Aufgaben

  • Responsible for complete case processing: triaging, data entry, coding of AEs, narrative writing, quality control and submission of expediting AE reports to health authorities
  • Perform case prioritization according to relevant Standard Operating Procedures to ensure timely submission of expediting reports to regulatory authorities
  • Identification of missing information and initiation of follow up requests in collaboration with Drug Safety Physician
  • Daily monitoring of the workflow and work lists to ensure all cases are prioritized and processed as appropriate
  • Performs or oversees reconciliation activities

Qualifikationen

  • University degree in life sciences (pharmacy, nurse) or equivalent education in health-related field
  • At least 5 years' experience in safety
  • Knowledge of medical terminology and general understanding of disease processes
  • Solid knowledge of coding thesauri and medical/drug dictionaries
  • Good knowledge of the EU and US safety reporting requirements
  • Excellent organizational and problem-solving skills, interpersonal skills, and the ability to work under pressure and meet short timelines
  • Fluency in English, both verbal and written