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Medical Physician, Clinical Research

Location:
Wellington, FL
Salary:
$125,000
Posted:
September 04, 2014

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Resume:

***** *** **** ***

Wellington, FL *****

561-***-****

Joseph M Pegram, M D MS

Clinical Research – Drug Safety Pharmaceutical Research

(certified)

Medical Case Review and Management Emerging Disease Investigation

OBJECT I VE:

Use my t horough medical knowledge, clinical t raining, p roven leadership abilities,

and team-oriented approach to work in the biopharmaceuticals industry.

CERT I F ICAT IONS ACH I EVED:

• USA and EU Pharmacovigilance Reporting and Pharmacovigilance Auditing;

S ignal Detection

• Basic L ife Support, Advanced Cardiac L ife Support, Pediatric Basic L ife

Support

• Advanced Pediatric Life Support, Emergency Obstetrical Hemorrhage,

• In tubation & MAC Anesthesia Applications.

CAREER H I G H L IG H TS

Centers for Alcohol and D r ug Studies, Lake Worth, Fl

06/2013 to P resent

M edical Case Review Physician \ Medical Monitor and Peer L iaison

• Provide interpretations of clinical results in preparation for review by evaluating clinical data,

scientific literature and publications, analyzing scientific data and stay abreast of current clinical

practice, perform triage on single cases and determine significance. Write expedited reports as

needed for the CRO client base.

• Maintain database of current pharmacological t reatments; anticipate adverse

events with medical and psychiatric physicians making recommendations on

new t reatments according to new protocols and FDA warnings as

appropriate. Reporting for new SAE’s.

• In terface with physicians in small and large group settings for the purposes

of didactic and real time coordination of patient outcomes with special

emphasis on appropriateness of protocol use or exclusion criteria. Provide all

data sets on individual cases and provide them to physician peers.

I nvestigate requirements for patient adherence, protocols, and abuse history

• Monitor patient results; oversee facility protocols for study and t reatment

10752 Oak Bend Way

Wellington, FL 33414

561-***-****

ini tiation, continuation, and final reporting. Assigned as Primary Medical

Monitor for therapeutic areas concentrated on Addiction Specialties,

Psychiatric, and CNS with occasional oversight and evaluation of multi-

disciplinary patients in stage 3 and 4 t reatment protocols for drug-drug

i nteractions and pathological severity assessments.

• Report all new SAE’s on experimental/Phase IV t reatments to participating

t r ial pharmaceutical partner for analysis. Ensure GCP and SOP protocols are

met

• Review PSUR’s on Phase I I I & IV SAE’s and studies in interactions for

AstraZeneca Seroquel, Novartis T r i leptal, and Pfizer E ffexor SR, Reckitt

Benckiser Pharmaceuticals S uboxone SL i n acute & post-acute addiction

patient populations. Report to Chief Medical Officer any atypical findings;

manage aggregate reporting sections in reporting as assigned

• Submit to the FDA AER reporting forms as needed and required based on

patient responses as adverse events and side effect reporting requires;

maintain MedWatch submissions.

• L iaise with investigators, research staff, and remote colleagues to support

clinical data exchange. I ndicate H IPPA requirements for patient privacy; File

a ll reports complying with protocols and appropriate notifications with SAE’s;

p rovide quality control on patient reporting

• Assist Medical and Psychiatric physicians in evaluating t reatment protocols,

review on rounds, create progress notes and evaluate new patients for study

i nclusions.

• Respond to unsolicited inquiries from physicians and other health

p rofessionals on study parameters and outcomes, formulate responses

t ailored to study boundaries, and perform interactive physician-to-physician

review of outcomes and case discussions within assigned therapeutic area

B roward State College, Ft Lauderdale, Fl

12/2012 – 08/2013

A djunct P rofessor Anatomy/Physiology

Lecturer in Anatomy and Physiology/Biology/Pharmacology.

• Provides competency-based education, which aligns with the university model

of curricula as well as supports the College style of system delivery.

• Designs and delivers class instruction th rough the development of

10752 Oak Bend Way

Wellington, FL 33414

561-***-****

instructional plans to meet course competencies, the development of activities

w hich support lesson objectives, and delivers the instruction as approved.

• Enables the achievement of pre-described exit competencies for student

achievement and evaluation of learning by providing instruction, which

fosters competencies and establishes student performance criteria and

evaluation.

