Pharmacovigilance 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

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.