Job Description Summary

We are seeking a highly motivated and detail-oriented PV Compliance Leader to strengthen our global Pharmacovigilance Quality Team (PV-QA).

The PV Compliance Leader plays a critical role in ensuring the integrity and compliance of the Global Pharmacovigilance (PV) system. This role supports the development and maintenance of PV quality documentation drives audit and inspection readiness and leads the resolution of compliance findings. The ideal candidate is passionate about driving compliance and continuous improvement and has a strong understanding of Good Vigilance Practices a proactive mindset and the ability to collaborate across global functions.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition turn ideas into world-changing realities and join an organization where every voice makes a difference and every difference builds a healthier world

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 experiencein Pharmacovigilance Quality or Regulatory activities within thePharma/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 inEnglish(written and spoken); proficiency in other languages is an asset

• Proficient inMicrosoft Office withstrong Excel skills

Desired Skills

• Self-motivated with the ability toprioritize schedule and organizedaily 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 toset priorities and pivotas needed in a dynamic environment ability to recognize time sensitivity

• High integrity flexibility and willingness totravel occasionally

Inclusion and Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race color religion national or ethnic origin sex sexual orientation gender identity or expression age disability protected veteran status or other characteristics protected by law.

Behaviors

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus and drive ownership always with unyielding integrity.

Total Rewards

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything youd expect from an organization with global strength and scale and youll be surrounded by career opportunities in a culture that fosters care collaboration and support.

#LI-MG1

Additional Information