safety administrator ii contract resume example with 6+ years of experience

Jessica Claire
Montgomery Street, San Francisco, CA 94105 (555) 432-1000,
Career Overview

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

Professional Experience
01/2015 to 06/2015 Safety Administrator II-Contract PPD | City, STATE,
  • 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.
09/2013 to 01/2014 Data Entry Specialist-Temporary Zucker, Goldberg & Ackerman | City, STATE,
  • Process and Data Enter of checks from homeowners seeking renewal on their home loans.
  • Process forclosures and maintain excel spreadsheets on procedures.
10/2012 to 02/2013 Registration Representative-Contract Celgene | City, STATE,
  • 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).
2011 to 2012 Data Entry/Customer Service Representative-Temporary Verizon/Solix Inc | City, STATE,
  • Input data from email sales of cellular phones.
  • Troubleshoot , find solutions to email inquires.
  • Data entry customer information.
  • Answer inquires via inbound calls.
08/2009 to 11/2009 Drug Safety Specialist-Contract Bracco Diagnostics | City, STATE,
  • 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.
09/2008 to 02/2009 SAE Specialist-Contract Wyeth | City, STATE,
  • 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.
09/2006 to 11/2008 Data Steward-Contract Hoffman La Roche | City, STATE,
  • 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 .
02/2006 to 05/2006 Safety Data Coordinator- Contract Berlex | City, STATE,
  • 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.
08/2005 to 09/2005 Clinical Data Coordinator-Contract CMed | City, STATE,
  • 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.
08/2004 to 05/2005 Compliance Coordinator-Contract Pfizer | City, STATE,
  • 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.
04/2003 to 04/2004 Information/Clinical Data Entry Coordinator-Contract Schering-Plough/Berlex | City, STATE,
  • 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.
Expected in 5/1995 to to Certification in Word Processing | BOS/Word Processing Newark Business Training Institute, Caldwell, NJ GPA:
Expected in 1989 to to | Psychology Caldwell College, Caldwell, NJ GPA:


Expected in 6/1987 to to High School Diploma | Drama/College Prep Arts High School, Caldwell, NJ GPA:

administrative, administrative support, clinical research, Clintrial 4.3, copying, client, Data Entry, data processing, database, documentation, e-mail, email, faxes, fax, fax machine, filing, Forms, frame, GCP, letters, Manages logistics, Director, meetings, excel spreadsheets, Excel, office, Windows, Word, PDF, problem solving, processes, coding, proofing, quality, quality assurance, Quality Control, Reporting, Safety, sales, Siebel, Siebel 7, SOP, phones, Troubleshoot, typing, validation, wise, Word Processing, workflow

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Resume Overview

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


  • Certification in Word Processing
  • High School Diploma

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