We are looking for Argus Oracle Developer Technical System Analyst to work in Zurich, Switzerland.
- Long-Term Contract: 12 Months + Potential Extension
- Ongoing needs.
- 4+ years experience.
Roles & Responsibilities:
- Support the day-to-day running of applications to sustain Drug Safety objectives, including Argus Safety, MedDRA, Data Warehouse and Business Reporting tools
- Assist with quality review of configuration of Argus Safety System for products, studies, user privileges and workflow.
- Perform programming, validation, and generation of custom reports for data analysis to meet internal business requirements based on contracted timelines
- Understand regulatory changes (EMA/FDA) as they impact the company
- Take part in impact analysis of changes to Drug Safety Systems identifying the risks and benefits associated with the change.
- Review training documentation for Global Drug Safety SOPs related to PV Safety Systems and data management
- Support Global Drug Safety Dictionary version management, such as MedDRA, WHO dictionaries, and upgrades as required by Drug Safety Operations.Act as liaison with IT and vendors to support release and/or patches delivery
- Act as liaison with Business to support ongoing needs of Drugs Safety Operations and partners.
Qualifications and Requirements
- MS in technical field preferred; BS in technical field required
- Minimum 4 years of experience within pharmaceutical industry required, including 1 years of experience with validated Argus safety system implementation
- Technical background and experience related to Argus safety databaseUnderstanding of EMA/FDA regulations supporting the submission of adverse events for post-marketing and clinical studies
- Advanced knowledge of Oracle databases, PLSQL and SQLDevelop scripts using PL/SQL programing
- Knowledge PHP and ASP + is a plusAdvanced understanding of Argus Safety Database architecture
- Knowledge of E2B electronic data exchange and Axway InterchangeAbility to troubleshoot complex problems, involve multiple teams in the investigation and assessment of the problem and proposed solutionsHigh level of proficiency with MS Office applications
- Understanding of ICH guidelinesUnderstanding of MedDRA structure
- Understanding and application of guidelines detailed in FDA 21 CFR Part 11, including system validation requirements, EMA guidelines concerning GVP
- Basic knowledge of scientific terms and medical terminology
- Solid written, verbal communication and interpersonal skills
- Time management and ability to prioritize workload
- Quality orientation: attention to detail, accuracy
- Understanding of training conceptsBasic understanding of documentation requirements (GxP) in a regulated environment
- Basic knowledge of tools used in controlled document environments and tools used in software development
Start date: As soon as possible
Location: Zurich, Switzerland