Drug Safety Associate - Zurich

Ort: Switzerland - Glattbrugg/Zurich

Funktion: Drug Safety/Pharmacovigilance

Senioritätslevel: Specialist

Ihr Profil

Vifor Pharma a world leading Nephrology, Iron Deficiency and Cardio-Renal pharmaceutical company are experiencing rapid growth due to pipeline realization and optimization. We are looking to add a permanent Drug Safety Associate to our team at our HQ in Glattbrugg near Zurich. You will have a grounding in saftey topics such as SAE, compliance and safety case management as well as broader understanding of risk management topics. 

Responsibilities 
  • Coordination of all safety data processing (intake, triage, data
  • entry, QC)
  • Managing expedited reporting and ensuring compliance for both spontaneous and solicited reports
  • Presentation of safety data: spontaneous and solicited
  • Liaison internally and externally with other departments, Consultants, partners, service providers
  • PV Quality control
  • Special duties on assignment
Key Measures of Success 
  • Efficient and consistent processing of all adverse event reports received from
  • worldwide sources (spontaneous, post-marketed study, clinical trial, literature
  • and others)
  • Expedited reporting of individual cases is in line with applicable regulatory
  • requirements and pharmacovigilance contracts; Expedited reporting is fully in compliance (time, channel, format) with the reporting requirements
  • Timely handling of all adverse event reports from different sources as measured by metrics and KPI’s
  • Expedited reporting compliance to health authorities and partners is above defined thresholds
  • ICSR quality is above defined thresholds as defined by applicable KPI`s and metrics
  • Fulfil all legal obligations related to adverse reactions with clinical development projects (Clinical Trial Phase I-IV)
  • All safety data can be presented in a timely and appropriate manner for benefit-risk assessment and aggregate reporting
  • Standard Operating Procedures for drug safety case management are up to date and in line with applicable regulations; processes are in compliance with SOPs
Qualifications 
Minimum requirements
  • University degree in pharmacology / medicine / healthcare/ other life
  • sciences
  • Working experience in post marketing surveillance/drug safety
  • operations including: case classification, causality, labelling, MedDRA,
  • WHO-Drug coding and narratives
  • Fluency in English
  • Excellent user of Microsoft Office (Word, Excel, PowerPoint, Outlook)
Preferred requirements
  • Experience with drug safety databases (especially ARISg)
  • EudraVigilance certification
  • Experience in audits and inspections

Über uns

Die Vifor Pharma Gruppe ist ein globales Spezialitäten-Pharmaunternehmen. Sie hat sich zum Ziel gesetzt, globale Marktführerin in den Bereichen Eisenmangel, Nephrologie und kardiorenale Therapien zu werden. Das Unternehmen ist der bevorzugte Partner für Pharmaprodukte und innovative, patientenorientierte Lösungen. Die Vifor Pharma Gruppe will Patienten mit schweren und chronischen Krankheiten auf der ganzen Welt dabei helfen, ein Leben in besserer Gesundheit zu führen. Das Unternehmen entwickelt, produziert und vermarktet pharmazeutische Produkte für eine optimale Patientenversorgung. Die Vifor Pharma Gruppe nimmt in allen ihren Kerngeschäften eine führende Position ein und besteht aus folgenden Unternehmen: Vifor Pharma, Vifor Fresenius Medical Care Renal Pharma (ein gemeinsam mit Fresenius Medical Care geführtes Unternehmen); und OM Pharma.

Die Vifor Pharma Gruppe hat ihren Hauptsitz in der Schweiz und ist an der Schweizer Börse (SIX Swiss Exchange, VIFN, ISIN: CH0364749348) kotiert.

Weitere Informationen finden Sie auf www.viforpharma.com/career

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