Project Coordinator Job at BRS
The Centers for Disease Control and Prevention’s (CDC) mission is to promote the health and quality of life by preventing and controlling disease, injury, and disability. As part of this mission, CDC is tasked with implementing programs to ensure that people will live safer, healthier lives through protecting Americans from health threats via a prevention, detection and response network and establishing CDC as the trusted and effective resources for health development. CDC addresses critical public health challenges through working with a diverse set of partners to support the development and implementation of public health interventions.
CDC provides leadership to improve the health of people in all life stages and in all settings. It carries out this role by monitoring health, developing health improvement strategies, providing financial and technical assistance to partners and conducting other activities. There are major programs that have been implemented globally within the last several years that have greatly expanded the global mission of the CDC and have prompted the need for increased services and staffing domestically to support those activities. As more health crises are identified, the mission and response of CDC’s operating divisions have expanded.
In part of the response to the global COVID-19 pandemic, the United States has introduced a national mass COVID-19 vaccination program. Over a 100 million American citizens already vaccinated and there is a goal of vaccinating the U.S. population by early summer. As vaccine safety monitoring is a critical component to any vaccination program, for COVID-19 vaccine safety monitoring efforts are the most intense and comprehensive in U.S. history. CDC is relying on established monitoring programs including the Vaccine Adverse Event Reporting System (VAERS) and the Clinical Immunization Safety Assessment (CISA) Project to offer . Because of these efforts, additional staffing is needed to support CDC’s efforts in VAERS and v-safe safety activities.
Vaccine Adverse Event Reporting System (VAERS)
VAERS is a mandated program sponsored jointly by the Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA). The purpose of this project as authorized by the National Childhood Vaccine Injury Act (NCVIA), P.L. 99-660, is to provide a single nationwide mechanism to report, analyze and monitor vaccine adverse events (VAEs) that occur after receipt of vaccines. It also provides a vehicle for disseminating vaccine safety information to vaccines, family members, health care providers, vaccine manufacturers, government agencies, and other partners.
VAERS contains reports of VAEs based on two criteria, mandated and voluntary reports. The events mandated for healthcare provider and vaccine manufacturer reporting are listed in the Reportable Adverse Events Table (RET) available at: https://vaers.hhs.gov/docs/VAERS_Table_of_Reportable_Events_Following_Vaccination.pdf
US- manufacturers of vaccines are mandated by 21 CFR Part 600.80 (Attachment 3) to submit reports routinely on a periodic basis, as well as in an expedited manner for more serious events. In addition, healthcare providers are encouraged to report all other clinically significant VAEs following the administration of any US vaccine in all age groups. For all reports, the impetus for reporting is not a presumed causal relationship between the vaccination and the event but may be based simply on the occurrence of the event temporally following vaccination and the lack of other obvious causes.
From 2015 through 2019, VAERS received an annual average of 58,000 reports, of which 49,000 were US reports. Of the US reports, 5.3% were classified as serious (i.e., associated with disability, hospitalization, prolongation of existing hospitalization, life-threatening illness, congenital anomaly/birth defect, or death [21 CFR 600.80]). Since 1990 to 2019, VAERS has received over 810,000 reports, most of which describe mild and self-limited adverse events such as injection site reactions and fever. (VAERS government data archive January 29, 2021.) VAERS helps to identify important new safety concerns and thereby can help inform vaccine policymakers and healthcare providers. In addition, the data are valuable for regulatory actions and vaccine research studies. The US Government considers post-licensure/authorization surveillance for any licensed and new vaccines through VAERS to be a nationally critical function, and the US Government considers the requirements of the VAERS activity to constitute essential services for which any lapse in coverage of services would be unacceptable.
