DRUG SAFETY ASSOCIATE - ZURICH

Ort: Switzerland - Glattbrugg/Zurich

Funktion: Drug Safety/Pharmacovigilance

Firma: Vifor Pharma

Kira Maurer

Junior Talent Acquisition

+41 58 851 83 48

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Ihr Profil

We are currently looking for a Drug Safety Associate to join our Global Drug Safety Team at our Operational Headquarter in Zurich. Reporting to the Global Head Drug Safety Case Management, you will be responsible for various activities of safety data processing, reporting and presentation of data. You will liaise with internal and external stakeholders, including partners, consultants and service providers. Your tasks and responsibilities will include, but not be limited to, the following:

  • Efficient and consistent processing of all adverse event reports from different sources (spontaneous, clinical trial, literature and others)
  • Performing triage of safety reports and case processing of safety data received from worldwide sources (spontaneous, clinical trial, literature and others)
  • Ensuring appropriate tracking of inbound and outbound communication related to individual safety cases
  • Ensuring consistency in case classification, causality, labelling, MedDRA, WHO-Drug coding, narratives
  • Managing expedited reporting and ensuring compliance for both spontaneous and clinical reports
  • Ensuring that reporting of spontaneous and  clinical study cases are handled appropriately and reporting is in compliance with regulations to Health Authorities, Ethical committees and External Safety Review Boards
  • Coordination of case follow-up activities and reconciliation of safety reports with Health Authorities / Contractual Partners/CRO’s
  • Liaising with Other Drug Safety Associates regarding their case processing tasks (medical evaluation, Quality Control)
  • Liaising with affiliates and partners for expedited reporting compliance
  • Liaising internally and externally with other departments, consultants, partners, service providers regarding case management activities
  • Presentation of safety data (spontaneous and clinical)
  • Performing Reconciliation of Spontaneous cases with partners and affiliates in accordance with Safety Data Exchange Agreements
  • Liaising with Quality Assurance in handling Product Technical Complaints associated with adverse events or received initially by Drug Safety
  • Ensuring procedures for PV Quality Control
  • Ensuring that Standard Operating Procedures for drug safety are up to date and in line with applicable regulations. Ensuring compliance with SOPs

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

  • 1-2 years working experience in post marketing surveillance/drug safety operations including: case classification, causality, labelling, MedDRA, WHO
  • Drug coding and narratives
  • Fluency in English, additional language skills in German or French are preferred
  • Excellent user of Microsoft Office (Word, Excel, PowerPoint, Outlook)
  • Experience in drug safety database, preferably ARISg
  • Experience in audits and inspections is preferred
  • EudraVigilance certification is preferred

You have strong communication skills orally and in writing and good analytical skills. You have good life science, pharmaceutical and medical  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: http://www.viforpharma.com/de/über-vifor-pharma/wer-wir-sind

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