Grifols Shared Services North America, Inc Drug Safety Coordinator/Sr. Drug Safety Coordinator in Clayton, North Carolina
For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.
Serves as Global Drug Safety team member. 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.
Hiring Manager : Cindy Banks
Position Level: N7/N8
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 meetingsb. 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 person conducting case owner
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 person conducting case owner
The Drug Safety Coordinator is the first person in GDS 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.
Drug Safety Coordinator : Associate Degree, and 2-3 years of recent experience in a clinical setting or equivalent in experience or training. Clinical drug development experience preferred.
Sr. Drug Safety Coordinator : Associates Degree or a Bachelor's Degree in a relevant curriculum is preferred. 3 years of experience in the pharmaceutical/biotech industry preferably in the area of quality, regulatory, manufacturing/supply, information systems, clinical or drug safety, or an equivalent combination of education and experience is required.
Location: [[mfield6]] : [[cust_building]]
Learn more about Grifols at http://www.grifols.com/es/web/international/home
Req ID: 83938
Type: Regular Full-Time
Job Category: Pharmacovigilance