The current COVID-19 pandemic and COVID-19 vaccination program have created additional requirements for VAERS. Specifically, as part of a mass immunization program with a goal to immunize every adult by May 2021, VAERS has had a surge in reporting of adverse events as compared to previous years and to other vaccines. In addition, CDC reviews reports that are coded as Adverse Events of Special Interest (AESI). These AESI include: acute myocardial infarction, anaphylaxis, coagulopathy, death, Guillain-Barré Syndrome, Kawasaki Disease, Multisystem Inflammatory Syndrome (in adults and in children), myopericarditis, narcolepsy, pregnancy, seizure, stroke, transverse myelitis, Bell’s palsy, and appendicitis. Additional outcomes are added, as potential concerns following COVID-19 vaccination are identified.
The VAERS Project coordinator will provide oversight to all medical officer/epidemiologist support services for the VAERS program. Tasks include:
1. Working with CDC staff, the contractor will gain access to the VAERS VPN and the internal CDC VAERS abstraction website.
2. The contractor will be trained by CDC staff on VAERS, using the VAERS VPN, how to review VAERS reports, how to conduct medical record abstraction, and how to enter data into the internal CDC VAERS abstraction website.
3. Working with CDC staff, the contractor will review VAERS AESI reports. Up to 25 VAERS reports will be assigned per day for review.
4. The contractor shall perform a review of available VAERS reports and associated medical records, if available, for each assigned report.
5. The contractor shall perform data entry from the assigned reviews. These reviews will be via CDC electronic form, consisting mostly of check boxes and free text fields. The medical record review will determine if the reported AESI meets a published case definition (if available). Medical record reviews will follow CDC VAERS Standard Operating Procedures. All published case definitions will be provided to the contractor.
6. The contractor shall request medical records from health care providers/systems located in the United States on behalf of VAERS.
7. The contractor shall conduct literature reviews on new vaccine safety outcomes of concern or AESI.
8. The contractor shall respond to inquiries received by the public, health departments, and providers. This may include reviewing the VAERS database, conducting literature reviews to provide published data as it pertains to the inquiry, and drafting a response to the inquiry. The response will be shared with the CDC VAERS inquiries lead and the VAERS team lead or designee.
9. The contractor shall work with CDC VAERS staff to resolve any questions or concerns related to VAERS reviews.
Please Note :
www.bankofmontserrat.ms is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, www.bankofmontserrat.ms provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.
CDC provides leadership to improve the health of people in all life stages and in all settings. It carries out this role by monitoring health, developing health improvement strategies, providing financial and technical assistance to partners and conducting other activities. There are major programs that have been implemented globally within the last several years that have greatly expanded the global mission of the CDC and have prompted the need for increased services and staffing domestically to support those activities. As more health crises are identified, the mission and response of CDC’s operating divisions have expanded.
In part of the response to the global COVID-19 pandemic, the United States has introduced a national mass COVID-19 vaccination program. Over a 100 million American citizens already vaccinated and there is a goal of vaccinating the U.S. population by early summer. As vaccine safety monitoring is a critical component to any vaccination program, for COVID-19 vaccine safety monitoring efforts are the most intense and comprehensive in U.S. history. CDC is relying on established monitoring programs including the Vaccine Adverse Event Reporting System (VAERS) and the Clinical Immunization Safety Assessment (CISA) Project to offer . Because of these efforts, additional staffing is needed to support CDC’s efforts in VAERS and v-safe safety activities.
Vaccine Adverse Event Reporting System (VAERS)
VAERS is a mandated program sponsored jointly by the Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA). The purpose of this project as authorized by the National Childhood Vaccine Injury Act (NCVIA), P.L. 99-660, is to provide a single nationwide mechanism to report, analyze and monitor vaccine adverse events (VAEs) that occur after receipt of vaccines. It also provides a vehicle for disseminating vaccine safety information to vaccines, family members, health care providers, vaccine manufacturers, government agencies, and other partners.
