Director, PV Systems

Ionis•Carlsbad, CA

7d•Hybrid

About The Position

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.

Requirements

Bachelor's degree in life sciences, information technology, computer science, data science, or related field; advanced degree a plus.
8+ years of experience in pharmaceutical or biopharmaceutical PV operations, safety systems, or technology in a regulated environment.
5+ years of direct, hands-on experience with pharmacovigilance systems and safety databases — particularly Argus Safety — including techno-functional, business analyst, or systems liaison responsibilities within a PV or drug safety function.
5+ years of experience implementing, validating, and maintaining large-scale enterprise systems in regulated environments.
3+ years of experience in vendor management, technology partnerships, or outsourced operations oversight.
3+ years of experience with Computer Systems Validation (CSV), GAMP5, or similar regulated system development methodologies.
Strong functional knowledge of Argus Safety — including Console configuration concepts, Interchange/E2B setup, workflow rules, submission scheduling, and case form structure — sufficient to review vendor configurations and identify issues without performing the configuration directly.
Demonstrated experience with E2B(R2)/(R3) submission standards and agency gateway requirements (FDA ESM, EMA EVWEB/EudraVigilance, MHRA, PMDA).
Working knowledge of MedDRA and WHODrug coding standards, dictionary management processes, and version control governance.
Solid understanding of ICH E2A, E2B(R3), FDA 21 CFR Part 314/600, and EMA GVP Module VI requirements as they apply to system configuration and submission setup.
Working knowledge of GxP change control, 21 CFR Part 11, Annex 11, and GDPR requirements for computerized systems in a regulated environment.
Experience writing UAT test scripts, business requirements documents, or functional specifications for PV system changes.
Experience supporting regulatory inspections and maintaining inspection readiness documentation.
Strong communicator — able to explain technical system behavior in plain language to PV operations staff, and articulate PV process requirements in precise technical terms to vendors.
Strategic thinker with a process-first mindset; instinctively evaluates system capabilities against operational workflow and long-term organizational needs.
Comfortable operating in a vendor-managed model — able to hold vendors accountable to business requirements without needing to control the technical implementation directly.
Organized and proactive in tracking open items, follow-ups, and change requests across multiple concurrent workstreams.
Strong project management, cross-functional leadership, and executive communication capabilities.

Nice To Haves

Exposure to the broader PV IT landscape (UltraIntake, Empirica Signal, UltraAnalytics, Veeva Vault Safety, EDC integrations) is a plus.

Responsibilities

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.
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 configuration risks ahead of new product launches, market entries, or regulatory changes requiring system updates.
Own user acceptance testing (UAT) on behalf of PV Operations for all Argus and PV system changes — including vendor-delivered configurations, upgrades, patches, and new module implementations.
Develop UAT test scripts grounded in real PV operational scenarios: case intake, workflow routing, submission scheduling, E2B transmission, late case management, and CAPA tracking; ensure coverage reflects actual regulatory use cases, not just technical functionality.
Document UAT outcomes, defects, and sign-off decisions; communicate results clearly to vendors and PV leadership before any change is promoted to production.
Drive Computer Systems Validation (CSV) program completion to ensure 21 CFR Part 11 and Annex 11 compliance across all PV systems.
Maintain change logs and configuration documentation for all system updates; ensure records meet GxP change control and audit trail requirements.
Coordinate with IT and vendor on release schedules and maintenance windows to minimize disruption to case processing and submission timelines.
Review outputs generated by PV systems — including data listings, case counts, submission metrics, and periodic reports — to confirm they meet agreed business and regulatory standards before use in decision-making or submissions.
Verify accuracy and completeness of data in validated listings by cross-checking system outputs against source data, configuration specifications, and expected results; escalate and track discrepancies through to resolution.
Establish and maintain output acceptance criteria in collaboration with PV Operations, Quality, and Regulatory Affairs to define what constitutes a compliant, fit-for-purpose system output.
Maintain documentation of output verification activities as part of the broader CSV and GxP compliance record.
Serve as the primary day-to-day point of contact between PV Safety Operations and external system vendors (Argus, E2B gateways, MedDRA/WHODrug, and other PV IT platforms).
Translate PV operational requirements — workflow needs, submission schedules, case processing rules, reporting configurations — into clear, actionable technical specifications for vendor implementation.
Review vendor-proposed system configurations, change requests, and implementation designs; assess alignment with PV business processes and flag gaps or risks before any change reaches production.
Manage CAPAs with technology partners to address identified deficiencies or gaps in system performance or compliance.
Participate in vendor calls, change advisory meetings, and implementation reviews as the PV Operations SME; escalate unresolved issues to PV leadership with a clear summary and a recommended position.
Maintain a running log of open vendor items, change requests, and system issues; track resolution timelines and ensure nothing falls through the gaps between PV Operations and vendor teams.
Develop and maintain a 3-year PV Technology Roadmap in partnership with IT, defining system priorities and investment decisions across Argus, UltraIntake, Empirica Signal, and UltraAnalytics.
Advise PV leadership on emerging technologies, regulatory trends such as E2B(R3) enhancements, AI governance, and data privacy to inform PV systems strategy.
Oversee data governance frameworks that define data ownership, quality standards, and traceability requirements for PV systems in partnership with IT.
Manage MedDRA/WHO-DD dictionary governance and version control to ensure consistent coding and data quality across PV systems.
Ensure data privacy and PII governance aligned with GDPR, FDA, and EMA requirements across all PV systems and processes.
Define and maintain business continuity and disaster recovery plans for PV systems in partnership with IT to ensure operational resilience.
Oversee user access controls and account management to ensure appropriate role-based permissions and security governance across PV systems.
Partner with Quality and Regulatory Affairs as subject matter expert for PV systems inspections and audits.
Ensure system documentation including data flows, architecture, validation evidence, and change logs is current and reflects operational state to support inspection readiness.
Define and monitor KPIs that measure system performance, compliance status, and inspection readiness.
Maintain deep knowledge of PV regulatory requirements including FDA 21 CFR Part 11, EMA Annex 11, and ICH E2A-E2F to ensure systems remain compliant with safety process requirements.
Lead business readiness activities for major system implementations to ensure PV staff training and organizational alignment.