Drug Safety Scientist, Global Pharmacovigilance

Job Description Summary

Join our dynamic Drug Safety & Risk Management team at GE Healthcare, where we are dedicated to ensuring the safety of our products and the well-being of patients worldwide.

As a Drug Safety (DS) Scientist, you will play a crucial role in performing pharmacovigilance tasks and preparing regulatory documents with precision and compliance. Your work will support both clinical trials and post-marketing activities.

Job Description

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.

Key Responsibilities

• Pharmacovigilance and Regulatory Compliance: Perform safety monitoring tasks and prepare submission-ready documents in line with global and local regulations.
• Scientific Support: Assist the Medical Director with safety activities from clinical trials and post-marketing experience.
• Inspection Readiness: Support the EU Qualified Person for Pharmacovigilance (QPPV) in preparing for inspections.
• Daily Operations: Engage in planning, meetings, database searches, safety analysis, case reviews, writing, and project management.
• Collaboration: Work closely with team members, Medical Directors, QPPV, and vendors to ensure seamless operations.
  
  

Roles And Responsibilities

• Manage core safety deliverables, including scheduled and ad hoc aggregate reports.
• Produce high-quality safety evaluation documents with clear conclusions for internal and regulatory requests.
• Run accurate queries and provide standard outputs from the safety database.
• Support the preparation of Risk Management Plans (RMP) and post-marketing safety monitoring.
• Review global medical/scientific literature to identify safety signals.
• Conduct routine and ad-hoc signal detection and evaluate safety data.
• Compile safety information for reference safety information, including Company Core Safety Information.
• Participate in Safety Management Team meetings.
• Support drug safety physicians with clinical and post-marketing safety issues.
• Lead projects to improve processes and efficiency using Lean strategies.
• Serve as a Pharmacovigilance Subject Matter Expert (SME) during audits and inspections.
  
  

Required Qualifications

• Bachelor’s or master’s degree in biological or natural sciences, or a healthcare discipline.
• Minimum of 2 years of experience in the pharmaceutical/biotechnology industry, including clinical trial and post-marketing pharmacovigilance.
• Global experience is preferred.
• Proficiency in summarizing and evaluating data, with experience in safety databases.
• Strong report writing skills (e.g., aggregate reports, regulatory responses).
• Knowledge of FDA, EU, and ICH guidelines and regulations governing pharmacovigilance.
  
  

Desired Characteristics

• Ability to thrive in a fast-paced environment with rapidly changing priorities.
• Strong project management skills, with the ability to manage multiple projects simultaneously.
• High level of accuracy, attention to detail, and quality in all tasks.
• Independent and proactive, with a strong initiative.
  
  

Why Join Us

• Professional Growth: Opportunities for continuous learning and career advancement.
• Impactful Work: Contribute to the safety and well-being of patients globally.
  
  

Apply Now: If you are passionate about drug safety and eager to make a difference, we encourage you to apply. Join us in our mission to improve healthcare outcomes for all.

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.

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

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 age, disability, protected veteran status or other characteristics protected by law.

Additional Information

Relocation Assistance Provided: No