To obtain a position within a company that will allow me to use my educational, work and quality Administrative service skills to contribute effectively in a corporate environment.
Skill Highlights
Windows, Word, Excel, Rightfax, RSGT, Data Entry, filing, MedRa, Siebel GCP, SOP, MedRa, Siebel, ClinTrace, PEGA
Education
Newark Business Training InstituteCaldwell, NJExpected in 5/1995 ā āCertification in Word Processing:BOS/Word Processing - GPA:
Caldwell CollegeCaldwell, NJExpected in 1989 ā ā:Psychology - GPA:
Psychology
Arts High SchoolCaldwell, NJExpected in 6/1987 ā āHigh School Diploma:Drama/College Prep - GPA:
Professional Experience
PPD - Safety Administrator II-Contract City, STATE, 01/2015 - 06/2015
Provides primary safety support to Pharmacovigilance staff including receipt of information, copying, filing, typing and distribution of letters, memos, reports, sending faxes and mailings, etc.
May perform any or all of the following functions: Creates and tracks safety report submission packets Completes initial data entry of adverse events in the safety tracking system and/or safety database Logs and forwards information received at the Incoming Information Center (IIC) to the designated teams Logs information into tracking systems.
Uploads documents received within the designated document repository Distributes project reports to the client and project team.
Assists in the collation of study metrics for the team and archival of project documentation at closeout Assists with maintenance of project specific training manual/matrix Manages logistics and coordinates meetings for endpoint assessment committee/Data Safety Monitoring Committee Assists in the set-up and management of program information through an administrative filing system so that information is readily available and accessible Assists with audit readiness Assists in training new safety support staff in department administrative and program-related tasks Maintains departmental office supplies; Assists with travel and meeting arrangements for staff as needed; Performs other duties as assigned.
Zucker, Goldberg & Ackerman - Data Entry Specialist-Temporary City, STATE, 09/2013 - 01/2014
Process and Data Enter of checks from homeowners seeking renewal on their home loans.
Process forclosures and maintain excel spreadsheets on procedures.
Celgene - Registration Representative-Contract City, STATE, 10/2012 - 02/2013
Enroll prescribers into the database by reviewing Enrollment Forms for accurate information.
Entering the data into the system accurately and within a specific time frame.
Knowledge of REMS programs/registrations processes for Pomalyst(pomalidomide).
Verizon/Solix Inc - Data Entry/Customer Service Representative-Temporary City, STATE, 2011 - 2012
Input data from email sales of cellular phones.
Troubleshoot , find solutions to email inquires.
Data entry customer information.
Answer inquires via inbound calls.
Bracco Diagnostics - Drug Safety Specialist-Contract City, STATE, 08/2009 - 11/2009
Prepared individual case file folder.
Complete and check data entry of adverse event reports into database (currently web-based ClinTrace Version 4.1) for completeness and accuracy.
Initiated internal tracking record for report (Darwin) Auto code adverse event terminology using MedDRA dictionary Notify Professional Services of ClinTrace record number for cases associated with a product query Track wise number.
Scan adverse event reports and send as an e-mail to the Medical Director for review throughout the day as required.
Provided daily administrative support to the Drug Safety department.
This includes, but is not limited to:Scan incoming serious reports, use PDF converter and produce a Word document of the reports; filing; photocopying; maintaining supplies for Drug Safety; maintaining file cabinet logbook.
Wyeth - SAE Specialist-Contract City, STATE, 09/2008 - 02/2009
Daily coverage and review of incoming SAE reports by fax and other sources including holiday coverage, as needed.
Assisted with the preparation and post meeting.
Assisted with archiving of the SAEsandfollow-up documentation and AE Review Meeting minutes.
Narrative writing.
Data Steward- Contract.
Hoffman La Roche - Data Steward-Contract City, STATE, 09/2006 - 11/2008
Working on a team, processing and resolving data inquiries.
Resolved Inquiries by searching for and reviewing customer data, updating customer records, and updating inquiry records electronically for the sales force all over the country using Siebel 7.
Working with the sales force electronically submitting inquiries regarding their customers that require resolutions.
Data is processed, data issues are identified and resolved for unmatched customer records, duplicates, customer records missing specific identifiers, etc are made .
Berlex - Safety Data Coordinator- Contract City, STATE, 02/2006 - 05/2006
Managed cases report filing system, create case documents,file folders and monitor and receive transferred and oversee document distribution, retrieve files upon request of Safety Specialists.
Overseen Records Retention/archiving activities, monitor department fax machine for incoming case information and create cases folders and assures that case documents are properly identified, file generated documents and records activities in case folder.
Responsible for electronic transfer of appropriate ADRs in compliance with SOPs and WPs: Print transfer reports, accept appropriate cases, and print out MedWatch and CIOMS forms.
Inform& generate requests for follow up based on timing referenced in departmental SOPs.
CMed - Clinical Data Coordinator-Contract City, STATE, 08/2005 - 09/2005
Ensure trial documentation is reviewed e.g.
protocol, validation document and Case Record Forms (CRFs) and provide input as appropriate.
Ensure relevant working practices or standard operating procedures are adhered too (client and / or Cmed CRS).
Verified data entered into database.
Ensure ongoing data processing and highlight any issues that may affect data quality.
Identify errors or inconsistencies from standard data cleaning checks, reports and listings.
Pfizer - Compliance Coordinator-Contract City, STATE, 08/2004 - 05/2005
Supported of monthly quality assurance efforts in support of RSGT related activities.
Assumed the role of Expedited Letter Coordinator as required, assisting with the submissions of serious and unlabeled reports to the FDA Reviewed adverse event reports tracking data generated from Regulatory Group Tracking (RSGT) database.
Perform data entry and proofing in RSGT Support Therapeutic teams within Safety Surveillance and Reporting (SSR) relative to RSGT workflow tracking and problem solving Interact with internal (SSR staff) and external (SSR domestic.
Schering-Plough/Berlex - Information/Clinical Data Entry Coordinator-Contract City, STATE, 04/2003 - 04/2004
Assisted with the Drug Safety Specialist gathering information from consumers, doctors, health professional in the US and around the globe.
Enter Data from cases related to adverse events, clinical research and quality assurance.
MedDRA coding in accordance with guidelines and conventions Narrative writing OTC experience with Allergy products such as Claritin/Claritin D 100% Quality Control check listings; Verification of Data Entry Clintrial 4.3, performing system documents program/e-power on OTC products, Narrative writing.
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School Attended
Newark Business Training Institute
Caldwell College
Arts High School
Job Titles Held:
Safety Administrator II-Contract
Data Entry Specialist-Temporary
Registration Representative-Contract
Data Entry/Customer Service Representative-Temporary
Drug Safety Specialist-Contract
SAE Specialist-Contract
Data Steward-Contract
Safety Data Coordinator- Contract
Clinical Data Coordinator-Contract
Compliance Coordinator-Contract
Information/Clinical Data Entry Coordinator-Contract
