Associate Director - Pharmacovigilance Technology Lead
Ionis Pharmaceuticals, Inc.
Full-time
Remote friendly (Boston, MA)
United States
$140,955 - $196,900 USD yearly
IT
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Role Summary
Associate Director – Pharmacovigilance (PV) IT Systems to lead the technology strategy, operations, and evolution of our PV technology ecosystem. Acts as a critical liaison between IT, pharmacovigilance business stakeholders, and third-party vendors to ensure robust, compliant, and future-ready PV systems. Requires 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.
Qualifications
- 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.
Skills
- PV IT systems architecture
- Argus Safety Suite (v8.x+)
- System integrations and data exchange protocols
- Regulatory compliance (GxP, 21 CFR Part 11, EMA/MHRA/FDA)
- Vendor management and contract/SLA oversight
- Validation and data integrity
- Cloud-hosted PV environments
- Cross-functional leadership and stakeholder management
Education
- As listed in Qualifications above (Bachelor’s or Master’s in computer science, Life Sciences, Information Technology, or related fields)
Additional Requirements
- No phone calls.
- Ability to operate in onsite, hybrid, and remote work environments as needed.