Clinical Safety Senior Specialist
PharmaLex
Lisbon, Portugal
há 2 dias

Your Job

  • Provide support to CSL and act as their back-up during holidays.
  • Oversight of activities performed by Junior specialists Training safety specialists / Overview of SAE process handled by junior specialists.
  • Support Safety Manager with Review of cases in safety database (QC)

  • DSUR support with some sections and DSUR submission
  • SUSAR management SUSAR submissionMaintaining SUSAR trackers for every projectMaintaining LL trackers for every project
  • Maintaining annual plans for LLs / DSURs and distribution lists.
  • Monthly updates on local requirements from Regulatory Authorities / Ethic Committees
  • Your Profile

  • Successful completion of a Bachelor’s degree in medical, natural sciences or pharmacy-related field or Degree in Medicine
  • Good knowledge of clinical trial PV legislation (at least in EU) and in Good Clinical Practices
  • At least 1 year of relevant professional experience in the field of Pharmacovigilance. Knowledge of safety databases (Argus, Safety Easy are preferred)Experience in case management activitiesPrevious experience in pre-authorisation area.
  • Team-oriented approach
  • Organizational skills, ability to multi-task. Ability to assimilate and analyse information rapidly.
  • High sense of responsibility and self-motivation
  • Highly service-oriented
  • Flexibility and adaptability to adjust rapidly to new, unknown, challenging situations.
  • Fluent written and spoken English skills.
  • Excellent written and verbal communication skills.
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