Pharmacovigilance Operations Manager

Amgen Australia Pty Ltd

Not specified
Understanding of global regulatory requirements for pharmacovigilance
Project leadership experience in safety systems
Experience supporting inspections or internal audits
Amgen Australia Pty Ltd is seeking a Pharmacovigilance Operations Manager to oversee safety reporting and vendor management in compliance with regulatory standards. The role emphasizes project leadership, team management, and quality assurance within pharmacovigilance operations

Job Summary

  • The primary responsibility is acting as the US/EU local safety office and FDA/EMA point of contact for safety reporting.
  • The role involves vendor oversight, ensuring compliance with approved processes, and managing case intake processing activities.
  • Candidates must support regulatory inspections and maintain a state of inspection readiness within the remit of their responsibilities.

Matching Summary

Match Score: 85

Amgen Australia Pty Ltd is seeking a Pharmacovigilance Operations Manager to oversee safety reporting and vendor management in compliance with regulatory standards. The role emphasizes project leadership, team management, and quality assurance within pharmacovigilance operations.

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 environment dedicated to patient care
  • Innovative approaches to success
  • Cohesive team culture

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
  • Experience with ICSR processing and regulatory submissions

Work Rights

Not specified

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