Data Safety

DAT NGUYEN

*** **** ******* *****, *** Jose, CA *5123 Cellular: 408-***-**** Email: **********@*******.***

PROFESSIONAL PROFILE

Experience in and familiarity with document control projects, and quality assurance/compliance programs.

Experience in collecting, reviewing, processing, and archiving documents in accordance with document control procedures and policies.

Experience in coordinating large number of document files, in converting and uploading documents onto electronic document management systems.

Experience with Case Report Form documentation.

Experience with Clinical Studies setup, Clinical Study reports and documentation.

Familiarity with the FDA Regulations, the FDA Drug Approval process, the Drug Safety practice, the Good Clinical Practice, the Clinical Trial practice, and the Trial Master Files..

Working knowledge of MedDRA and WHO Drug coding dictionaries, the Standard Operating Procedures, the Guidelines, and the Data Entry Conventions.

Working knowledge of medical, scientific, and clinical research terminology

Strong project management, factual/data analytical, communication, and organizational skills.

Experience in performing multitasks and project-oriented tasks with special attention to details.

Experience in providing creative problem-solving solutions, in decision-making, and in following-up.

Experience in performing due diligence, in data analysis, and in doing factual/legal/medical/internet research.

Experience in working with and managing different document databases.

Experience in using Excel to create reports, to format reports, and to run reports.

Fully trained on Windows OS, Apple Mac OS, MS Office Suite (Word, Excel, Access, Outlook), Google Apps for Work (Google Docs, Google Sheets, Gmail), Salesforce, Oracle, Adobe Acrobat, FileMaker Pro, Argus Safety, ARISg, ARIS (agXchange), dsNavigator, DataFax, Summations, Lexis/Westlaw, Internet browsers.

Ability to network, to negotiate, and to provide services to internal and external groups of customers.

PROFESSIONAL EXPERIENCE

Work experiences consist of both full-time and multiple contractual positions at the following:

STANFORD UNIVERSITY BOOKSTORE, Palo Alto, CA Sep 14 – Aug 15

Temporary Sales Associate

Greet and assist customers in giving options and advice on customers’ needs.

Inspire customers to buy the merchandise items, and close the purchases.

Use the Point-of-Sales systems to conduct and close the transactions.

Maintain selling floor presentations, and restock items as needed.

Clear and recover the merchandise items. Return the items to the proper area of the selling floor.

Learn the Stanford Bookstore’s systems and procedures to enhance selling efficiencies and complete support duties.

NEKTAR THERAPEUTICS, San Francisco, CA (thru Talent Logic, Inc.) Jul 13 – Dec 13

Drug Safety Specialist

Provided short-term contractual assistance to the Drug Safety department.

Booked and processed the case safety reports from clinical trials, including initial and follow-up reports.

Data-entered the information from the case safety reports onto the ARISg Safety database.

Coded Adverse Events and Medications.

Reviewed the case safety reports for missing data, inconsistencies, or errors.

Created and ran weekly metrics and line listing reports.

Reviewed the case files and document email notifications, queries, and case report forms for compliance reason.

GENENTECH, INC., South San Francisco, CA (thru Yoh Staffing) Feb 12 – Oct 12

Drug Safety Associate I

Provided contractual assistance to the Access Solutions Organization and the Patient Resources Center on the Adverse Event project.

Researched and reviewed the patient information from the Case Management System database for the Adverse Events.

Performed data entry of all Adverse Events cases onto the agXchange database application suite of the ARIS database.

Wrote the event summary narratives of the Adverse Event cases in the agXchange database application suite of the ARIS database.

Searched the Patient Records for the reportable outcomes and adverse events to be submitted to the Drug Safety Department for further investigations.

MACY’S WESTFIELD VALLEY FAIR, San Jose, CA Nov 11 – Jan 12

Holiday Retail Sales Associate

Greeted and assisted customers in giving options and advice on customers’ needs.

Inspired customers to buy the merchandise items, and closed the purchases.

Used the Point-of-Sales systems to conduct and close the transactions.

Maintained selling floor presentations, and restocked items as needed.

Cleared, and recovered the merchandise items. Returned the items to the proper area of the selling floor.

Ensured that fitting rooms are ready for uses by customers.

Learned the Macy’s systems and procedures to enhance selling efficiencies and complete support duties.

ACTELION PHARMACEUTICALS US INC., South San Francisco, CA (Self-Contracted) Aug 09 – Oct 09

Drug Safety Coordinator

Provided short-term contractual assistance to the Drug Safety department.

Booked and processed the case safety reports from clinical trials and post-marketing reports, including initial and follow-up reports.

Triaged cases by reporting criteria, and assigned case processing priority.

Data-entered the information from the case safety reports onto the Argus Safety database.

Coded Adverse Events and Medications.

Reviewed the case safety reports for missing data, inconsistencies, or errors.

Identified data requiring further follow-up.

Created and emailed notifications of case safety reports to external co-marketing partners as required.

GILEAD SCIENCES INC., Foster City, CA Aug 2007 – Mar 09

Drug Safety Specialist

Coded and data entered Adverse Events and Medications for clinical and post-marketing safety data in ARISg and dsNavigator databases using the MedDRA and WHO Drug dictionaries.

Performed quality control checks on coded data in the Mapping and Synonym tables.

Reviewed the Adverse Events and Medication coding data for inconsistencies or errors.

Participated in the biannual updating process of the MedDRA dictionary in the Drug Safety databases.

Generated data listings of terms for analysis of similar events.

Data-entered highly confidential information.

Supported the Adverse Event Management group in coding Adverse Events and Medications.

Participated in the SOP process by drafting, reviewing, and editing the Standard Operating Procedures (SOPs).

Developed and maintained a metrics framework for tracking the coding activities.

