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Drug Safety Associate / Senior Drug Safety Associate

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About the role

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Company profile
 
For our mother company ICON, a global provider of outsourced development services, we are looking for two (Senior) Drug Safety Associate (m/f) for initially 6 months (temporary contract, extension possible) office based in one of our clients offices in UK or Germany.
 
 
Main tasks & responsibilities:
  • Review and process serious adverse events, spontaneously reported adverse reactions and/or other medically related information per assigned tasks and study specific procedures
  • Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files
  • Perform safety review of clinical and diagnostic data
  • Liaise with investigational site, reporter, and/or Sponsor as necessary regarding safety issues
  • Serve as resource for investigational sites and ICON personnel on safety-related issues
  • Liaise with Sponsor and attend Sponsor meetings, as required
  • Liaise with ICON project manager, and other departments, as appropriate
  • Assist management with weekly and monthly project status reports
 
 
 
Education, skills & experience
·         Relevant clinical research / pharmaceutical industry experience in pharmacovigilance / drug safety.
·         Thorough knowledge of regional safety processes and regulations
·         Good database skills (Argus)
·         Knowledge of medical terminology and coding systems
·         Good communication skills and Ability to work independently
·         Work effectively within a team environment
·         Fluent in written and verbal English
 
 
List #1

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