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ARGUS safety system expert - Drug Sagety Manager

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About the role

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Argus Safety System analyst will provide line management of Drug Safety, Systems and Administrative staff assigned.

Key Responsibilities include:
  • 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 
Skills Required:

  • 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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