DRUG SAFETY ASSOCIATE (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

Richtlinien für Agenturen

Ihr Profil

We are currently looking for a Drug Safety Associate (Data Management) to join our Global Drug Safety Infrastructure & Data Management Team. Reporting directly to the Head Drug Safety Infrastructure & Data Management, you will be responsible for the management of the ARIS Global Managed Services team and maintain the validated state of the Drug Safety database, to ensure compliance with regulatory standards. Your tasks and responsibilities will include, but not be limited to, the following:
  • Administration of the Drug Safety database (management and maintenance of libraries, codelists, users, dictionaries) with the support of the ARIS Global Managed Services team.
  • Manage and oversee the ARIS Global Managed Services team activities (user support, incident management, configuration changes).
  • Ensure appropriate documentation of the ARIS Global Managed Services team activities.
  • Support maintenance and enhancements of all ARISg modules, ESTRI gateway etc.
  • Regularly train ARISg users (internal and contracted) on data entry conventions and validations.
  • Manage database validations and regularly screen database for discrepancies.
  • Manage the data entry conventions for safety database in line with the most recent regulatory requirements.
  • Support data cleaning activities, define major elements for regular data cleaning activities.
  • Support database querying activities (requirements definition, reports validation) monitoring the quality of data outputs and process efficiency.
  • Assist in implementation of new solutions for drug safety.
  • Support the Drug Safety Case Management team in regular process enhancements.
  • Maintain Standard Operating Procedures (business administration, data management).
The ideal candidates is holding a university degree (preferably a Masters degree) in pharmacovigilance / other life sciences / data management or information systems related sciences in addition to the following experience:
  • 2-3 years working experience in post marketing surveillance / drug safety
  • 1-2 years working experience with validated drug safety databases, data management field including: EudraVigilance, E2B, custom reports, validation
  • Good knowledge of pharmacovigilance regulation
  • Fluency in English
  • Excellent user of Microsoft Office (Word, Excel, PowerPoint, Outlook), experience with MS SharePoint, Business Objects and SQL is preferred
  • Experience in drug safety database application maintenance, preferably ARISg
  • Experience with computerised systems validations (GAMP 5), Quality Management, procedural documents, compliance metrics, PV training, audits and inspections, CAPA management is preferred
You bring good interpersonal skills with a problem and conflict solving attitude. You have strong communication skills orally and in writing and good analytical skills. You are organised in your approach, with a good sense for prioritisation and the identification of critical situations from a drug safety perspective. You work effectively in cross-functional teams, with the ability to develop good working relationships with service providers and global partners.

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

Inhalt ein-/ausblenden

Bewerben
Teilen
LinkedIn Xing Send to a friend

Richtlinien für Agenturen