Head Drug Safety Infrastructure and Data Management - Zurich

Ort: Switzerland - Glattbrugg/Zurich

Funktion: Drug Safety/Pharmacovigilance

Firma: Vifor Pharma

Georgia Izzat

International Talent Acquisition Specialist

+41 58 851 83 78

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Ihr Profil

Do you bring subject matter expertise working with the ARISg Drug Safety Database? 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 Safety Infrastructure and Data Management. Your task and responsibilities will include, but not be limited to, the following:

Infrastructure Management – Aris Global Managed Services (AGMS)

  • Lead and support Drug Safety IT systems related problem solving
  • Manage vendor for ARISg user support and enhancements
  • Act as Business Owner of the system, sign-off related deliverables, ensure appropriate documentation
  • Ensure ICH E2B (R2) standards are met, prepare system and procedures for ICH E2B (R3) implementation
  • Manage the ESTRI Gateway and E2B reporting, keep up with regulatory system requirements (e.g. EudraVigilance, Swissmedic and US FDA)
  • Lead E2B testing with current and new trading partners
  • Manage regular updates of the medical dictionaries in the Drug Safety database and ensure all Global Drug Safety users are appropriately trained
  • Ensure medical coding conventions and procedures are up-to-date and appropriate according to the internal and external requirements
  • Participate in the user community of the safety system / MedDRA / WHO-Drug Dictionary
  • Liaise with internal and external stakeholders concerning safety database related Topics

Data Management

  • 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 standardized 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

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 operations including: case classification, causality, labelling, MedDRA, WHO-
  • 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.

Über uns

Die Vifor Pharma Gruppe – die frühere Galenica Gruppe – ist ein globales Spezialitäten-Pharmaunternehmen, das eigene Pharmaprodukte erforscht, entwickelt, herstellt und vertreibt und ein bevorzugter Partner für innovative patientenorientierte Lösungen ist. Das Unternehmen hat sich zum Ziel gesetzt, ein globaler Marktführer in den Bereichen Eisenmangel, Nephrologie und kardiorenale Therapien zu sein und weltweit Patienten mit schweren und chronischen Erkrankungen zu einem besseren Leben in Gesundheit zu verhelfen. Die Vifor Pharma Gruppe verfügt über Produktionsstätten in der Schweiz und in Portugal sowie über ein dynamisches Netzwerk von Vertriebsgesellschaften und Partnern zur weltweiten Marktabdeckung. Das Unternehmen treibt die Expansion seiner weltweiten Präsenz laufend voran, bleibt dabei aber in seinem schweizerischen Heimmarkt fest verwurzelt.

Die Vifor Pharma Gruppe besteht aus Vifor Pharma, Vifor Fresenius Medical Care Renal Pharma, ihrem gemeinsamen Unternehmen mit Fresenius Medical Care, Relypsa und OM Pharma.

Für mehr Informationen gehen Sie bitte auf: http://www.viforpharma.com/de/über-vifor-pharma/wer-wir-sind

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