Associate Director - Pharmacovigilance Technology Lead

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 10–15 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

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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