Deborah Smith Email & Phone Number

Horsham, Pa

Responsible for triage and processing of serious (15-day) expedited and non-serious adverse event reports for clinical trials (Phase I-IV) and post marketed products from a variety of sources including spontaneous, solicited, literature, pregnancy, and registries. Review the managers daily report to prioritize and ensure compliance within regulatory and partner PVA timeframes. Responsibilities also includes single case unblinding and end of study unblinding within the safety database, SUSAR preparation, deviation memo preparation, SAE/AE reconciliation, and review of protocol update request forms for accuracy prior to entry into safety database. Liaise with Pharmacovigilance Physicians as appropriate to discuss and clarify appropriate information required for case processing. Frequent interaction with LSOs and clinical team representatives to request appropriate information to process cases, resolve discrepancies, and errors involving investigative site SAE form completion. Participated in inspection and audit readiness activities. Assisted with mentoring and supervision of staff as requested. Participated in various departmental project teams. Reviewed weekly and monthly edit check reports to identify processing inconsistencies and errors in labeling of events. Most recently providing vendor oversight for products. Experienced in MedDRA and WHOdrug. Areas of responsibility included Biologics, Cardiovascular, Anti-Infectives, and Oncology. Working within ARISg database

Processed serious and non-serious reports received on investigational and marketed products, including spontaneous and clinical trial reports, literature/scientific publications, line listings from various reporting sources, and pregnancy reports into the ARISg Pharmacovigilance database. Performed telephonic follow-up on serious expedited reports as required.Experienced in the use of MedDRA and WHODrug for processing reports.Areas of responsibility included Neurology, CNS, and Pain.

Collegeville Pa

Performed coding of clinical trial data for Phase I-IV trials using MedDRA and WHOdrug dictionaries. Experienced in WHOART and use of InForm database.Participated in departmental process and policy improvement and assisted in development of standard documentation philosophy guidelines and quality control.Identified and collaborated with other resources in the development of various quality assurance and metric reports for the department.

Staff Nurse ICU/CCU/Telemetry

Bsn, Nursing

Rn Diploma, Nursing