ARGUS safety system expert - Drug Sagety Manager
About the role
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- 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 PV Safety Systems 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 as they impact the company.
- Ensure all project safety activities are completed in accordance with SOPs, SSPs, and other applicable regulations
- Keep management appraised of any potential/actual study or staffing issues and assist with developing solutions
- Coordinate and implement department training and identify training needs; provide Medical Affairs and Drug Safety training to other departments as requested
- Maintain quality review metrics and attend other project quality meetings as required
- Supervise maintenance of project drug safety files as regionally applicable
- Minimum 3-5 years of experience within Pharmacovigilance required, including at least 2 years of experience with Argus Safety systems and applications
- Understanding of FDA/EMA regulations supporting the submission of adverse events for post-marketing and investigative drugs
- Understanding of ICH guidelines , MedDRA structure Understanding and application of guidelines detailed in FDA 21 CFR Part 11, including system validation requirements
- Advanced skills in report generation using business intelligence tools (Argus Safety Database)
- Advanced understanding of database architecture (Argus Safety Database)
- Ability to troubleshoot complex problems, involve multiple teams/departments in the investigation and assessment of the problem and proposed solutions.
- Ability to exhibit project management skills
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