Manager, Data Systems

Arrowhead Pharmaceuticals • San Diego, CA

2h

About The Position

The Manager, Data Systems is responsible for the day‑to‑day management, maintenance, and operational support of Clinical Safety and Pharmacovigilance data systems, including the Argus Safety Database. This role supports system configuration, testing, validation, performance monitoring, and data quality activities. The Manager ensures reliable system functionality, participates in system upgrades and enhancements, and provides essential data and technical support to the Drug Safety team.

Requirements

• Minimum BS Computer Science/ equivalent qualification
• 5 years of experience working with Argus Safety database
• Work experience with Oracle Argus versions 8.2 and higher is required.
• Experience with Electronic Data Interchange (Axway B2Bi interchange) is required.
• Knowledge of ICH E2B guidelines in clinical and post-marketing studies.
• Good organizational skills with the ability to perform multiple tasks efficiently and effectively
• Proficiency in standard desktop software programs (Word, Excel, Outlook)

Nice To Haves

• Previous experience with Argus Database implementation in a client hosting and management setting

Responsibilities

• Responsible for full development cycle of Planning, Analysis, Design, Development, Testing and Implementation of Argus Safety Database.
• Responsible for Argus console activities like maintaining user sites, groups, accounts, workflow, product, study configurations, and reporting rules.
• Perform periodic MedDRA and WHO Drug upgrades.
• Responsible for the design, creation, and execution of IQ, OQ an PQ scripts.
• Responsible for data migration from vendor Argus database.
• Responsible for managing day to day operation of Argus safety database.
• Responsible for day-to-day system operations including user support, upgrades/patches, system enhancements, auto-populate and post-save functionalities.
• Responsible for setup and maintenance of Argus code lists, company product directory, and datasheets.
• Lead integration of other databases and tools with Argus (e.g., clinical database, PV intake tools, PV reporting tools or PV signaling tools.
• Perform and lead periodic Disaster recovery and Business continuity tests as needed.
• Support Drug Safety team with listings and data from the Argus database.
• Oversight over Argus performance and maintenance.
• Assist with Drug Safety audits and inspections with system validation requirements and data required from Argus.
• Author and maintain Drug Safety Systems related SOPs and WIs.

Benefits

• Arrowhead provides competitive salaries and an excellent benefit package.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager