Associate Director - Pharmacovigilance Technology Lead

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!

Associate Director - Pharmacovigilance Technology Lead

SUMMARY :

We are seeking an experienced Associate Director – Pharmacovigilance (PV) IT Systems to lead the technology strategy, operations, and evolution of our 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

• Bachelor’s or master’s degree in computer science, Life Sciences, Information Technology, or a related field.
• 10–15 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.

Benefits

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