Drug Safety Coordinator

Job Description

Job Description

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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Why TalentBurst?
At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.

Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.

We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.

\nCompany Description

Founded in 2002 by three former Monster.com executives; TalentBurst is an award-winning full-service Staffing Firm working directly with Fortune 500 companies in the US and Canada. We specialize in Contract and Contract to Permanent roles across many industries and have direct/contractual relationships with all our clients. Please visit our website or come meet us at our offices in Natick, MA, Miami, FL, Christiansburg, VA, Vineland, NJ, Houston, TX & downtown San Francisco, CA

Company Description

Founded in 2002 by three former Monster.com executives; TalentBurst is an award-winning full-service Staffing Firm working directly with Fortune 500 companies in the US and Canada. We specialize in Contract and Contract to Permanent roles across many industries and have direct/contractual relationships with all our clients. Please visit our website or come meet us at our offices in Natick, MA, Miami, FL, Christiansburg, VA, Vineland, NJ, Houston, TX & downtown San Francisco, CA