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Pharmacovigilance Compliance Leader

Pharmacovigilance Compliance Leader

GE HealthCareOslo, Oslo fylke, Norge
30+ days ago
Job description

Overview

Pharmacovigilance Compliance Leader at GE HealthCare – join to apply.

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, with 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.

Job 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.

Responsibilities

  • Maintain and continually improve a suite of lean PV operating procedures (SOPs) that can be consistently applied across the organization
  • Design and implement supporting PV training and awareness initiatives
  • Continuously monitor the effectiveness of the QMS through deviation management, audit outcomes, KPI reporting, management review, and authority inspection support to drive strategic improvement
  • SOP and Quality Document Management : Draft, review, and maintain standard operating procedures, 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 with cross-functional teams including Quality Assurance, Regulatory Affairs, Medical Affairs, and Local Safety Units to ensure consistent application of PV standards
  • Training and Awareness : Support development and delivery of PV training programs 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 relationships 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 in a multicultural environment
  • Ability to work with interdisciplinary, highly matrixed teams and to communicate complex messages; strong 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; time-sensitivity awareness
  • High integrity, flexibility, and willingness to travel 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.

    Total Rewards

    Our total rewards are designed to unlock your ambition by providing compensation and benefits commensurate with the role, with opportunities for career growth within a global organization.

    Additional Information

    Relocation Assistance Provided : No

    Seniority level

  • Mid-Senior level

    • Employment type

  • Full-time

    • Job function

  • Management and Manufacturing

    • Industries

  • Pharmaceutical Manufacturing
  • Biotechnology Research
  • Medical Equipment Manufacturing

    • #J-18808-Ljbffr

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    Pharmacovigilance Compliance Leader • Oslo, Oslo fylke, Norge