Grifols Shared Services North America, Inc 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 reviewing and identifying incoming reports within the Global Pharmacovigilance (GPV) inbox and processing 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) in building team environment among assigned staff and between other departments. Assists the case managers by providing supportive tasks necessary to move adverse event cases through the work flow to a finalized state. Helps ensure the timeliness of regulatory submissions of adverse event reports.
Primary Responsibility and Role:
● 1. Monitor the GPV inbox and fax machine for incoming adverse events, track and file source documents as appropriate.
a) Enter the case into the tracking log, check whether it is an initial, a follow-up, or a duplicate report and place the case in the appropriate folder
b) Create a new folder when required for an initial case and label it as appropriate
c) Identify and delete all confidential patient privacy information from any incoming reports
d) Record protocol number and site/patient number, if applicable, on all source documents
e) Provide the report to the person conducting case evaluation
● 2. Enter data into the safety database ensuring accurate entry. Perform electronic or manual coding, as necessary, according to project specific guidelines.
● 3. Perform regulatory submissions of adverse events according to the provided guidelines. Ensure that the appropriate documentation is provided to all parties and is stored and in the designated place. Place confirmations acknowledgements from the authorities into the appropriate folder.●4. Provide support to other drug safety team members as needed with faxing reports, narratives and queries as necessary. ●5. Maintain a thorough understanding of the protocol and scope of work for clinical studies.
●6. Assist DSS with adverse event follow-up, case closure, and database reconciliation.
●Communicate problems and issues to Director/DSS in a timely manner.
●Actively participates any project team meetings as required, providing process improvement suggestions.
Adheres to required timelines for completion of adverse event data entry
Maintain a thorough understanding and strict adherence to GCP guidelines,regulatory reporting regulations and the departments processes and procedures
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 skills, flexibility, organizational skills, ability to prioritize, and computer proficiency required. Ability to multitask and work in a fast-pace environment.
2-3 years of recent experience in a clinical setting or equivalent in experience or training. Clinical drug development experience and drug safety databases is preferred.
Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.
Location: [[mfield6]] : [[cust_building]]
Learn more about Grifols at http://www.grifols.com/es/web/international/home
Req ID: 70738
Type: Regular Full-Time
Job Category: Pharmacovigilance