Senior Safety Coder

Role Summary

As part of the Global Coding Team (GCT), ensures accurate and consistent coding of medical data, including adverse event and medication data from global clinical trials across all therapeutic areas.

Responsibilities

• Primary coding resource for assigned studies and serves as subject matter expert to study team members and other key stakeholders.
• Ability to accurately code clinical trial data using MedDRA and WHODrug in accordance with company conventions.
• Ability to effectively perform all Clinical Coding Team workflow requirements through the life of the trial.
• Ability to support the identification of prohibited medications and/or other related exclusionary data.
• Ability to contribute to the development of and timely achievement of projects and goals.
• Represents Clinical Coding Team when collaborating with study team members and/or other key stakeholders.
• Participates in the development and/or maintenance of coding conventions, Standard Operating Procedures, Guidelines and/or Work Instruction documents.
• Participate in the completion of dictionary upversioning workflow activities.
• Supports departmental and cross-functional business requirements.
• Serve as a mentor and coach to new and/or less experienced coders.

Qualifications

• Preferred: 5+ years of Clinical Trial Coding Experience.
• Working knowledge medical and medication terminology.
• Working knowledge of MedDRA, and WHODrug.
• Working knowledge of Clinical trial data systems and/or EDC coding tools.
• Manage multiple tasks with competing priorities.
• Demonstrates effective problem-solving and communication skills.
• Ability to work independently as well as in a team environment.

Education

• Bachelor’s degree with related health science background (e.g., RN, BSN, RPh). Advanced Degree preferred.