Drug Safety Coordinator

Title:
Drug Safety Coordinator

Location:

Clayton, NC
Duration: 12+ Months

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.
a. Responsible for monitoring all incoming information and identification of potential AE information and assembling data for team meetings.
b. 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.
c. Identify and delete all confidential patient information from the source documents received.
d. Record protocol number and site/patient number, if applicable, on all source documents.
e. 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. Strong computer literacy required.

Requirements:

• Associate degree

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

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