Safety & Pv Specialist I

SyneosHealth

Safety database systems proficiency
Medical terminology knowledge
Meddra coding expertise
The role involves entering information into PVG quality systems and triaging ICSRs for regulatory reportability

Job Summary

  • The role involves entering information into PVG quality systems and triaging ICSRs for regulatory reportability.
  • Syneos Health is committed to a Total Self culture where employees can authentically be themselves while collaborating globally.
  • Candidates must maintain compliance with global drug regulations, SOPs, and ensure accurate submission of safety tracking documents.

Matching Summary

The role involves entering information into PVG quality systems and triaging ICSRs for regulatory reportability.

Skills & Requirements

Must-have

  • Safety database systems proficiency
  • Medical terminology knowledge
  • MedDRA coding expertise
  • ICSR processing and triage
  • ICH GCP and GVP regulations
  • Clinical trial process understanding

Nice-to-have

  • Strong organizational skills
  • Ability to work independently
  • Team collaboration mindset
  • Excellent written communication
  • Detail-oriented approach

Key Requirements

  • Bachelor's Degree in life science or nursing
  • Registered nurse or pharmacist qualification
  • Proficiency in Microsoft Office Suite and Visio

Work Rights

Not specified

Tailored Resume

Cover Letter