Regulatory Review Advisor, Patient Safety

medizinstellenmarkt.de

Regulatory reporting compliance
Adverse event and safety reporting
Pharmacovigilance reporting activities
Ensure timely and accurate submission of Adverse Event Reports, Periodic Safety Update Reports, and other required documentation

Job Summary

  • Ensure timely and accurate submission of Adverse Event Reports, Periodic Safety Update Reports, and other required documentation.
  • Provide training and guidance to GBS internal teams on regulatory reporting obligations and best practices.
  • Your expertise powers an enterprise driven by science and purpose, where every accurate report and informed decision can help bring therapies to patients faster.

Matching Summary

Ensure timely and accurate submission of Adverse Event Reports, Periodic Safety Update Reports, and other required documentation.

Skills & Requirements

Must-have

  • Regulatory reporting compliance
  • Adverse Event and Safety Reporting
  • Pharmacovigilance reporting activities
  • Global regulatory reporting requirements
  • Maintain documentation for audits

Nice-to-have

  • Process improvement attitude
  • Tight-knit collaboration skills
  • Curiosity and honest feedback
  • Kindness alongside ambition

Key Requirements

  • Experience with safety databases and regulatory systems
  • Familiarity with MedDRA and WHODrug coding
  • Track record of leading or supporting audits

Work Rights

Not specified

Tailored Resume

Cover Letter