Quality Assurance Data
Resume:
NATHALIE HAWSE
Millville, NJ 08332
******@*****.***
SUMMARY
Highly motivated drug safety and quality assurance coordinator with experience in the pharmaceutical industry. Specific expertise with managing drug safety databases and ensuring consistency with the global adverse event database. Strong communication skills and an ability to operate in a fast paced environment. Consistently recognized for accuracy and timeliness of work.
EDUCATION
BS, Nursing, The University of Medicine and Dentistry of New Jersey, Newark, NJ, Degree expected December 2011
BS, Public Health, Business minor, The Richard Stockton College of New Jersey, Pomona, NJ, 2007
FUNCTIONAL SKILLS
Drug Safety Data Entry eLibrary Management
Knowledge of cGMP requirements QA Document Preparation
Investigator Report Distribution Experience with SAP, MedDra and ARISg
PROFESSIONAL EXPERIENCE
IMCLONE SYSTEMS INCORPORATED 2007 – 2010
Drug Safety Coordinator, Bridgewater, NJ 2009 – 2010
Coordinated data management activities including completing the entry of initial and follow-up information from SAE form or CIOMS via fax or email, maintaining tracking sheets and ensuring consistency with the electronic database, and assisting in the entry of back logged cases.
-Met reporting requirements by using MedDra terms in case entry while maintaining consistency with the global adverse event database (ARISg).
-Ensured data accuracy by performing data consistency checks within the global adverse event database and CRO.
-Helped meet tight project schedules by distributing reports to investigators and the FDA within required timeline.
Quality Assurance Documentation Coordinator, Somerville, NJ 2007 – 2009
Prepared and routed document packages throughout the review and approval cycle. Wrote and updated departmental Standard Operating Procedures as needed.
-Ensured on-line e-library was updated and accurate by tracking document approval activities in an electronic tracking system and entering data as needed.
-Distribute approved documentation to appropriate personnel, track receipt of documentation, and maintain distribution matrices.
-Ensured documents were reviewed and revised to reflect current procedure or made obsolete, if needed, by initiating and tracking Periodic Document review.
-Met documentation requirements by issuing controlled Production Documentation to Manufacturing and Laboratory Notebooks to cross functional areas and maintaining records of issuance.
-Kept cGMP skills up to date by attending training programs as required.
SHORE MEMORIAL HOSPITAL, Somers Point, NJ 2007
Patient Registrar
Maintained confidential files and records ensuring accuracy and completeness. Reviewed patient's medical record, abstracts and coded information (demographic characteristics, diagnostic procedures and treatment), and entered data into computer.
-Ensured data was readily available for physicians and research studies by compiling and maintaining records.
-Collected information from incoming patients regarding services needed, insurance available and financial status.
COMPUTER SKILLS
Experience with Microsoft Word, Excel, Outlook, PowerPoint, Lotus Notes, Access, Publisher, ArisG, File Tracker, Trackwise, SAP, MedDRA and Pilgrim
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