job title: Pharmacovigilance compliance leader (GE Healthcare)

Roles and Responsibilities

Job Description

Description

The PV/QA team serves as a strategic bridge between the Quality Assurance (QA) and Global Pharmacovigilance (PV) organizations, fostering a culture of compliance and continuous improvement. PV-QA are accountable for ensuring PV compliance with regulatory obligations and the GEHC PDx Quality Management System across the global PV network, through the following activities:

• Maintain and continually improve a suite of lean PV operating procedures that can be consistently applied across the organisation

• Design and implement supporting PV training and awareness initiatives

• Continuous monitoring of the effectiveness of the QMS through deviation management, audit outcome, KPI reporting, management review, and authority inspection support to drive strategic improvement

Responsibilities

SOP and Quality Document Management: Draft, review, and maintain standard operating procedures (SOPs), work instructions, and related PV quality documentation to ensure alignment with regulatory requirements and internal QMS standards.

Audit and Inspection Support: Prepare for internal and external audits and regulatory inspections by coordinating documentation, training, and readiness activities. Act as a point of contact during inspections and support follow-up actions.

CAPA and Deviation Management: Lead or support root cause investigations for audit findings, deviations, and non-compliance issues. Develop and implement corrective and preventive action (CAPA) plans and track their effectiveness.

Compliance Monitoring: Monitor compliance metrics and KPIs across the PV system. Identify trends and areas for improvement and contribute to continuous quality improvement initiatives.

Stakeholder Collaboration: Work closely with cross-functional teams including Quality Assurance, Regulatory Affairs, Medical Affairs, and Local Safety Units to ensure consistent application of PV standards and practices.

Training and Awareness: Support the development and delivery of PV training programs and awareness initiatives across the Global PV Network and PDx organization.

• Qualifications

  • Academic degree in life sciences; pharmacy or nursing preferred

  • Significant experience in Pharmacovigilance, Quality, or Regulatory activities within the Pharma/Life Sciences industry

  • Strong knowledge of GvP and global PV regulatory requirements

  • Proven experience in SOP writing, audit/inspection preparation, and CAPA management

  • Working knowledge of Safety and Deviation management databases

  • Exposure to working relationship with FDA, EMA and other regulatory authorities is an asset

  • Fluent in English (written and spoken); proficiency in other languages is an asset

  • Proficient in Microsoft Office, with strong Excel skills

  Desired Skills

  • Self-motivated with the ability to prioritize, schedule, and organize daily activities

  • Excellent communication and interpersonal skills: ability to communicate across organization levels and to connect with different audiences in a multicultural environment

  • Ability to work with interdisciplinary, highly matrixed teams and able to communicate complex messages. Good negotiating and influencing skills

  • Strong commitment to compliance with relevant regulations and procedures

  • Ability to set priorities and pivot as needed in a dynamic environment, ability to recognize time sensitivity

  • High integrity, flexibility, and willingness to travel occasionally