Highlights
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. Knowledge, Skills, and Abilities: Excellent technical skills required, including the ability to comprehend and integrate scientific data from a variety of sources.
Numbers & Facts
| Location | Clayton, NC |
| Industry | Staffing/Employment Agencies |
| Salary | $19.23–$26 Per Hour |
| Company Size | 5,000 to 9,999 employees |
| Year Founded | 2002 |
| Website | http://www.talentburst.com/ |
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.
#TB_PH
#ZRHC
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.
#TB_PH
#ZRHC
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.
About Company
For over 20 years, TalentBurst Inc. has been an award-winning provider of cutting-edge Workforce Management Solutions. With a strong commitment to staying ahead in the tech landscape, we pioneer innovative approaches to talent acquisition. Our expertise spans Life Sciences, and Healthcare Staffing, Banking, Financial, IT, and Engineering, as well as Global Employer of Record (EOR), Agent of Record (AOR), State, Local Government and Education (SLED), and IC validation/compliance services. Additionally, our division, TalentProcure, leads the industry with offerings such as High Hazard Payroll, Managed Services, and Vendor on Premise (VOP) solutions.
Due to our prioritization of excellent standards, we are Joint Commission Certified and are a certified Minority Business Enterprise (MBE) in the USA and Canada. Supporting over 130 Fortune 500 companies globally, we excel in navigating the landscape of talent acquisition. In a world of constant change, we embrace developing people-centric solutions that address the unique demands of our clients. Stay connected by visiting our website and following us on social media!
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