Drug Safety Associate - Zurich

Lieu: Switzerland - Glattbrugg/Zurich

Fonction: Drug Safety/Pharmacovigilance

Niveau de Séniorité: Specialist

Votre 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

A propos de nous

Le groupe Vifor Pharma est une entreprise pharmaceutique internationale spécialisée. Son ambition est de devenir le leader mondial dans les domaines de la carence en fer, de la néphrologie et des traitements cardio-rénaux. L’entreprise est le partenaire de choix pour les médicaments et les solutions innovantes axées sur le patient. Le groupe Vifor Pharma aspire à aider les patients du monde entier atteints de maladies graves et chroniques à mener une vie meilleure et plus saine. La société développe, fabrique et commercialise des produits pharmaceutiques offrant des soins de précision aux patients. Le groupe Vifor Pharma occupe une position de premier plan dans toutes ses activités clés. Il se compose des entreprises suivantes: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma (sa société commune avec Fresenius Medical Care); et OM Pharma.

Le groupe Vifor Pharma a son siège en Suisse et est coté à la Bourse suisse (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).

Pour de plus amples informations, veuillez consulter www.viforpharma.com/career

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