• Deliver instruction by establishing a classroom environment conducive to

learning and student involvement as well as effectively planning and

p reparing for classes and student success.

• Managed the learning environment th rough keeping accurate records online,

submit ted grades and other reports, and enforced school/campus academic

and/or attendance policies.

• Contributed to a learning culture by participating on curriculum and system

t ask forces, supporting local campus events such as orientation and

g raduation, and participating in various other workshops and meetings.

• Related professional/life/industry experience to learning by the continuation

of professional/technical skills development, the introduction of industry

perspective into courses, and the active awareness of professional/industry

t rends and opportunities.

Academic-Medical Research Associates, Chicago

09/2009 – 06/2010

Lead Medical Science Writer, Scientific Expe rt (remote contract)

• Write multiple sections of clinical and data reports, assist with evaluation of

reporting

• Research current studies and assess for cross collaboration inclusions,

assigned aggregate sections as needed.

• Assign sections, write, and coordinate integrated clinical study reports for regulatory submission,

research and write manuscripts for publication, edit preclinical and clinical manuscripts.

CL I N ICAL RESEARC H ( 2004 – 2011)

C hiltern Research Ltd. F eb - September

2005

Oncology P r inciple Investigator

" Bi-phenotypic Leukemia in mixed race children" and "Calcium Channel Up-

10752 Oak Bend Way

Wellington, FL 33414

561-***-****

Regulation in Leukemic events: possible causes and t reatment protocol designs"

sponsored by the Medical Research Council of the U.K.- Royal Medical Society,

London & SCCoM Hematology Symposium

• Designed the study parameters, wrote the narrative, and performed cross

l i terature searches for new cross collaborative data and protocols for dual

synergistic oncological method effectiveness. Alternating ALL and AML

t reatment protocols versus stem cell replacement therapy

• Oversight of the conduct of research in accordance with regulations and

sponsoring agency policies and procedures; the research team to help ensure

ethical conduct in all aspects of the research process including but not limi ted

to the t reatment of human subjects, conflicts of interest, data acquisition,

management, sharing and ownership, publication practices, responsible

authorship, and collaborative research and reporting.

• Promotes the ethical conduct of research by reporting good faith suspicions of

m isconduct in research as defined within the Research In tegrity Policy.

• Presented results to peers with corresponding data and analysis and

compliance

• Individual Case Review and acted as scientific advisor.

• Review and complied adverse event data and produced necessary t r ial

reports.

GlenEagles CRC, Ha r tford CT Jan – May 2009

Lead Medical Case Reviewer

“Antibiotic Resistance in 3rd world count ries with free access to OTC antibiotic

medications vs US patient populations.” World Health Organization (SJGH, I.D.

Dept.)

• Evaluated li terature, CDC protocols, current new studies with Phase 1 and 2

data sets from Basilea Pharmaceutical t r ial data and N I H/CDC sponsored

t r ials of new antibiotic regimens

• Create comprehensive narratives procured from relevant, related information

f rom various source materials; Cohort study design with predictive case

s tudies in Asian patients.

• Review of CRF’s and interpretation of results; oversight of outsourced medical

review of seriousness, expectedness/listedness, causality, coding, and

narratives of individual case safety reports for investigational and marketed

10752 Oak Bend Way

Wellington, FL 33414

561-***-****

products

Feuerbach& Assoc. May – Oct 2008

Medical Analyst / Writer

Hemorrhagic Vi rus Potentials in Bio-Warfare (Treatment capacities of Ribavarin

t herapeutics), T eva Pha rmaceuticals LTD I nc ; – w ith SJU Immunology Dept.

Chair

• Wrote all immunological narratives and microbiological predictive genetic

assessments

• Examination of Case Report Forms from infections dealing with hemorrhagic

v iruses and homozygous cell types with Neiman-Pick C1 genotypes.

Accumulated all data for inclusion and examination for publication.

Concent r ics Research June –Nov 2009

Medical Case reviewer

" Emerging Diseases involving t ranscontinental Travel and infectious contagion"

• Designed protocol for evaluation and assessment of epidemiological findings.

