Senior Drug Safety Associate

ICON Clinical Research, LP

Sofia, Bulgaria
**
Adverse event reporting and processing
Periodic safety update report preparation
Signal detection and data analysis
** ICON Clinical Research is seeking a Senior Drug Safety Associate in Sofia, Bulgaria, who will be responsible for managing pharmacovigilance activities and ensuring compliance with regulatory requirements. The role emphasizes collaboration, data analysis, and maintaining patient safety while offering a supportive and inclusive work environment. **

Job Summary

  • The role involves leading the collection, evaluation, and processing of adverse event reports to ensure timely and accurate regulatory compliance.
  • Candidates will collaborate with medical and clinical teams to assess clinical relevance and contribute to risk management activities.
  • ICON offers a competitive salary along with comprehensive benefits including health insurance, retirement planning, and global employee assistance programs.

Matching Summary

Match Score: 75

** ICON Clinical Research is seeking a Senior Drug Safety Associate in Sofia, Bulgaria, who will be responsible for managing pharmacovigilance activities and ensuring compliance with regulatory requirements. The role emphasizes collaboration, data analysis, and maintaining patient safety while offering a supportive and inclusive work environment. **

Skills & Requirements

Must-have

  • Adverse event reporting and processing
  • Periodic safety update report preparation
  • Signal detection and data analysis
  • Regulatory compliance in pharmacovigilance
  • Pharmacovigilance database management

Nice-to-have

  • Mentorship of junior team members
  • Cross-functional collaboration skills
  • Audit and inspection readiness
  • Advanced degree in life sciences
  • Continuous improvement of processes

Key Requirements

  • Bachelor's degree in life sciences or pharmacy
  • Extensive experience in pharmacovigilance
  • Proficiency in pharmacovigilance databases
  • Strong analytical and critical thinking skills

Work Rights

Not specified

Tailored Resume

Cover Letter