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Archiviertes Projekt - Senior Clinical Safety Officer (m/f/d)

Firmenname für PREMIUM-Mitglieder sichtbar

  • April 2021
  • nicht angegeben
  • CH-Vaud
  • auf Anfrage
  • 12.03.2021
  • 531054/1-en

Projektbeschreibung

Ihre Aufgaben:
•  Manages case processing for clinical trials and electronic reporting to Health Authorities
• Manages the interactions with internal departments as well as vendors, sponsors, commercial partners and CROs in the area of Clinical Safety
• Ensures reconciliation between the clinical and safety database
• Coordinates Development Safety Update Reports (DSURs)
• Writes Safety Management Plans
• Ensures Signal detection activities for products in development as a member of the Safety Assessment Committee
• Ensures the appropriate filing of clinical safety documents in the eTMF
• Implements CAPA changes to update the system and processes
• Creates and maintains local SOPs & Working Instructions
• Collaborates with license partners and ensures maintenance of Pharmacovigilance Agreements and workflow documents for products used in clinical trials with our products in development
• Participates in audits and inspections
• Manages CROs for relevant sub-contracted activities
• Back-up person for other clinical safety officers

Ihre Qualifikationen:
• Degree in Biology, Pharmacist
• Profound experience in clinical safety with good knowledge of EU and US regulations
• Experience in audit and/or inspection and implementation of CAPA changes
• Successful track record in managing external partners
• XEVMPD and Eudravigilance training certificates would be an asset 
• Strong experience with a Safety Database
• Solid writing and editorial skills, as well as familiarity with medical terminology
• Experience in Oncology drug development preferred
• Team player, used to work in a matrix organization
• Demonstrate excellent written and verbal communication skills in English and French 

Ihre Vorteile:
• Dynamic enterprise

Projektdauer: limited


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