Resume

Sign in

Data Entry Assistant

Location:
New York, New York, United States
Posted:
January 23, 2018

Contact this candidate

Resume:

Joseph Torres

*** * **** *

Street, Apt. PHH

New York, NY 10035

Cell Phone 212-***-****

ac35gm@r.postjobfree.com

Objective: To obtain a position that allows me to apply my skills as a Regulatory Safety Associate, Clinical Safety Assistant/Technical Associate/, or a Position that fits my Skills and Experience. Professional Experience:

USPS New York, NY

Letter Carrier Assistant 03/2009-Present

● Preparing mail for delivery by sorting or casing up in address and number order.

● Sorting packages for delivery by address and parcel type

● Packing and filing mail by building order in a cart for delivery

● Delivering mail by apartment order and building sort order

● Driving to Deliver packages by route to different addresses, by scanning and requesting signatures Pfizer New York, NY

Drug Safety Associate, Drug Safety Assistant 09/1996-01/2009

● Coordinated with the therapeutic team, with the triage and case review process, by using the AEM form based on 15 blocks including a narrative and comments block. Determined seriousness, expectedness, and type of report for adverse events by following the SOP guidelines, while staying up to date on current practices and processes through familiarization with doc-central SOP’s

● Completed training for Medra, Who-Drug dictionaries

● Familiarized with the ARISg/Cases Exception Reports by running Global, PSUR, and Periodic reports for two therapeutic teams that were assigned to me

● Identified missing information needed to submit a Medwatch form to the FDA by follow-up letter or calling the reporter of the Adverse Event.

● Performed initial and follow-up priority 2 to 5 serious and non-serious reports in ARGUS database.

● Cross referenced with case receipt to check for duplicate reports and then reconciled.

● Confirming Subject Drugs, concomitant drugs, NDA numbers, labeling for expectedness,

● Provided input in regards to the pagination of literature report articles; assisting the creation of instructional documents concerning the literature article pagination process

● With regard to the German Cefoperazone Project/Protocol number assigned me, I performed database corrections per RSA Regulatory Safety Associate instructions on 54 individual reports in ARISg, in regards to the updating of Project/Protocol numbers. Additionally, I entered case dialog comments for each of these cases as well

● Expedited the corrections of 201 individual protocol numbers and added case dialog comments to these Unasyn injection cases. This was accomplished in 24 hours in addition to my regular team volume, and during a period of time when challenges with access to the ARISg database was being experienced

● Took initiative in running the Team Global Reports, and in addition to the regular running of the AI/A team ad hoc exception reports, all while handling daily data coordination issues regarding case processing, including poison control cases and voriconazole database reconciliation’s

● Worked with the therapeutic team with the data entry of reports in a timely manner to meet compliance.

● Supporting the seamless process by staying up to date on current practices and processes through familiarization with doc-central SOP’s.

● Completed training for Medra, Who-Drug dictionaries.

● Familiarized with the ARISg/Cases Exception Reports by running Global, PSUR, and Periodic reports for two therapeutic teams that were assigned to me.

● Provided input in regards to the pagination of literature report articles; assisting the creation of instructional documents concerning the literature article pagination process.

● With regard to the German Cefoperazone Project/Protocol number assigned me, I performed database corrections per RSA Regulatory Safety Associate SOP’s on 54 individual reports in ARISg, in regards to the updating of Project/Protocol numbers. Additionally, I entered case dialog comments for each of these cases as well.

● Expedited the corrections of 201 individual protocol numbers and added case dialog comments to these Unasyn injection cases. This was accomplished in 24 hours in addition to my regular team volume, and during a period of time when challenges with access to the ARISg database was being experienced.

● Took initiative in running the Team Global Reports, and in addition to the regular running of the AI/A team ad hoc exception reports, all while handling daily data coordination issues regarding case processing, including poison control cases and voriconazole database reconciliation’s.

