Drug Safety Scientist, Global Pharmacovigilance

at  GE Healthcare

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.

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.

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.