Stacy Downing Email & Phone Number

Nashville, Tn, Us

Primary pharmacovigilance (PV) (safety) representative and contact for Sponsors, investigational sites, and Sarah Cannon Development Innovations (DI) project teams. Reviews safety sections of clinical study protocols, and is responsible for ensuring the appropriate safety reporting process is in place, and ensures compliance with global PV regulations, guidelines (e.g. ICH) and company policies. Appropriately escalating safety related issues Accountable for delivery of a detailed Safety Monitoring Plan (SMP) for clinical studies, describing the end-to-end process for safety reporting, compliant with study protocol, Sponsor requirements, and applicable PV regulations. Reviews safety case reports to ensure Argus safety database entry is complete and accurate, prepares a comprehensive and medically coherent clinical narrative for safety cases, determines the expectedness of an event for regulatory reporting purposes, codes medical terminology using standardized dictionary (e.g. MedDRA), and identifies queries required for accurate assessment. Prepares expedited individual safety reports, submits to relevant competent authorities (e.g. EMEA, MHRA), and is responsible for ensuring further submissions via sponsor or regulatory function e.g. FDA and site EC/IRB. Leads regular cumulative safety reviews for studies, defines and ensures delivery of supporting safety outputs (TLFs), reviews safety data and drafts a summary, works with Safety Physician and Medical Monitor to finalize meeting content, presents data at cross-functional safety review meeting Conduct all activities according to the company SOPs, GCPs, ICH regulations and guidelines.

Raleigh, North Carolina, Us

Conduct daily case processing of adverse events, conduct follow up, write accurate and complete narratives in accordance with internal guidelines, SOPs and US safety regulations. Maintain distinctive quality and commitment as the operating philosophy in carrying out all processes. Prepare written communications to obtain follow-up information. Prepare, Write case narratives and review MedWatch/CIOMS/E2B reports. Complete client notifications as required for case management. Develop training materials, conduct training presentations and on-the- job-training.

Durham, North Carolina, Us

Assisted in processing of Lifecycle Safety data by collection and tracking incoming Serious Adverse Events of initial/ follow up status of incoming events, tracking timelines for completion of event processing.• Distributed event information to appropriate project personnel in the workflow for continued processing, review, and preparation of endpoint documentation. Transferred events to client and other parties as identified by operations lead, obtaining confirmation of report receipt and tracking submission and assuming workflow responsibilities for various projects.• Assisted with project workflow including database entry, quality control activities. Led reconciliation and generation of Lifecycle Safety data reports, preparation of Lifecycle Safety submissions, assisting with deadline quality measurements.• Coordinated, scheduled, and submitted safety reports to regulatory, and partners in accordance with deadlines.• Created, maintained, and tracked case folders, filing, retrieving and distribution of case folders to operations team members, assisting in maintenance of document control storage and relevant applications/systems as directed.• Created project tracking sheets for case tracking entry specifications.• Assisted in database validation through performance of user testing, where required. Identified and recorded process or quality problems and bring them to the attention of designated IT team member. • Participated in continuous improvement of all departmental processes and procedures by identifying and implementing efficiencies in workflow and/or case processing. Contributed in local/global department committees. Provided training/coaching to new and/or less experienced staff.• Coordinated, oversaw, and delegated resource tasks to administrative team members as appropriate and monitored intake of cases and archiving process when multiple coordinators were involved.

Durham, North Carolina, Us

Durham, North Carolina, Us

Managed 25 contacts international and US. Ensured daily adhoc request were addressed from client/team. oDetermined initial/ follow up status of incoming SAEs; for relatedness and unrelated events, Suspected Unexpected Serious Adverse Reactions (SUSARs).oScheduled expedited and non-expedited timelines per country specific regulatory guidelines, relatedness, SUSARs and track report submissions. Issued queries to escalated to site(s) for possible SUSARs on reported events. oPerformed project maintenance with data cleaning of case reconciliation, query management. Escalated queries on a daily to monthly basis to study CRAs, coordinators, principal investigators, to various sites.oQuality controlled query issuance to ensure 1:1 ratio is met and maintain between ARGUS and EDC. For sites to resolve pending queries and to close numerous cases, prepare for database lock. oPulled answered queries manually on daily basis, perform reconciliation daily of report SAEs, NonSAEs, and Answered queries reports. oAssisted with book in data entry, inital, follow up data, utilized MedDRA coded adverse events terms under perferred term /lowest level term. Coordinated, scheduled and submitted reports to regulatory authorities in accordance with established deadlines.oCo-ordinate and checked incoming documents from sites; ensured documents met requirements. oCommunicated with CRAs regarding project requirements. Request urgent updates from the sites.oCreated job aids to assist with mentoring team members with onboarding, daily task. oPromoted the understanding of work instructions for use of all relevant electronic systems and maintenance of records. oPerformed work in accordance with governing SOPs, work instructions, regulatory requirements, and Safety Management Plan.oUtilized ARGUS, Inform (EDC), LS Apex Tracker, RAVE, SharePoint Workflow Task log, Clinical Trials Management Systems (CTMS), MedDRA, IBM Clinical (Merge eClinicals), OneNote.

