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Gps Risk Management Specialist

Malta, San Ġwann Employment contract 36800.00 EUR / Year · Job Posted June 03, 2026
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Job Description

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 Responsibility

  • Serve as primary author for PV-RMPs, utilizing various regional/local/company templates and ensuring compliance to regional/local regulatory requirements
  • Facilitate cross-functional review and approval of PV-RMPs
  • Respond to queries/requests from regulatory authorities regarding PV-RMPs
  • Independently manage project timelines associated with preparation and submission of PV-RMPs
  • Represent GPS Risk Management on cross-functional teams
  • Collaborate with country organizations in developing and managing PV-RMPs and associated commitment activities
  • Support training of new GPS Risk Management team members

Requirements

  • Knowledge of worldwide PV-RMP regulations: prior experience with European Union (EU) regulations is required. Prior experience with other regional/local regulations is desired
  • Prior experience with the implementation of additional risk minimization measures is desired
  • Excellent analytical and critical thinking skills
  • Excellent oral, written, and interpersonal skills, including ability and comfort in leading cross-functional group discussions and meetings
  • Scientific/clinical knowledge and excellent scientific writing skills
  • Ability to independently manage long- and short-term project timelines and deliverables
  • Experience in responding to queries/requests from regulatory authorities
  • Bachelor’s degree in nursing/biologic/medical/clinical field
  • advanced degree and prior clinical practice experience is desired
  • Minimum two years’ prior pharmaceutical industry experience in Pharmacovigilance or Medical/Clinical functions
  • Minimum two to three years’ general experience authoring PV-RMPs. Prior experience authoring EU RMPs is required
  • experience with generic PV-RMP submissions within the EU is desired. Prior experience authoring PV-RMPs in non-EU regions is desired

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