•Over 15 years of academic and clinical experience as an Internal Medicine Physician and Hospitalist
•2.5 years pharmaceutical industry experience in drug safety, with knowledge of FDA and international regulations, MedDRA coding, and safety databases including ARGUS, ARISg and Empirica Trace
•Expertise in medical evaluation of serious adverse event cases from clinical trials in phase I/II, III, and IV and postmarketing sources, including investigational products and devices in the fields of oncology, cardiovascular medicine, endocrinology, neurology, rheumatology, orthopedics and other indications
•Lead safety physician for several investigational product and device studies; responsible for expectedness and causality assessment, expedited case review, query generation, narrative review and composition of analysis of similar events
•Provide physician support to the Drug Information & PV product support (call) center and the related projects in oncology, endocrinology, hematology, and cardiovascular clinical trials, for medicinal products and devices in clinical trial and post-marketing realms, including the review of reported cases and the review and approval of all serious and unlabeled ADR narratives
•Provide recent PSUR similar event review and write an analysis statement on determined relatedness
•Provide PV consultation on safety aspects of IND studies conducted by ICON including: SAE reporting to sponsors and regulatory authorities, communication of safety issues, as necessary under the direction of the Sr. Director Drug Safety
•Responsible for the accurate assessment of S/ADRs, particularly the event's seriousness, labeling and appropriate coding within MedDRA for standalone safety projects; for clinical projects lacking an ICON medical monitor, the safety physician provides input on other safety issues that may occur during the course of the project and may provide consultation to those project teams on project related safety issues
•Participant in bid defense
•Perform literature reviews as required
•Assist sponsors with formulation of responses to regulatory inquiries as required
•Co-author of evaluation of safety signal detection section of employee manual
•Participate in client meetings, project related training sessions and workshops, working closely with drug safety associates, medical monitors, project managers and sponsors to achieve a high level of client satisfaction
•Hospitalist working a combination of day and night shifts, including coverage of general medical units, telemetry and a critical care unit in a rural hospital with limited medical resources.
•Revised hospital venous thromboembolism prophylaxis guidelines based on updated ACCP recommendations.
•Medical consultant for Obstetrics-Gynecology and renowned Orthopedics group.
•Member of the Infection Control Committee and a member of the Credentialing Committee.
•Conducted written reviews per specialized appeals processes as defined by commercial payors
•Provided appeals arguments for inappropriately denied or downgraded medical necessity determinations made by health care organizations
•Promoted payor and client adherence to all applicable accreditation standards
•Conducted real-time verbal and written reviews of currently hospitalized patients, with the goal of ensuring compliance with guidelines put forth for Medicare and Medicaid services. Directly contacted treating physicians to educate them in improving documentation to support ordered levels of service
•Full time hospitalist working a combination of day and night shifts
•Participated in the design and integration of a new hospitalist program with goals of improving patient flow, decreasing length of stay, and coordinating appropriate follow-up with outpatient physicians
•Served as Internal Medicine consultant for other specialty and subspecialty services
•Responsible for physical examinations, electrocardiogram interpretation, telemetry monitoring, and overnight hemodynamic and clinical monitoring of safety variables in Phase I clinical trials
•Reviewed compliance standards, good clinical practice guidelines and standard operating procedures appropriate to the position
•Served as director of Hospital Medicine at the Jefferson Hospital of the Neurosciences
•Responsible for perioperative evaluation and co-management of neurosurgical patients including neurovascular, tumor, stroke and spine pathology
•Teaching attending for General Internal Medicine consultation service and Jefferson Anti-Thrombotic service
•Faculty for didactic curriculum for third year medical students
•Staff attending physician for acute care office visits in the resident and attending continuity clinics and Teaching attending for the inpatient ward service
•Established and developed a hospitalist program for Rush University Internists Primary Care Group and unassigned patients requiring hospital admission
•Teaching attending for inpatient resident staffed ward service
•Primary staff medicine coverage of open Cardiac and Medical Intensive Care Units.
•Faculty for first and second year medical student curriculum
Internship, Residency and Chief Residency
Board certified in Internal Medicine, ABIM 2000
Board recertified in Internal Medicine, ABIM 2010
Certification in Fundamental Critical Care Support from SCM 2010
Licensed Physician and Surgeon, State of PA 2005 to present
Licensed Physician and Surgeon, State of CO, 2009 to 2015
English (fluent), Russian (conversational)
Member, American College of Physicians
Book Chapter. The patient with substance abuse going to surgery. Medical Management of the Surgical Patient. 3rd ed. Merli G, Weitz H (ed.) Saunders/Elsevier Philadelphia 2008. Pages 495-533
Poster presentation for Society of Hospital Medicine: Medical Co-Management of Neurosurgical Patients
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