Drug Safety Associate

Belcan; Clayton (NC); On-site; USD 26,000 - 36,000; Full time

Job summary

Belcan is seeking a Drug Safety Coordinator for a 12-month contract in Clayton, NC. The role focuses on independent completion of pharmacovigilance tasks with ARGUS/safety database experience preferred.

You will process adverse event data to ensure compliance with GCP, regulatory guidelines, and company SOPs, and support DSS and management in cross-functional collaboration. Primary responsibilities include AE information tracking, data entry, and case file creation, with a strong emphasis on

Qualifications

• 2-3 years of recent experience in a clinical setting or equivalent in experience or training.
• Clinical drug development experience preferred.
• Knowledge of GCP guidelines and regulatory reporting requirements.

Responsibilities

• Identify, track, and file potential adverse event (AE) information.
• Monitor incoming information and identify AE information; assemble data for team meetings.
• Enter the report into the tracking log and determine if it is initial, follow-up, or duplicate.
• Remove confidential patient information from source documents.
• Record protocol and site/patient numbers on documents.
• Provide the report to the conducting case owner.
• Review source documents for AE reports as first-point reviewer.
• Maintain protocol knowledge and adherence to SOPs.
• Manage literature sources that may contain AE information.

Skills

AE reporting

GCP knowledge

Medical terminology

Data entry

Multitasking

Interpersonal skills

Organizational skills

Tools

ARGUS safety database

Tracking log software

Job description

Duration: 12 Months Contract (Potential temp to perm)

Pay Rate: $19/hr. - $26/hr.

Shift Time: 1st shift, M-F (8:30 AM -5 PM)

Job Description:

The incumbent is required to be an independent contributor that efficiently and effectively accomplishes drug safety tasks and deliverables with little oversight. Prefer if they have ARGUS/safety database experience. As Global Drug Safety team member, DSC obtains and processes all appropriate information regarding adverse event data to maintain a thorough and strict adherence to Good Clinical Practices (GCP), regulatory guidelines, and company SOPs. Assists Drug Safety Scientist (DSS) and management in building team environment among assigned staff and between other departments.

Primary responsibilities

• Identify, track, and file potential adverse event (AE) information.
• Responsible for monitoring all incoming information and identification of potential AE information and assembling data for team meetings.
• Enter the report into the tracking log, check whether it is an initial, a follow-up, or a duplicate report and creates a case folder.
• Identify and delete all confidential patient information from the source documents received.
• Record protocol number and site/patient number, if applicable, on all source documents.
• Provide the report to the conducting case owner
• Identify, track, and file potential adverse event (AE) information.

Additional responsibilities

• The Drug Safety Coordinator is the first person in Global Pharmacovigilance to review the source documents for AE reports.
• As such, the DSC makes the first determination of report completeness and the need to perform follow-up with the reporter.
• Maintains a basic understanding of the protocol and scope of work for clinical studies.
• Maintains a thorough understanding and strict adherence to GCP guidelines and regulatory reporting regulations.
• Responsible for management of receipt, review and filing of literature sources that may contain AE information.

Knowledge, Skills, and Abilities

• Excellent technical skills required, including the ability to comprehend and integrate scientific data from a variety of sources.
• Comprehensive knowledge of medical terminology required.
• Excellent interpersonal, organizational, and prioritization skills.
• Flexibility and the ability to multitask is mandatory.

Requirements

• 2-3 years of recent experience in a clinical setting or equivalent in experience or training.
• Clinical drug development experience preferred.