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ARGUS safety system expert - Drug Sagety Manager

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About the role

This vacancy has now expired. Please click here to view live vacancies.
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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