Clinical Safety & Pharmacovigilance
Manager, Data Systems
Office Location: San Diego, CA
Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
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.
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.
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)
Preferred
- Previous experience with Argus Database implementation in a client hosting and management setting
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.