Drug Safety Coordinator

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.

Drug Safety Coordinator

• Schedule: Monday – Friday, 8:30am – 5pm

Description:
We are seeking a Drug Safety Coordinator to support drug safety and pharmacovigilance activities within a clinical research environment. The ideal candidate will be an independent contributor who can efficiently manage drug safety tasks and deliverables with minimal oversight. Experience with ARGUS or other safety databases is preferred.

In this role, you will obtain, review, process, and maintain information related to adverse events while ensuring compliance with Good Clinical Practice (GCP), applicable regulatory requirements, and company standard operating procedures (SOPs).

Key Responsibilities

• Identify, track, and file potential adverse event (AE) information.
• Monitor incoming information and identify potential AE reports.
• Assemble relevant information for team meetings and case review.
• Enter reports into tracking systems and determine whether they are initial, follow-up, or duplicate reports.
• Create and maintain case folders and related documentation.
• Review source documents and remove confidential patient information as appropriate.
• Record protocol, site, and patient information on source documents when applicable.
• Provide reports and supporting documentation to the appropriate case owner.
• Review source documents for completeness and determine when follow-up with reporters may be necessary.
• Maintain a working understanding of clinical study protocols and scopes of work.
• Maintain strict adherence to GCP guidelines and regulatory reporting requirements.
• Manage the receipt, review, and filing of literature sources that may contain adverse event information.
• Collaborate effectively with Drug Safety Scientists, management, and cross-functional teams.

Qualifications

• Associate degree required.
• 2–3 years of recent experience in a clinical setting, or an equivalent combination of experience and training.
• Clinical drug development experience preferred.
• Experience with ARGUS or a similar safety database preferred.
• Strong knowledge of medical terminology.
• Ability to understand and integrate scientific information from multiple sources.
• Excellent organizational, interpersonal, and prioritization skills.
• Strong computer skills and technical proficiency.
• Ability to multitask, prioritize competing responsibilities, and work independently.
• Strong attention to detail and commitment to accuracy and regulatory compliance.

What You’ll Bring
The successful candidate will be detail-oriented, organized, adaptable, and comfortable working independently in a regulated clinical environment. This position requires strong communication skills, sound judgment, and the ability to manage sensitive information while maintaining a high level of accuracy.