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We are currently looking for a Drug Safety Associate (Infrastructure and Data Management) to join our Global Drug Safety Team at our Operational Headquarter in Zurich. This position is limited to 12 months. Reporting to the Head Global Drug Safety Technologies, you will be responsible for collaborating with the ARIS Global Managed Services Team, maintain the validated state of Drug Safety database to ensure compliance to regulatory standards, maintain reporting requirements and data entry conventions as per regulatory requirements and procedures, assist in implementation, upgrade, enhancement of the Drug safety database, and support appropriate presentation of drug safety data for signal detection, benefit-risk assessment and aggregate reporting. Your tasks and responsibilities will include, but not be limited to, the following:

Systems and Data Management:

• Administration of the Drug Safety database (management and maintenance of database libraries, code lists and user accounts) with the support of the ARIS Global Managed Services team
  


• Collaborate with ARIS Global Managed Services team (user support, incident management, configuration changes)
  


• Support database querying activities (requirements definition, reports validation) monitoring the quality of the data outputs and process efficiency
  


• Support maintenance and enhancements of the applied drug safety systems (e.g. safety database, SharePoint sites, shared drive locations, dedicated mailbox)
  


• Support the Drug Safety Case Management team in regular process enhancements for better compliance and efficiency
  


• Support the safety database users (internal and contracted) on technical questions
  


• Maintain Standard Operating Procedures (business administration, data management)
  


• Support the appropriate documentation of the drug safety systems and data management
  


• Support (testing, validation) the implementation of new solutions for drug safety
  


• Support data cleaning activities

The ideal candidates is holding a university degree in a Life Sciences field in addition to the following experience:

• Bachelor degree in pharmacovigilance / other life sciences / data management or information systems related sciences (Master degree preferred)
  


• 2-3 years’ working experience in drug safety / pharmacovigilance area
  


• 1-2 years’ working experience with validated drug safety databases (ARISg preferred), experience with data management is beneficial
  


• Good knowledge of pharmacovigilance legislations
  


• Fluency in English
  


• Excellent user of Microsoft Office (Word, Excel, PowerPoint, Outlook, SharePoint)
  


• Affinity with Information Technology, quick learner in new applications
  


• Experience with Business Objects and SQL is preferred
  


• Experience with computerised systems validations (GAMP 5), Quality Management, procedural documents, compliance metrics, PV training, audits and inspections, CAPA management is beneficial
  


• Project management training / experience is beneficial

You have strong communication skills orally and in writing and good analytical skills. You have good life science and pharmaceutical knowledge, with substantial knowledge in drug safety. You are organised in your approach, with a good sense for prioritisation and the identification of critical situations from a drug safety perspective. You are a team player and are able to maintain good working relationships and are capable coordinating with service providers and worldwide partners. You work in line with the Vifor Pharma values. You have proactive and problem-oriented attitude. You take responsibility over your tasks and committed to deliver results.

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: www.viforpharma.com/de/ueber-vifor-pharma/wer-wir-sind

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