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
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.
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.
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.
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Additional Information
Relocation Assistance Provided: No
