EDC integrations.

Culture & Benefits

• Work alongside teams focused on scientific innovation and improving outcomes for patients with serious diseases.
• Operate in a challenging and collaborative environment supporting innovation and scientific excellence.
• Access an excellent benefits package.
• Compensation range: $202,235–$268,875 annually.