Job Description

Overview

Ionis is seeking an experienced Associate Director Pharmacovigilance (PV) IT Systems to lead the technology strategy, operations, and evolution of the PV technology ecosystem. This individual will be a critical liaison between IT, pharmacovigilance business stakeholders, and third-party vendors, ensuring robust, compliant, and future-ready PV systems. The ideal candidate brings 1015 years of hands-on experience with Oracle Argus Safety, Empirica signaling system, PV integrations, Axway Gateway, and a strong grasp of PV IT architecture.

Responsibilities

• Application Ownership & Governance
• Provide oversight of Argus application to ensure alignment with IT security, compliance, and infrastructure standards.
• Maintain IT policies and procedures related to Argus, including change control, validation, and audit readiness.
• Vendor & SLA Management
• Act as the primary IT liaison with outsourced service providers.
• Ensure vendors meet agreed SLAs and deliver high-quality service.
• Manage escalations, upgrades, and maintenance activities.
• Compliance & Risk Management
• Support validation activities and ensure compliance with global regulatory requirements.
• Oversee system access control, data security, and disaster recovery planning.
• Participate in audits and inspections related to Argus.
• Integration & Process Optimization
• Lead IT efforts in integrating Argus with internal and external systems.
• Support automation initiatives to enhance efficiency in case processing.
• Collaborate with business and IT teams to align Argus functionality with organizational needs

Requirements

• Bachelors or masters degree in computer science, Life Sciences, Information Technology, or a related field.
• 1015 years of experience in PV IT with strong expertise in Oracle Argus Safety Suite (v8.x or above).
• Proven experience with Argus integrations, Empirica Signaling, E2B (R2/R3) message processing, Axway Gateway, and PV data exchange protocols.
• Solid understanding of PV business processes, case processing workflows, and global safety reporting obligations.
• Pharmacovigilance System Knowledge & Compliance (GxP, CFR Part 11, EMA, MHRA, FDA Regulations)
• Vendor Management & SLA Oversight
• Data Migration & Integration Expertise (Oracle, SQL, APIs, ETL Tools)
• Experience with system validation (CSV), GxP, 21 CFR Part 11, and data integrity principles.
• Strong knowledge of technical architecture, middleware, APIs, and system interoperability.
• Familiarity with cloud-hosted Argus environments and managed services models.
• Ability to collaborate across business and technical teams, with strong vendor and stakeholder management skills.
• Excellent communication, documentation, and leadership capabilities.

Note : This description reflects the content of the original posting and includes the information necessary to understand the role and requirements.

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