JUDGMENT:

I have demonstrated the capability of Judgment by: Daily prioritization of cases within the workflow by target completion date (TCD), and case type; raising issues with Lead MDC medical data coordinators regarding the workflow, and the ARISg database when encountering missing or conflicting data, bringing it to the appropriate RSA regulatory safety associate to address the issue, or noting it on the Triage Form; Understanding the broader implications of actions as they relate to other functional groups; recognizing possible errors in data or terms presented for data entry. Communicating with the RSA’s about missing or incomplete data. I have the experience to recognize when a specific part of data specified on a report is questionable or just wrong, and will then take the initiative to communicate with the specific RSA regulatory safety associate who reviewed the case to make the change or complete the missing data. Whenever the RSA is not available I will then specify what was questionable on the Triage form so that the change can be made during the proofing Quality Control stage. ORGANIZATIONAL AWARENESS:

I have demonstrated the capability of Organizational awareness by: Understanding the workflow and who is responsible for the various team functions; staying up to date with changes in the workflow and the company as a whole; knowing whom to contact in order to address specific issues. I have stayed up to date with the Standard Operating Procedures on any changes in the way to process priority reports. Including Pfizer legacy Priority 5, Literature reports, Solicited, and Registry. PROBLEM SOLVING:

I have demonstrated the capability of Problem Solving by: Identifying data entry issues and working out solutions with other team members and Leads; resolve problems on my own with the help of the RSA involved, especially when working on a deadline; Maintaining a log of issues to raise during the monthly data coordination meetings; working with the IT group regarding the pagination of literature report articles from eAEM, including identifying the need for the installation of an upgraded Adobe Acrobat for the members of the Data Coordination group; communicated with departmental managers and consultants to identify requirements to accomplish the Literature article pagination task; participated in creation of an instruction manual for the pagination project. Stayed up to date regarding the data entry mapping versions, and provided feedback regarding necessary changes. Became an SME after mentorship in ARGUS database during the migration process of the data from Arisg to ARGUS to comply with the single stream process. I also produced exception reports in regards to missing or inconsistent data by querying ARISg to produce the appropriate ARISg/CASES exception reports. The accuracy of these queries ensured cleaning of the reports by RSA’s Regulatory Safety Associates who receive the Exception Reports. I noticed a trend in regards to a new drug called Trovan

(trovafloxacin) where adverse events were reported concerning Pancreas and Liver damage. The FDA instructed the company to attach a form called Hepatic and Pancreatic Issues to any of these cases which in the long run saved the company from receiving any fines from the FDA as compliance was met. PRESENTATION:

I demonstrated the capability of Representation by: Mentoring new MDC’s medical Safety Data Coordinators and kept the Lead MDC appraised of their progress; provided the Lead MDC with ongoing information regarding case volume and team resourcing; attended meetings in lieu of Lead MDC and reported back; represented the Data Coordination group at meetings in Lead MDC’s absence. Served as a SME Subject Matter Expert during the migration from the AEM database to the ARISg database. This transition was done while maintaining compliance during a very high volume. Also assisted with questions and solutions as a mentor. I also continued to serve as the departmental Subject Matter Expert (SME) regarding the Literature report pagination process, and User Acceptance Testing (UAT). Became proficient in the process of the AEM form, Triage form, Cioms/3500 form, and PSUR Periodic Reports form. Became proficient in the use of eAEM, ARISg, ARGUS, on the CITRIX server, and the use of Adobe Acrobat, Microsoft Word, Excel, and the MEDdra and WHODRN Dictionaries. Education:

2014-Present: Bachelor of Psychology, at Southern NewHamphire University, New Hampshire 2012-2013: Medical Assistant, at Mildred Elley College, New York, New York Attended Full-Time Evening, Physiology, Hematology, and Nursing courses 2008: Holt Training: Advanced Project Management PMI Institute 16 CEU Credits 2007: Holt Training: Project Management PMI Institute 14 CEU Credits 2006: Holt Training: Leadership Series I,II,III, and IV 2005: Holt Training: Windows XP

2004: Holt Training: Center point software training 2001: Holt Training: Windows Server 200

99 - 2000: Forefront Direct = Computer Based Learning for MCP Windows NT Server 4 01/03/00: Prometric COMP-TIA = A+ Certificate/Computer Technician 1999: Brain Bench = Computer Technician Certificate 1994 - 1995: ICS Correspondence Schools = A+ Certification Course 1995: NRI Schools = Word Processing and Desktop Publishing Course Awards = Attendance, Outstanding Performance

1993: New York City Department of General Services = Word Perfect Internship Awards = Attendance, Outstanding OJT Performance

1993: High School Diploma = GED, Valedictorian, Brooklyn 1993



Contact this candidate