VAERS contains reports of VAEs based on two criteria, mandated and voluntary reports. The events mandated for healthcare provider and vaccine manufacturer reporting are listed in the Reportable Adverse Events Table (RET) available at: https://vaers.hhs.gov/docs/VAERS_Table_of_Reportable_Events_Following_Vaccination.pdf
US- manufacturers of vaccines are mandated by 21 CFR Part 600.80 (Attachment 3) to submit reports routinely on a periodic basis, as well as in an expedited manner for more serious events. In addition, healthcare providers are encouraged to report all other clinically significant VAEs following the administration of any US vaccine in all age groups. For all reports, the impetus for reporting is not a presumed causal relationship between the vaccination and the event but may be based simply on the occurrence of the event temporally following vaccination and the lack of other obvious causes.
From 2015 through 2019, VAERS received an annual average of 58,000 reports, of which 49,000 were US reports. Of the US reports, 5.3% were classified as serious (i.e., associated with disability, hospitalization, prolongation of existing hospitalization, life-threatening illness, congenital anomaly/birth defect, or death [21 CFR 600.80]). Since 1990 to 2019, VAERS has received over 810,000 reports, most of which describe mild and self-limited adverse events such as injection site reactions and fever. (VAERS government data archive January 29, 2021.) VAERS helps to identify important new safety concerns and thereby can help inform vaccine policymakers and healthcare providers. In addition, the data are valuable for regulatory actions and vaccine research studies. The US Government considers post-licensure/authorization surveillance for any licensed and new vaccines through VAERS to be a nationally critical function, and the US Government considers the requirements of the VAERS activity to constitute essential services for which any lapse in coverage of services would be unacceptable.
The current COVID-19 pandemic and COVID-19 vaccination program have created additional requirements for VAERS. Specifically, as part of a mass immunization program with a goal to immunize every adult by May 2021, VAERS has had a surge in reporting of adverse events as compared to previous years and to other vaccines. In addition, CDC reviews reports that are coded as Adverse Events of Special Interest (AESI). These AESI include: acute myocardial infarction, anaphylaxis, coagulopathy, death, Guillain-Barré Syndrome, Kawasaki Disease, Multisystem Inflammatory Syndrome (in adults and in children), myopericarditis, narcolepsy, pregnancy, seizure, stroke, transverse myelitis, Bell’s palsy, and appendicitis. Additional outcomes are added, as potential concerns following COVID-19 vaccination are identified.
The VAERS Project coordinator will provide oversight to all medical officer/epidemiologist support services for the VAERS program. Tasks include:
1. Working with CDC staff, the contractor will gain access to the VAERS VPN and the internal CDC VAERS abstraction website.
2. The contractor will be trained by CDC staff on VAERS, using the VAERS VPN, how to review VAERS reports, how to conduct medical record abstraction, and how to enter data into the internal CDC VAERS abstraction website.
3. Working with CDC staff, the contractor will review VAERS AESI reports. Up to 25 VAERS reports will be assigned per day for review.
4. The contractor shall perform a review of available VAERS reports and associated medical records, if available, for each assigned report.
5. The contractor shall perform data entry from the assigned reviews. These reviews will be via CDC electronic form, consisting mostly of check boxes and free text fields. The medical record review will determine if the reported AESI meets a published case definition (if available). Medical record reviews will follow CDC VAERS Standard Operating Procedures. All published case definitions will be provided to the contractor.
6. The contractor shall request medical records from health care providers/systems located in the United States on behalf of VAERS.
7. The contractor shall conduct literature reviews on new vaccine safety outcomes of concern or AESI.
8. The contractor shall respond to inquiries received by the public, health departments, and providers. This may include reviewing the VAERS database, conducting literature reviews to provide published data as it pertains to the inquiry, and drafting a response to the inquiry. The response will be shared with the CDC VAERS inquiries lead and the VAERS team lead or designee.
9. The contractor shall work with CDC VAERS staff to resolve any questions or concerns related to VAERS reviews.
Please Note :
www.bankofmontserrat.ms is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, www.bankofmontserrat.ms provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.