Pharmacovigilance Operations Manager

Amgen UK

Not specified
Understanding of global regulatory requirements for pharmacovigilance
Project leadership experience in safety systems
Experience supporting inspections or internal audits
Amgen UK is seeking a Pharmacovigilance Operations Manager to oversee safety reporting and vendor management in compliance with regulatory requirements. The ideal candidate will have leadership experience, a strong understanding of global pharmacovigilance regulations, and a background in safety systems

Job Summary

  • The primary responsibility is acting as the US/EU local safety office and FDA/EMA point of contact for safety reporting.
  • You will support the submission of all individual case safety reports to regulatory authorities, business partners, and vendors.
  • This role involves managing staff within Case Management and ensuring compliance with approved processes and training requirements.

Matching Summary

Match Score: 85

Amgen UK is seeking a Pharmacovigilance Operations Manager to oversee safety reporting and vendor management in compliance with regulatory requirements. The ideal candidate will have leadership experience, a strong understanding of global pharmacovigilance regulations, and a background in safety systems.

Skills & Requirements

Must-have

  • Understanding of global regulatory requirements for pharmacovigilance
  • Project leadership experience in safety systems
  • Experience supporting inspections or internal audits
  • Competence in safety systems and Microsoft Suite

Nice-to-have

  • Dynamic team collaboration skills
  • Innovative approach to success
  • Strong vendor management capabilities

Key Requirements

  • Master's degree and 3 years directly related experience
  • Bachelor's degree and 5 years directly related experience
  • Previous experience directly managing teams or projects
  • Proficiency in Microsoft Word, Excel, PowerPoint, Project, Outlook

Work Rights

Not specified

Tailored Resume

Cover Letter