Drug Safety Coordinator

Location: Clayton, NC 27520
Pay: $23 - $26/hr, paid weekly
Schedule: Monday–Friday, 8:30 AM–5:00 PM

Overview

The Drug Safety Coordinator supports the Global Pharmacovigilance team by reviewing, tracking, and processing potential adverse event (AE) information from clinical and scientific sources. This role serves as an initial point of review for incoming safety documentation and helps ensure adverse event information is complete, accurate, properly documented, and processed within required timelines.

The ideal candidate has recent clinical or drug development experience, strong knowledge of medical terminology, excellent attention to detail, and the ability to manage confidential information in accordance with Good Clinical Practices (GCP), regulatory requirements, and company procedures.

Key Responsibilities

• Review incoming clinical documentation and scientific literature to identify potential adverse event (AE) information.
• Perform initial reviews of source documents to determine completeness and identify whether additional follow-up is required.
• Enter adverse event reports into tracking systems and classify them as initial, follow-up, or duplicate reports.
• Create and maintain accurate case folders and supporting documentation.
• Redact confidential patient information from source documents to maintain privacy and regulatory compliance.
• Record protocol numbers, site information, and patient identifiers on appropriate safety documentation.
• Route completed documentation to assigned case owners for further review and processing.
• Receive, review, log, and file scientific literature that may contain adverse event information.
• Maintain knowledge of assigned study protocols, clinical trial requirements, and applicable scopes of work.
• Follow Good Clinical Practices (GCP), regulatory reporting requirements, and company SOPs.
• Support Drug Safety Scientists and management with safety-related projects and departmental activities.
• Collaborate effectively with team members and cross-functional departments to support timely and accurate case management.

Qualifications

• 2–3 years of recent experience in a clinical setting, clinical drug development, or a related environment.
• Knowledge of medical terminology and the ability to understand and interpret scientific and clinical information.
• Strong organizational, prioritization, and multitasking skills.
• Excellent attention to detail and documentation accuracy.
• Strong computer skills and ability to work with electronic tracking systems and databases.
• Effective written and verbal communication skills.
• Ability to work independently with minimal supervision while meeting established deadlines.
• Experience with pharmacovigilance or safety databases, such as Argus, is preferred.

Education

• Associate degree required.

Benefits: Employee contribution and may include:

• Health insurance.
• Health savings account.
• Dental insurance.
• Vision insurance.
• Flexible spending accounts.
• Life insurance.
• Retirement plan.

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Rate of pay within the stated range will depend on the qualifications of the applicant.