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Click here or scroll down to respond to this candidateCandidate's Name
Street Address Ford AvenueFords, New JerseyCell PHONE NUMBER AVAILABLEEMAIL AVAILABLEOBJECTIVE: To pursue a challenging position in the pharmaceutical industry that will afford me the opportunity for professional growth and advancement.EDUCATION: 2010 Thomas Edison University Trenton, NJPursuant of B.S. in Psychology2006 Middlesex County College Edison, NJA.S. in Biology2001-2002 Healthcare Training Institute Union, NJEKG/Phlebotomy [Certificate Program]EXPERIENCE:Daiichi Sankyo Pharma Development April 2011 - Present Edison, NJDrug Safety CoordinatorAssist in timely receipt and book-in of clinical and spontaneous SAEs. This includes monitoring the CSPV e-mailbox (and providing backup as needed for the CSPV-Clinical e-mailbox as well as the incoming CRO cases) for incoming cases, booking cases into ARIS, checking for duplicates, and creating and / or locating case files.Perform SAE reconciliation for safety data exchanged among the license partners.Perform monthly post marketing search of ARISg database for medical affairs for all DSPD marketed products.Post clinical line listings to the clinical database (CDR), including converting Excel files to SAS.Participate in safety database validation activities, which may include dry running test scripts, providing feedback on test scripts and database findings, and performing formal validation in accordance with Good Documentation Practices.Send follow-up letters for initial and subsequent cases.Develop case folders and forward to drug safety specialist for review.Create and run NDA PADERS.Perform Validation tasks for database change controls.Subject matter expert for ARISg/ARGUS database.Assist with projects upon request corrections, deletions.Medarex, Inc. - August 2008 January 2010 Bloomsbury, NJDrug Safety Associate (Contracted through Joule)Perform clinical data entry into the electronic serious Adverse Event Reporting System. (AERS) for Serious Adverse Events (SAEs) received to ensure legibility, completeness and accuracy of data.Will assist with requests for case documents, track cases and download E2B transmission information on SAE cases that have been reported during clinical trials. Experience with medical records and other source documents.Assist in the preparation and tabulation of data necessary for completion of reports, both internal and external use as needed.Assist in other tasks as needed. Prepared reporter narratives from source documents.Novartis Pharmaceuticals- August 2007 August 2008 East Hanover, NJDrug Safety CoordinatorReceive, triage and process case reports from post-marketed and investigational drug products.Perform clinical data entry of preliminary and follow-up cases received into the AE database.Search the database to identify patient profiles and prevent duplicate entries.Review cases to ensure legibility, completeness and accuracy of case reports.Send follow-up letters for initial and subsequent cases.Develop case folders and forward to drug safety specialist for review..CMed Inc- July 2005 July 2007 New Providence, NJClinical Data Associate IIReceive, track and scan all patient case books received in-house.Ensure data entry of CRFs into the clinical trial database.Perform QC checks on the entered data to ensure accuracy.Identify errors or inconsistencies raised via manual review and listing review.Generate, track and resolve queries.Maintain accurate documentation and filing systems to ensure safe storage of data.SKILLS/TECHNOLOGIES:I am a motivated team player that excels when challenged and adapts easily to diverse situations. I have the ability to multi-task and adapt to changing priorities and needs. I work well under pressure and am able to meet timelines. I work effectively as a member of a team or independently. I have excellent oral/written communication skills and strong organization skills.Proficient in Microsoft Office Software (Word, Excel, Outlook)Medical TerminologyClintrialARISgARGUSAERSICD-9 / CPT 4 CodingAS400 SystemHIPAA ComplianceExceed 3.6 /3.7GCP |