CV THERAPEUTICS, Palo Alto, California (thru Advance Clinical) Oct 05 – May 07

Drug Safety Assistant

Booked and processed the case safety reports from clinical trials and post-marketing reports.

Data-entered the information from the case safety reports onto the Argus Safety database.

Reviewed and validated the case safety reports for missing data, or errors.

Identified data requiring further follow-ups.

Drafted narratives using the standards narrative templates.

Reviewed the case safety reports and edited the narratives written on the Argus Safety database.

Reconciled the data between the case safety reports and the Argus Safety database.

ALZA CORPORATION, Mountain View, CA (thru Kelly Services) Jul 03 – Jul 05

Clinical Data Validation Specialist

Reviewed, validated, and audited clinical data from various drug and pharmacokinetic studies of the Company’s pharmaceutical products in preparation for the FDA’s Review and Approval process.

Created and resolved the queries on questionable clinical data.

Reviewed the Case Report Forms to validate the clinical data entered on the databases.

LUMENIS CORPORATION, Santa Clara, CA (thru Robert Half Legal) Mar 02 – Oct 02

Paralegal

Provided contractual assistance on a project involving the Securities Exchange Commission's accounting inquiry.

Reviewed and analyzed documents relating to the practice of revenue recognition by the Company, its US and international distributors in response to the Securities Exchange Commission's discovery requests.

Coordinated with the Company's outside counsel, Skadden, Arps, Slate, Meagher & Flom LLP, for the production of documents to the SEC.

LYON & LYON LLP, San Jose, CA (thru Special Counsel, Inc.) Jan 01 – Nov 01

Paralegal

Provided contractual assistance to the attorneys on a patent infringement lawsuit.

Prepared, reviewed, and organized documents for several document productions in response to the discovery requests. Prepared exhibits for witness depositions.

Input, maintained, and updated internal databases of documents.

SPECIAL COUNSEL PROFESSIONALS, INC. Palo Alto, CA May 00 – Jan 01

Paralegal

Provided contractual litigation assistance at Wilson Sonsini Goodrich & Rosati LLP and at Heller Ehrman White & McAuliffe LLP on individual projects involving document productions, factual researches, deposition preparations, and input of information from factual and legal documents onto databases.

ALZA CORPORATION, Mountain View, CA (thru Kelly Services) Aug 98 – Jan 00

Data Assistant

Provided contractual assistance to the Quality Assurance Stability Group.

Reviewed, audited, validated and input laboratory testing data from the stability studies performed on the Company’s pharmaceutical products and lots.

Maintained and updated internal databases on lot release testing and stability data.

GERON CORPORATION, Menlo Park, CA (thru Adecco) May 98 – Sept 98

Legal Assistant

Prepared, verified, analyzed and reviewed different contractual agreements such as the Confidential Disclosure Agreements, the Material Transfer Agreements, etc…

Organized and maintained contract files.

Created and updated internal databases on Contracts/Agreements, Publications, and Laboratory Notebooks.

Organized and reviewed prior art publications.

PLM INTERNATIONAL, San Francisco, CA (Self-Contracted) Apr 97 – Aug 97

Paralegal

Provided contractual assistance on a security litigation discovery project involving the equipment-leasing corporation and its equipment-leasing investment partnerships

Reviewed, and analyzed documents for factual issues in response to discovery requests.

Coordinated and facilitated the transfer of information between the company and its outside legal counsel.

Performed due diligence tasks and miscellaneous tasks as required by the Company’s attorneys.

HAMBRECHT & QUIST, San Francisco, CA (thru Innovations PSI) May 96 – Aug 96

Human Resources Assistant

Provided contractual assistance to the Human Resources and the Legal Departments

Performed due diligence tasks related to the Firm’s Stock Option and Purchasing Plans in preparation for its capital restructuring and initial public offering.

Prepared and processed stock option grants and purchases for the Firm’s employees.

Audited employees’ stock files and limited partnership files.

Researched the Firm’s and its subsidiaries’ status of corporation filed with individual states.

COOLEY GODWARD CASTRO HUDDLESON & TATUM, Palo Alto, CA Aug 89 – Feb 96

Litigation Case Assistant - Technology Litigation Group

Performed document productions in different litigation cases by collecting, analyzing, and organizing documents.

Assisted in depositions and deposition preparations by reviewing documents and creating key witness and issue binders.

Assisted in substantive case preparation by analyzing internal corporate memorandum and contracts in light of disputed legal and factual issues.

Assisted at trials by identifying and preparing documents and exhibits to be used in direct and cross-examinations of witnesses.

Organized, compiled, and analyzed patent prosecution history files. Organized and analyzed prior art publications. Assisted in case-in-chief preparation in patent interference proceedings by assisting in preparation of declarations, exhibits and final briefings.

Assisted in data analysis in market injury litigation by creating and editing spreadsheets and tracking charts, and analyzing market share statistics.

COOLEY GODWARD CASTRO HUDDLESON & TATUM, Palo Alto, CA Feb 88 – Jul 89

Corporate Case Assistant

Performed due diligence in preparing and drafting annual audit letters.

Assisted in the review of corporate records.

Researched information regarding public companies.

Organized and compiled transaction books for various public and private offerings, venture fund formations, mergers and acquisitions.

Prepared, compiled and maintained stock books, shareholder and corporate records.

PILLSBURY MADISON & SUTRO, San Francisco, CA Aug 86 – Feb 88

Litigation Case Clerk

Assisted in document productions by collecting, analyzing and organizing documents.

Assisted in deposition preparations by creating witness and issue binders, and by preparing deposition exhibits.

Entered, maintained and updated internal databases of documents.

EDUCATION

Bachelor of Arts in Political Science, University of California, Berkeley, CA

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