∑ Performed coding and consistency review of all studies performed both domestically and internationally.
∑ Served as primary contact for study and project teams concerning data coding issues.
∑ Insure coding accuracy and completeness to meet submission timelines and compliance with standard guidelines.
∑ Facilitated and participated coding reconciliation of data management SAEs on CRF with that of pharmacovigilance.
∑ Established and maintained working relationships with project team members -- pharmacovigilance, biostatistics, clinical data managers, project leaders.
∑ Member of Sanofi-Aventis Quality Document Review Committee for review and update of all data management related SOPs and guidelines.

∑ Performed coding and consistency review of all studies performed both domestically and internationally.
∑ Insure coding accuracy and completeness to meet submission timelines and compliance with standard guidelines.

∑ Responsible for the researching and coding of all adverse events, medical history and drug therapies for clinical trial data across various therapeutic areas.
∑ Extensive experience with utilization of ICD-9,COSTART, MedDRA and WHODRUG coding conventions/thesauri.
∑ Generation of queries to insure accurate data collection for product safety profile.
∑ Established and maintained collaborative working relationships with sponsors, clinical research monitors and investigator sites for clinical data clarification/issues.
∑ Developed and implemented sponsor specific dictionary coding conventions.
∑ Responsible for the validation, maintenance and enhancement of coding dictionaries for project specific requirements.
∑ Reviewed case report forms for data integrity and consistency with generation and resolution of queries to investigator sites.
∑ Provided support as Serious Adverse Event Coordinator in collecting safety data for processing and tracking of serious adverse event reports.
∑ Reconciliation of serious adverse events reported to safety department with that of the data management case report form resolving discrepancies.
∑ Familiarity and working knowledge of ICH, GCP and FDA clinical research guidelines.

∑ Responsible for the researching and coding of all adverse events, medical history and drug therapies for clinical trial data across various therapeutic areas.
∑ Extensive experience with utilization of ICD-9,COSTART, MedDRA and WHODRUG coding conventions/thesauri.
∑ Generation of queries to insure accurate data collection for product safety profile.
∑ Established and maintained collaborative working relationships with sponsors, clinical research monitors and investigator sites for clinical data clarification/issues.
∑ Developed and implemented sponsor specific dictionary coding conventions.
∑ Responsible for the validation, maintenance and enhancement of coding dictionaries for project specific requirements.
∑ Reviewed case report forms for data integrity and consistency with generation and resolution of queries to investigator sites.
∑ Provided support as Serious Adverse Event Coordinator in collecting safety data for processing and tracking of serious adverse event reports.
∑ Reconciliation of serious adverse events reported to safety department with that of the data management case report form resolving discrepancies.
∑ Familiarity and working knowledge of ICH, GCP and FDA clinical research guidelines.

∑ Responsible for researching and coding of adverse event for post-marketed and clinical drugs.
∑ Reviewed and assisted in preparation of FDA periodic reports for post-marketed products.
∑ Project lead for reconciliation of legacy safety data transition coding from WHOART to MedDRA.
∑ Extensive collaboration with domestic and foreign safety coordinators to provide accurate data collection for coding purposes.
∑ Utilized MedDRA, WHOART, ICD-9 and WHODRUG coding thesauri.
∑ Developed and provided interdepartmental training sessions on adverse event coding.

∑ Responsible for processing serious and non-serious adverse events for clinical and post-marketed products from both domestic and foreign reporting sources.
∑ Reviewed product labeling and triaged safety reports for seriousness and expectedness in processing MedWatch reports.
∑ Insure adequate data collection to maintain accurate product safety profile for medical and scientific analysis.
∑ Classified and coded data from foreign affiliates, health professionals and consumers into regulatory reports.
∑ Summarized and assessed clinical information for formulation of narrative summaries on FDA MedWatch report submission.

∑ Responsible for coding of clinical data (medical history, adverse events, and concomitant medications) from various reporting sources utilizing ICD-9, WHOART and WHODRUG coding thesauri.
∑ Participated in clinical team activities relative to study protocol review, clinical report form design and statistical analysis.
∑ Extensive research and analysis of international pharmaceutical products.
∑ Recipient of Impact Award 1999.

∑ Provided direct care to a variety of patients presenting with diverse medical, surgical, obstetrical, pediatric problems and emergencies utilizing extensive assessment and emergency treatment skills.

∑ Supervised 11 professionals providing case management and social work services to Medicaid patients.
∑ Responsible for daily department operations including staffing, evaluations, continuing education and case management services.
. Collaborated with various health care personnel to provide quality medical care in alternative settings such as skilled nursing facilities, rehabilitation, home health, etc.
. Developed and implemented various policies and procedures relative to case management services.

∑ Provided case management services pertaining to home health, physical/occupation therapies and durable medical equipment procurement.
∑ Collaborated with various health care personnel to provide quality medical care in an alternative setting in lieu of acute care.

. Performed admission and concurrent review on adult medical patients utilizing Interqual, M&R, Medicare, and Medicaid criteria.
. Responsible for communicating with various insurance companies to provide relevant medical information relating to membersí hospitalization.
. Determined the most appropriate diagnosis/DRG to optimize hospital reimbursement.
. Assessed patient benefits, medical needs, community and family recources to develop and implement appropriate discharge planning.
. Participated in a muli-disciplinary approach to provide quality medical care with a patient advocate focus.