Head Drug Safety Data and Infrastructure Management
Vifor Pharma
Switzerland - Glattbrugg-Zurich
vor 21 Std.

Votre profil

Do you bring subject matter expertise in Drug Safety Data Management? Do you enjoy managing teams and external service providers?

If yes, we have a great opportunity for you to join our Global Drug Safety team at our Operational Headquarters in Glattbrugg.

We are seeking a Head Drug Data Management reporting directly to the Global Head of Medical & Clinical Drug Safety. Your task and responsibilities will include, but not be limited to, the following :

  • Act as lead expert for data management in the ARISg projects, perform data cleaning related to the version change, data migration and data entry conventions updates
  • Maintain Standard Operating Procedures for data management, including data entry conventions, standardised searches, reports and data cleaning
  • Manage the data entry conventions for safety database in line with the most recent regulatory requirements
  • Regularly train ARISg users (internal and contracted) on data entry conventions and validations
  • Retrieve and present drug safety data for signal detection / Health Authority responses / reconciliation / aggregate safety reports purposes in a standardised and documented manner
  • Correct and respond to Health Authority data quality reports
  • Provide monthly reporting and case statistics, provide regular and ad hoc search results
  • Lead managing, defining and validating the Business Objects reports (create
  • User Requirement Specifications, execute validation scripts, manage validation documentation) and ensure safe user access and execution
  • Ensure ICH E2B (R2) standards are met, prepare system and procedures for ICH E2B (R3) implementation
  • Manage regular updates of the medical dictionaries in the Drug Safety database and ensure all Global Drug Safety users are appropriately trained
  • Participate in the user community of the safety system / MedDRA / WHO-Drug Dictionary
  • Team management responsibilities for three externals
  • The ideal candidates is holding a university degree in a pharmaceutical or information systems related in addition to the following experience :

  • Minimum of 3-5 years of working experience in post marketing surveillance / drug safety / data management
  • Drug coding and narratives / data management field including : EudraVigilance, E2B, custom reports, validation
  • Experience with drug safety databases (especially ARISg), E2B, Business Objects, good understanding of aggregate reporting;
  • benefit-risk assessment; signal detection and risk management

  • Experience in PV Quality Management, procedural documents, compliance metrics, PV training, audits and inspections, CAPA management
  • People management training / experience
  • Fluency in English
  • Excellent user of Microsoft Office (Word, Excel, PowerPoint, Outlook)
  • You have strong communication skills orally and in writing and good analytical skills. You are organised and accurate in your approach, with a good sense for prioritisation and the identification of critical situations from a drug safety perspective.

    You are able to maintain good working relationships with affiliates and headquarters employees, work effectively in cross-

    functional teams. You work in line with the Vifor Pharma values.

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