Pharmacovigilance Compliance Coordinator

Pharmacovigilance Compliance Coordinator

Job Description Summary: We are seeking a detail-oriented and proactive Pharmacovigilance Coordinator to support the operational and compliance activities of our Pharmacovigilance Quality Team (PV-QA).

This entry-level position offers a great foundation for individuals seeking to build a career in the pharmaceutical or life sciences industry, particularly in the areas of drug safety, quality assurance, and regulatory compliance. As part of a global team, the coordinator will gain hands-on experience with pharmacovigilance systems and global PV operations and will have access to a structured environment to develop core competencies in Good Vigilance Practices (GvP) and Quality Management Systems.

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.

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 is 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 outcomes, KPI reporting, management reviews, and authority inspection support to drive strategic improvement.
  

The PV Compliance coordinator will play a key role in maintaining documentation, ensuring data integrity, and supporting cross-functional collaboration.

Responsibilities

• PV Network Support: Assist in the onboarding and offboarding of PV Local Safety Units (LSUs). Maintain accurate and up-to-date records of contact details, regulatory requirements, and training documentation in the PV network database.
  
• Data Reconciliation: Perform regular reconciliation of safety information tracking logs to ensure timely and compliant submissions to the Central Safety Unit (CSU) and regulatory authorities.
  
• Cross-Functional Coordination: Collaborate with stakeholders across departments (e.g., Commercial, Medical Affairs) to reconcile data related to product complaints, medical inquiries, and other safety-relevant communications.
  
• Mailbox Management: Monitor and triage the team's shared mailbox. Respond independently to routine queries and escalate complex issues to appropriate team members.
  
• Third-Party Compliance: Support adherence to PV obligations outlined in agreements with distributors, contractors, and collaborative partners.
  
• Compliance Monitoring: Identify instances of noncompliance and contribute to investigations and implementation of corrective and preventive action plans (CAPAs).
  
• Audit and Inspection Readiness: Provide administrative and logistical support during internal audits and external regulatory inspections.
  

The PV Compliance coordinator will play a key role in maintaining documentation, ensuring data integrity, and supporting cross-functional collaboration.

Qualifications

• Academic degree in sciences; pharmacy or nursing preferred
  
• Some experience in Pharmacovigilance, Quality, or Regulatory activities within the Pharma/Life Sciences industry
  
• 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 skills: ability to communicate across organization levels and to connect with different audiences in a multicultural environment
  
• Ability to set priorities and pivot as needed in a dynamic environment
  
• Demonstrates reliability, 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.

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 you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

Additional Information

Relocation Assistance Provided: No

Seniority level

• Entry level
  

Employment type

• Full-time
  

Job function

• Legal
  

Industries

• Pharmaceutical Manufacturing
  
• Biotechnology Research
  
• Medical Equipment Manufacturing
  

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