Scott P. Varga

Glenside Pennsylvania *****

610-***-****

Education:

Villanova University, Villanova, PA

BSN, RN, 2004

Technical Skills :

Oracle Clinical, EDC, RDC, TMS, RAVE, ARISg, ClinPlus, ClinTrial, Lifetree. Coding (MedDRA,

WhoDrug, WhoDrug Hybrid. Microsoft Outlook and PowerPoint.

Work Experience:

i3 (for Genentech), Glenside, PA

Clinical Coding Specialist (Contract), May 2010-October 2010

• Expert ability to code clinical trial data using MedDRA and Drug Dictionaries and TMS (Oracle Clinical) coding system.

• Efficiently trained clinical coding for system being used by sponsor.

• Assist in developing clinical coding conventions.

Premier Research Group Limited, Philadelphia, PA

Safety and Coding Specialist, June 2008-April 2010

• Primarily focuses on ensuring the clinical integrity of the database.

• Reviews CRFs, data listings, and database to ensure that captured data follow the rules outlined by the protocol and data management plan.

• Completes coding or performs quality control on the coding of adverse events, medications, physical examination, and medical history data as defined in the data management plan for each study.

• Performs SAE Reconciliation.

• Generates paper and electronic queries to appropriate internal or external personnel to resolve problematic data identified during various aspects of the data management process.

• Reviews responses to queries for appropriateness and resolves any discrepancies.

• Reviews draft protocols and CRFs for potential data collection and representation, database structure or data entry problems, and provides feedback to the project team, when requested.

• Assists in creating, reviewing, and processing Data Clarification Forms and updating the databases.

• Assists in writing, updating and/or reviewing of data management plans, coding guidelines, CRF completion guidelines, data entry guidelines, data management reports, and other documents required for preparing and completing databases, when requested.

• Assists in receiving and processing SAEs for initial vs follow up report.

• Tracked SAEs in ARISg.

• Prepare draft CIOMS/ MedWatch forms.

• Writes draft responses to ad hoc safety queries.

• Writes draft Periodic Safety Update Reports (PSURs), expert reports, and justification documents.

• Contributes to expert reviews and the development of risk management plans, and other documents or assignments as required.

• Ensures documents are scientifically accurate, and meet company and regulatory standards

• Assists the manager in the day-to-day surveillance activities of assigned products, pertinent safety issues and provision of safety reports within the specific therapeutic area.

• Receives input from all other Pharmacovigilance personnel, senior management, other internal organizations and affiliates, external healthcare professionals, and regulatory agencies.

• Assists in writing narratives and formatted narratives according to SOP.

• All other projects as assigned.

Merck and Co., Inc., Blue Bell, PA

Medical Report Coordinator (Contract), September 2007-January 2008

• Medical Report Coordinator in Product Safety reviewing records for medical conditions pertinent for adverse events in litigation.

• Solid understanding of Good Clinical Practices and FDA guidelines.

• Obtain Legal Clarification when necessary upon receipt of plaintiff data.

• Ability to work on multiple projects simultaneously.

• Review information received, identify relevant information pertaining to adverse experiences, and determine report ability to worldwide regulatory agencies for adverse experience (AE) reports from clinical study and post-marketing environments.

• Computer efficient in Word, Excel and Power Point.

• Consistently exceeds productivity and benchmark guidelines.

Mercy Suburban Hospital, East Norriton, PA

Registered Nurse, Cardio-Thoracic ICU & ER (Contract), November 2006-December 2007

• Implemented scope of practice as RN

• ACLS certified

Centocor Inc., Horsham, PA

Medical Communications Associate (Contract), May 2007 – September 2007

• Support innovative products on major disease areas; cardiovascular, immunological disorders and cancer.

• Immunological disorders involvement in therapeutic areas consisted of Dermatology, Rheumatoid, Pulmonary and Gastro-intestinal

• Extract adverse event information as well as addressing required follow-up information for adverse events: Therapeutic areas with Dermatology, Rheumatoid, Pulmonary and Gastro-Intestinal and Phase III trials.

• Support innovative products on the management of three major disease areas; cardiovascular, immunological disorders and cancer.

• Execute a proactive safety communication plan to reinforce the benefit: risk profile for Dermatology, Rheumatoid, Pulmonary, Cardiovascular and Gastro-Intestinal and Phase III trials.

• Support all information regarding adverse events, risk management and product complaints.

• Perform Quality Assurance review of SAE reports.

• Prepare scientific materials to support the roll out of new indication launches.

• Post-marketing studies, including phase IV and investigator initiated studies, as well as registries

• Support Medical Affairs, including DOME, internal physicians, and clinical scientists – Medical Science Liaisons (CS-MSL) through data support, presentations.

• Bridge Clinical Data with Strategic Initiatives.

Sunoco Oil Refinery, Philadelphia, PA

Clinical Research Nurse (Contract), November 2006 – May 2007

• Development of study specific documentation.

• Monitoring of the study.

• Recruitment tracking and supervision of study sites.

• Training of study personnel at investigator’s sites.

• Coordinating the approval process for the performance of clinical studies.

• Tracking and assurance of data quality at the site.

• Site documentation at the investigator and in-house.

• Organization and performance of investigator meetings.

• Assisting with the site selection process.

• Compile study-relevant documents including Case Report Forms (CRFs)

• Plan and perform co-monitoring, and write co-monitoring report

• Decide whether any issues have occurred and provide feedback

Chestnut Hill Hospital, Philadelphia, PA

Registered Nurse, Emergency Room & Cardiac, September 2005-November 2006

• Implemented scope of practice as registered nurse

• ACLS certified

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