Director, PV Systems

Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We’re pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs.  With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals.

At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees. 

With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive. 

We’re building on our rich history, and we believe our greatest achievements are ahead of us. If you’re passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career!

DIRECTOR, PV SYSTEMS

SUMMARY: 

The Director, PV Systems is a senior techno-functional leader embedded within Patient Safety & Pharmacovigilance (PV) Operations at Ionis. This role serves as the primary bridge between PV business operations and the external vendors responsible for maintaining and implementing Ionis's PV technology stack — including Argus Safety, UltraIntake, Empirica Signal, UltraAnalytics, and E2B(R3) submission infrastructure. Reporting to the Executive Director of PV Operations, the Director translates PV operational requirements into systems strategy, leads vendor partnerships, drives the technology roadmap, and establishes data governance and system validation frameworks. This is not a system administration role — the vendor manages the technical infrastructure — but the Director ensures the vendor understands PV operational requirements, delivers them accurately, and that PV Operations is fully equipped to use what the vendor builds. The role functions as an internal SME, maintaining inspection readiness and compliance while enabling Ionis's safety oversight and regulatory obligations.

KEY RESPONSIBILITIES: 

Business Requirements & Process Alignment 

• Work with Case Management, Submissions, Surveillance, Inspection Readiness, and PV Governance teams to identify system-related pain points and translate them into prioritized, clearly documented change requests for vendors.
• Document current-state PV workflows and map them against system capabilities; surface gaps where the system does not support the process and propose solutions in collaboration with the vendor.
• Support PV leadership in building the business case for system changes, upgrades, or new tool implementations by providing process-informed technical context.
• Maintain working knowledge of system configuration across all PV platforms — not to configure them directly, but to accurately specify, review, and validate what the vendor configures.
• Lead cross-functional initiatives to address system scalability gaps, including automated case intake, auto-submission capabilities, and AI risk governance.

Submission Infrastructure Oversight 

• Maintain functional knowledge of Argus submission configurations — scheduling rules, due date logic, E2B(R2)/(R3) transmission profiles, and agency gateway setups (FDA ESM/eSubmitter, EMA EVWEB/EudraVigilance, MHRA, PMDA) — sufficient to review vendor setup and identify misconfiguration.
• Oversee E2B(R3) gateway and submission infrastructure to ensure electronic submission capabilities meet regulatory requirements across all jurisdictions.
• Monitor submission queue health and transmission logs; identify systemic issues or recurring errors and work with the vendor to resolve root causes, not just symptoms.
• Coordinate with the PM Submissions & CAPA Manager to ensure submission infrastructure is aligned with operational timelines and regulatory reporting obligations.
• Flag submission configur