Pharmacovigilance Compliance Leader at GE Healthcare

Oslo, Oslo, Norway

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Technology, PharmaceuticalsIndustries

Requirements

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
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

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
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

Skills

Pharmacovigilance

Good Vigilance Practices

SOP Management

Quality Assurance

Audit Readiness

Inspection Support

Deviation Management

KPI Reporting

QMS

Training Initiatives

GE Healthcare

Healthcare technology and data analytics provider

About GE Healthcare

GE Healthcare provides a range of healthcare technologies and services aimed at improving patient care. Its main products include imaging systems, mobile diagnostic devices, patient monitoring solutions, and advanced software for data analysis. These products help medical professionals make informed decisions and enhance the efficiency of healthcare delivery. Unlike many competitors, GE Healthcare invests significantly in research and development, allocating $1 billion each year to innovate and enhance its offerings. The company’s goal is to support healthcare providers in delivering better patient outcomes, as evidenced by its technology supporting over 300,000 patients daily and managing 2 billion patient scans each year.

Chicago, IllinoisHeadquarters

1892Year Founded

N/ACompany Stage

Data & Analytics, HealthcareIndustries

10,001+Employees

Risks

Emerging AR technologies increase competition in medical imaging.

Regulatory challenges may delay AI application expansions in healthcare.

Dependence on clinical trial success for new product market positioning.

Differentiation

GE Healthcare invests $1 billion annually in R&D for product innovation.

The company supports over 300,000 patients daily with its healthcare technologies.

GE Healthcare's AIR Recon DL offers 3D motion-insensitive imaging for enhanced MRI quality.

Upsides

Acquisition of Caption Health expands AI-powered ultrasound capabilities.

Successful Phase III trial of [18F]flurpiridaz enhances coronary artery disease detection.

Collaboration with Wayra accelerates digital health innovation in EMEA.

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