Drug Safety Coordinator

Connexion Systems & Engineering, Inc.; North Carolina; On-site; USD 52,000 - 76,000; Full time

Job summary

Connexion Systems & Engineering, Inc. seeks a Drug Safety Coordinator to support pharmacovigilance tasks in a clinical research setting.

The ideal candidate will work independently, manage adverse event information, and ensure compliance with GCP and SOPs, with experience in ARGUS or similar databases. Strong organizational and communication skills are essential for collaboration with cross-functional teams.

Qualifications

• Associate degree required.
• 2–3 years of recent clinical experience.
• Clinical drug development experience preferred.
• Experience with ARGUS or a similar safety database preferred.
• Strong knowledge of medical terminology.
• Ability to multitask and work independently in a regulated environment.

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 report type (initial, follow-up, or duplicate).
• Create and maintain case folders and related documentation.
• Review source documents and redact 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 is necessary.
• Maintain understanding of clinical study protocols and GCP guidelines.
• Manage the receipt, review, and filing of literature sources with AE information.
• Collaborate with Drug Safety Scientists, management, and cross-functional teams.

Skills

Attention to detail

Organizational skills

Multitasking

Communication skills

Interpersonal skills

Prioritization

Regulatory compliance

Education

Associate degree

Tools

ARGUS

Job description

Job Description

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 aDrug 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 withARGUS or other safety databasesis preferred.
In this role, you will obtain, review, process, and maintain information related to adverse events while ensuring compliance withGood 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.