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Safety Physician Resume Example

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SAFETY PHYSICIAN
Professional Summary

•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

Skill Highlights
  • Serious case processing (Phase 1/2 through post marketing surveillance), quality and medical review steps handled in US for global cases
  • Medical evaluation of ICSRs including expectedness, relatedness, coding, queries, narrative review and analysis of similar events
Professional Experience
NovavaxOctober 2013 to CurrentSafety Physician
Gaithersburg , MD

•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

Amita HealthJuly 2009 to February 2014Full time hositalist 2009-2011/Moonlighting hospitalist 2011-2014
Vestal , NY

•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.

Executive Health ResourcesAugust 2012 to September 2013Physician Advisor
City , STATE

•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

Veterans Administration HospitalJuly 2011 to July 2012Associate Director for Hospital Medicine
City , STATE

•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

Penn Presbyterian HospitalJuly 2005 to June 2009Clinical Pharmacology Unit Moonlighter
City , STATE

•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

Thomas Jefferson University HospitalJune 2005 to June 2009Hospitalist/Instructor Internal Medicine
City , STATE

•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

Rush University Medical CenterJuly 2001 to June 2005Hospitalist/Assistant Professor in Internal Medicine
City , STATE

•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

Education and Training
Rush University Medical Center2001Internal MedicineCity, State

Internship, Residency and Chief Residency

Sidney Kimmel Medical College (formerly Jefferson Medical College)1997Doctor of MedicineCity, State
Penn State University1993Bachelor of Arts: General Arts and SciencesCity, State
Licenses

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

Languages

English (fluent), Russian (conversational)

Affiliations

Member, American College of Physicians

Publications

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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Resumes, and other information uploaded or provided by the user, are considered User Content governed by our Terms & Conditions. As such, it is not owned by us, and it is the user who retains ownership over such content.

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Resume Overview

School Attended

  • Rush University Medical Center
  • Sidney Kimmel Medical College (formerly Jefferson Medical College)
  • Penn State University

Job Titles Held:

  • Safety Physician
  • Full time hositalist 2009-2011/Moonlighting hospitalist 2011-2014
  • Physician Advisor
  • Associate Director for Hospital Medicine
  • Clinical Pharmacology Unit Moonlighter
  • Hospitalist/Instructor Internal Medicine
  • Hospitalist/Assistant Professor in Internal Medicine

Degrees

  • Internal Medicine
    Doctor of Medicine
    Bachelor of Arts : General Arts and Sciences

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