Coordinated operations and provided support to the records and imaging center. Provided reference services to all departments and personnel and distribute incoming information for integration into systems.oDocuments reviewed e.g. Financial Disclosures, Regulatory document 1571 and 1572, Site visit logs, core and country documents, IRB documents, medical license, certifications, investigator site affiliations, ICH GCP training, and Inform Consents. Reviewed studies for phase III for Cystic Fibrosis, and Diabetes Mellitus.oBatch, registered, quality controlled documents for pagination, image quality, inventory documents for client’s inventory storage. Utilized EEL Content and ELVIS DIA/ Pre DIA.oEnsured effective security, storage, and retrieval of all proprietary and client information in accordance with established procedures. Includes usage of scanning equipment.oConducted imaging/scanning and train on imaging/scanning processes. Provided reference services to internal clients in accordance to SOPs and by maintaining accurate charge-out systems. oSorted and classified coded material for filing. Created files according to established classification system. oMaintained logs and enter metadata in database to track status and facilitate accurate retrieval of information.

Provided data entry and case processing for adverse event reports, for pregnancy, spontaneous, post marketing, and clinical trial in safety tracking systems, IRT and ARISg safety database, manage electronic documents and update database files accordingly.oProvided quality control review of documents, electronically fax documents to sites, upload documents in database follow the 21 CFR part guidelines for maintenance of electronic records, electronic signature, validation for audit.oSuccessful data migration into ARISg with meticulous work.oEscalated correspondence with personnel such as healthcare providers, consumers, and sent notification to other manufacturers regards to patients who experienced adverse events while taking study drugs for Crohns and Multiple Sclerosis, Autoimmune diseases and Cancer. oPerformed a variety of task simultaneously, including those with set deadlines, and daily metrics. Work effectively within a team attained a shared goal and problem solver.

Sant Cugat Del Vallès, Barcelona, Es

Identified and communicated the initial receipt of adverse event data notification. Supported other drug safety team members with drug safety projects and pharmacovigilance data cleanup. Followed the GXP guidelines of 21 CFR part 11 acknowledge, date stamped documents, electronic signature validation and maintenance of electronic records.Prepared clinical case file, enter data into (BDSS) Biologics Drug Safety System. Prepared, updated cases status log for morning meetings. Quality Control cases after data entry has been completed. Trackwise (ITS) entry and Database updates. Monitored pending cases daily in medical review; identify cases approaching the Global Data Safety periods, 7-day alert and 15-day deadline for regulatory submission.Prepared batch lot line listings, SAP reports of batch listings, code event terms using MedDRA, code drugs to WHO drug dictionary as necessary, according to project specific guidelinesRedacted all confidential patient information from the received reports. Recorded protocol number and site/patient number, if applicable, on all source documents. Entered data into safety database ensure accurate entry of adverse events received from patients and/or Patient Support Programs using Immunoglobin and Anti-trypsin products such as Gamunex, IGIVnex, Flebogamma Dif, Prolastin-C, Fandhi, Hemophilia, Factor VIII.

Prepared case records for each consumer referred to the rehabilitation and transition programs.oAnswered multiline phones, greet patients, scheduled appointments and handled insurance precertification, and assisted in upkeep and management of patient medical records and agency files.oHelped maintain client recall program, ensuring accuracy of daily data entry and tracking 12,000 + clients and their follow-up schedules, for inquiries about the program assistance.oImproved the organization of client files and practice records, instituting new systems and processes that saved time, minimized errors and accelerated insurance payments.oResolved patient issues diplomatically and expediently to ensure customer satisfaction, always keeping patient confidentiality a priority. Advanced word processing, spreadsheets, and access database applications.oEntered $2.7 million requisitions into the North Carolina E-Procurement application for supplies, services, contractual vendor services for conferences, program initiatives for projects.

Bachelor Of Science, Speech Pathology/ Audiology

Nondegree, Medical Insurance Coding Specialist/Coder

Nondegree, Pharmacy Technician/Assistant

Non-Degree, Clinical Research Associate