51 days ago on vifor.avature.net


Vifor Pharma AG

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Ihr Profil
We are currently looking for a Drug Safety Associate who will ensure the coordination of all safety data processing and be based in our headquarters in Glattbrugg/Zurich. Reporting directly to the Head of Drug Safety Case Management, you will be responsible for the efficient and consistent processing of all adverse event reports from different sources (spontaneous, clinical trial, literature and others) as measured by metrics and KPI’s. Your responsibilities will also include:
  • Ensure appropriate tracking of inbound and outbound communication related to individual safety cases
  • Ensure consistency in case classification, causality, labelling, MedDRA, WHO-Drug coding, narratives
  • Liaise with other Drug Safety Associates regarding their case processing tasks (medical evaluation, QC)
  • Ensure safety reporting in clinical are handled appropriately and reporting is in compliance with regulations to Health Authorities, Ethical committees and
  • External Safety Review Boards
  • Coordinate case follow-up activities and reconciliation with Health Authorities / Contractual Partners/ CRO’s
  • Check screen results for case inclusion and safety relevance for literature cases
  • Liaise with affiliates and partners for expedited compliance and with the Drug Safety Associates (Data Management, DS Systems) in all aspects of E2B reporting; database and application management, data retrieval and custom reporting
  • Ensure Standard Operating Procedures for drug safety are up to date and in line with applicable regulations; processes are in compliance with SOPs
  • Liaise with Quality Assurance in handling Product Technical Complaints associated with adverse events or received initially by Global Drug Safety
  • Ensure all safety data can be presented in a timely and appropriate manner for benefit-risk assessment and aggregate reporting
  • Manage expedited reporting and ensuring compliance for both spontaneous and clinical reports

For this role, we are looking for a strongly detail oriented candidate with high tolerance to time and work pressure. In addition, you will bring the following profile:

  • University degree in pharmacology, medicine, healthcare or other life sciences
  • Minimum 3 years of experience in post marketing surveillance/drug safety operations including: case classification, causality, labelling, MedDRA, WHO-
  • Drug coding and narratives
  • Excellent user of MS Office tools (Word, Excel, PowerPoint, Outlook)
  • Experience in drug safety database (ARISg) and/or MS SharePoint is an asset
  • Fluency in English, both in oral and written communication; knowledge of French or German language would be an asset
  • Excellent communication and analytical skills

We are looking for a good team player with effective cross-functional working skills and the ability to develop good working relationships with services providers and worldwide partners. Furthermore, you demonstrate a good sense of organization and prioritization and abilities to identify critical situations from a drug safety point of view. Finally, your good life science, pharmaceutical and medical knowledge as well as your substantial knowledge in drug safety will allow you to be successful in this position and in line with Vifor Pharma values.

Über uns

Vifor Pharma, ein Unternehmen der Galenica Gruppe, ist eine der weltweit führenden Gesellschaften im Bereich Erforschung, Entwicklung, Herstellung und Vermarktung von pharmazeutischen Produkten zur Behandlung von Eisenmangel. Das Unternehmen bietet zudem mit den spezialisierten Abteilungen in den Bereichen Infektionskrankheiten/OTX und Consumer Healthcare ein diversifiziertes Portfolio an verschreibungspflichtigen Medikamenten und nicht verschreibungspflichtigen (OTC) Produkten an. Vifor Pharma mit Sitz in Zürich, Schweiz, baut seine globale Präsenz laufend aus und verfügt über ein umfassendes Netzwerk aus Tochtergesellschaften und Partnern weltweit.

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