Gps Risk Management Specialist

BAXTER HEALTHCARE PTY AUS

San Gwann, Malta
Base: €36,800.00 annually; bonus/equity: discretio...
Pharmacovigilance risk management plans
Authoring pv-rmps
Eu regulations
This position is part of the Risk Management function within the GPS organization, responsible for development and management of Pharmacovigilance Risk Management Plans (PV-RMPs) to support Baxter’s drug and biologic products

Job Summary

  • This position is part of the Risk Management function within the GPS organization, responsible for development and management of Pharmacovigilance Risk Management Plans (PV-RMPs) to support Baxter’s drug and biologic products.
  • Serve as primary author for PV-RMPs, utilizing various regional/local/company templates and ensuring compliance to regional/local regulatory requirements.
  • At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life.

Matching Summary

This position is part of the Risk Management function within the GPS organization, responsible for development and management of Pharmacovigilance Risk Management Plans (PV-RMPs) to support Baxter’s drug and biologic products.

Salary

Base: €36,800.00 annually; Bonus/Equity: discretionary bonuses and/or long-term incentive; Benefits: competitive benefits

Skills & Requirements

Must-have

  • Pharmacovigilance Risk Management Plans
  • authoring PV-RMPs
  • EU regulations
  • cross-functional review and approval
  • respond to regulatory authority queries

Nice-to-have

  • scientific/clinical knowledge
  • interpersonal skills
  • collaboration with country organizations
  • training new team members

Key Requirements

  • Minimum two years’ prior pharmaceutical industry experience
  • Minimum two to three years’ general experience authoring PV-RMPs
  • Prior experience authoring EU RMPs is required
  • Bachelor’s degree in nursing/biologic/medical/clinical field

Work Rights

Not specified

Tailored Resume

Cover Letter