Vacancy expired!
Need Technical Consultant / Business System AnalystKey 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.
- 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 database
- Understanding of EMA/FDA regulations supporting the submission of adverse events for post-marketing and clinical studies
- Advanced knowledge of Oracle databases, PLSQL and SQL
- Develop scripts using PL/SQL programing
- Knowledge PHP and ASP + is a plus
- Advanced understanding of Argus Safety Database architecture
- Knowledge of E2B electronic data exchange and Axway Interchange
- Ability to troubleshoot complex problems, involve multiple teams in the investigation and assessment of the problem and proposed solutions
- High level of proficiency with MS Office applications
- Understanding of ICH guidelines
- Understanding 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 concepts
- Basic understanding of documentation requirements (GxP) in a regulated environment
- Basic knowledge of tools used in controlled document environments and tools used in software development
Vacancy expired!