Safety & Pv Specialist I - Based In Sofia Area

Syneos Health

Sofia, , Bulgaria
Icsr case processing
Meddra coding
Safety database systems knowledge
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success and improve patient outcomes

Job Summary

  • Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success and improve patient outcomes.
  • The role involves assisting with all aspects of safety and pharmacovigilance activities including case processing, literature review, coding, data validation, and regulatory reporting.
  • The company is committed to career development, diversity, inclusion, and fostering a culture where employees can authentically be themselves.

Matching Summary

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success and improve patient outcomes.

Skills & Requirements

Must-have

  • ICSR case processing
  • MedDRA coding
  • Safety database systems knowledge
  • Clinical trial safety requirements
  • Data management and validation
  • Good Pharmacovigilance Practice (GVP)

Nice-to-have

  • Advanced MedDRA coding training
  • Signal detection management experience
  • Excellent communication skills
  • Ability to work independently and in teams
  • Good organizational and prioritization skills

Key Requirements

  • Bachelor’s Degree in life science or equivalent
  • 4+ years experience in ICSR case processing
  • Knowledge of ICH GCP and global pharmacovigilance regulations
  • Proficiency in Microsoft Office and related software
  • Good English language skills
  • Minimal travel up to 5%

Work Rights

Not specified

Tailored Resume

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