Cathryn Faulring, Rd Email & Phone Number

Durham, North Carolina, United States

United States

Raleigh-Durham, North Carolina Area

Hopkinton, Ma

Responsible for providing responses to requests for medical information and designing procedures and systems to identify, review, update and track responses to frequently asked questions (FAQ's). Ensures that all product complaints and adverse event reports are assessed, processed and reported according to company and regulatory timelines and guidelines. Interacts with Sales Support, Sales, Pharmacovigilance, Quality Assurance, IT, Medical Consultants, Legal and other divisional functional areas to obtain information necessary to respond to medical inquiries. Coordinates development of procedures and systems to track and update FAQs. Participates in development of medical information policies. Maintains oversight of a CRO for tracking and data entry of adverse event data into an electronic safety database (ARISg); includes quality checks of data/date entry.Brings serious or potentially serious adverse events, complaints, and any Pharmacovigilance related issues to the attention of management in a timely manner.Designs and enters data into departmental tracking systems; includes quality control checking of data. Participates in Pharmacovigilance and medical information audits and responds to audit findings, including corrective actions.Demonstrates a comprehensive understanding of all applicable regulations.Functions as a departmental and company resource regarding medical information inquiries. Participates in professional and department meetings including providing data, assessment, and recommendations for improvement.Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes.

Clinton, Ma

Assists Regulatory Compliance Manager with all matters associated with food law, food labeling law, packaging law, and environmental law in the U.S. and Canada. Assist the RCM in interfacing with customers and regulatory bodies on all associated matters. Assists in the input of data and information into customer electronic databases (web-based portals, e.g. iCix, TeE, AMIGOS).Provides product nutritional information using Genesis nutritional software.Assists in the review and approval of package copy and other material, e.g. promotional material and Weetabix web site information.Regulatory agencies, professional/trade groups assistance: Assists in interfacing with FDA, USDA, C & BP CFIA, GMA, AACC, 1FT, and other entities through internet or direct contact. Product claims information: Assists in maintaining health and product attribute claims for all Weetabix products.

Marlborough, Ma

Conduct, track, and document due diligence with reporters in the form of emails, phone calls, and/or letters in order to collect adequate clinical information. Provide presentations and conduct training at Investigator Meeting and CRA training to facilitate clinical study start activities. Complete accurate data entry into Oracle AERS safety database per department established working practice instructions, conventions, and processes. Determine appropriate regulatory reporting requirements in accordance with global regulations and guidelines (FDA regulations, ICH guidelines, etc). Determine regulatory reporting requirements based on individual case assessments of seriousness, causality, and expectedness/listedness in accordance with regulatory guidelines and product labeling.Accurately select event terms using clinical judgment, determine seriousness, and assess expectedness/listedness based on labeling documents. Maintain accurate and thorough documentation in order to ensure good audit practice in compliance with GCP, GMP, ICH, Federal US, and any pertinent local regulations.Conduct quality reviews of non-serious cases in order to ensure quality and consistency of information. Ensure compliance with regulatory timelines for individual expedited case reports submissions and timely delivery of information for aggregate reports and other regulatory documents as requested.Complete timely diligence, review, and processing of adverse event reports as requested in order to fulfill all regulatory reporting obligations.

Marlborough, Ma

Conduct, track, and document due diligence with reporters in the form of emails, phone calls, and/or letters in order to collect adequate clinical information.Provide presentations and conduct training at Investigator Meeting and CRA training to facilitate clinical study start activities.Complete accurate data entry into Oracle AERS safety database per department established working practice instructions, conventions, and processes.Determine appropriate regulatory reporting requirements in accordance with global regulations and guidelines (FDA regulations, ICH guidelines, etc).Determine regulatory reporting requirements based on individual case assessments of seriousness, causality, and expectedness/listedness in accordance with regulatory guidelines and product labeling.Accurately select event terms using clinical judgment, determine seriousness, and assess expectedness/listedness based on labeling documents.Maintain accurate and thorough documentation in order to ensure good audit practice in compliance with GCP, GMP, ICH, Federal US, and any pertinent local regulations.Conduct quality reviews of non-serious cases in order to ensure quality and consistency of information.Ensure compliance with regulatory timelines for individual expedited case reports submissions and timely delivery of information for aggregate reports and other regulatory documents as requested.Complete timely diligence, review, and processing of adverse event reports as requested in order to fulfill all regulatory reporting obligations.

Natick, Ma

Clinical data review, data discrepancy listings and data clarifications on intermediate complexity projects using Electronic Data Capture.Document, resolve, and integrate data queries while interacting with project team/teams. Involved in testing of validation programs (logic checks) to ensure database quality and integrity.

Maynard, Ma

Clinical data review, data transfers and data clarifications on intermediate complexity projects using a SQL/SAS datasets.Liaison between Client/Sites/CRO for data discrepancies. QC and auditing of clinical trial subject files.

Waltham, Ma

Clinical data review/data clarifications on intermediate complexity projects using OC/Clintrial.Document, resolve, and integrate data queries while interacting with project team/teams.Review of data discrepancy listings, with query documentation and resolution.Editing the database and the Case Report Form (CRF).Performed QC of the CRF against the database. Involved in testing of validation programs to ensure database quality and integrity. Liaison between Client/Site/Safety for associated Serious Adverse Event Reconciliation.

Collected and corrected menus for modified diets.Supervised cafeteria workers on a tray line.Updated diet orders using a computerized order/entry system.

Maintenance and sanitation aboard a 270' Coast Guard Cutter.Administrative duties at a Coast Guard communications station.