• Used CDC data sets for appropriate designs and evaluation of pathology

reporting

• Evaluation of viral etiologies with most effective attack rate and systemic

effectiveness

ClinActis/Dornier Jan –July 2011

U rology – Clinical Device T r ial Monitor

"Stone free rates of patients using the Dornier I I L i thotriptor" cohort t r ial and

s tudy for D ornier MedTech . (OLFU GH); assumed direct interface role with

Dornier for assessment of device efficacy and patient stone-free ratio pre & post

p rocedure.

• Evaluate Data sets, evaluated cases for inclusion, provide patient analysis

and epidemiology, participated in the development of clinical strategy and

t r ial design

• Responsible for the management and integrity of the design, conduct, and

reporting of the research project and for managing, monitoring, and ensuring

t he in tegrity of any collaborative relationships.

10752 Oak Bend Way

Wellington, FL 33414

561-***-****

• Evaluated scientific li terature and publications, followed GCP and ICH

p rotocols for accurate reporting, wrote all narratives along with pathology

evaluation summaries.

• In terpreted clinical study results in preparation for clinical study reports and

regulatory submission, file all forms in conjunction with IRB regulations and

s tudy needs.

• Work done in conjunction with Asian CRO ClinActis th ru the Chief Urologist

i n cooperation with Dornier MedTech Asia L td.

P remiere Research I nc. Jan- April 2011

Asst. P M I

I nfectious Disease Protocol Adherence in ICU and Telemetry patients with contact

isolation inhibitions (Sacred Heart Hospital, Chicago I L L)

• Analysis of acute Staph Infections in post operative patients and the use of

Vancomycin

• Provide Case Reporting to P.I. with Side Effect profile on African American

male patient population emphasis

Northwestern University J uly – Sept 2011

Asst. P M I

Water Borne Attack on Small Community with Dual Diarrhea-causing Agent

( Norwegian American Hospital, Pediatrics Dept, Chicago, I L L)

• Develop protocol for medical evaluation of regional infection.

• Developed methodology of potential attack sites and patient presentations in

ER

• Researched and evaluated CDC mandated clinical strategies

• Developed protocol for alert system in conjunction with L.E. and Federal

Agencies

Clinical / Surgical Additional T raining

• Surgical 1st/2nd assistant - General & Urologic Surgery for hernia, bilateral

b reast reductions, laparotomy procedures, Cesarean Sections, C-scope and

E GD.(Saint Bernard’s Hospital, Chicago)

● Assistant with medical evaluation team for mobile health clinic to t reat H IV, STD,

chronic medical co-morbidities in homeless indigent patients ( Howard Brown Clinic

Mobile Testing Unit, Chicago, I L L)

10752 Oak Bend Way

Wellington, FL 33414

561-***-****

● J r. House Officer ( Inte rn) – Sacred Heart Hospital, Chicago (closed), I.M. Dept.

(2012)

● Responsible for Emergency Dept, ICU, and Telemetry f loor patients

and reporting.

P rofessional Ente rtainment professional A ug 1982 - 2003

● P rimary Instrument – T rumpet/Keyboards/Composition

● B roadway pit orchestra tours – Cats, Pippin, My Fair Lady, Music Man Revival.

● Toured with Ben Vereen, Tony Bennett, Frank Sinatra, and many others

● Sound Design & Music Producer for Universal Studios Fireworks Display.

● B uil t private studio to team with musicians to produce music scores for movies, TV,

and radio commercial project; managed staffing, contracts; contracted for local

agencies, Disney, Navy, Universal Studios, and many private industrial clients.

ACADE M IC QUAL I F ICAT IO NS – Medical Doctorate & Masters in

B iology/Emerging Disease

O ur Lady of Fatima University, College of Medicine Graduated, Valenzuela, Ph

M edical Doctorate

• Obstetrics & Gynecology I & I I,

• Orthopedic Surgery, Urology, Surgical Pathology

• Pediatrics, Infectious Disease, Internal Medicine, Family Medicine

• General Surgery, Neurosurgery, Psychiatry

• Clinical Diagnostics, Family Practice, Anesthesia

• Clinical Research and Pharmaco-therapeutics Uses in Research Applications,

• Radiology, ENT/Ophthalmology

St. Christopher's College of Medicine; London, England

Completion of Basic Sciences

• Human Anatomy, Cell Biology, Physiology, Laboratory Histology, Clinical Psychiatry,

• General Pathology, Systemic Pathology, Neuroscience, Clinical Medicine, Medical

• Pharmacology, Immunology, Medical Microbiology, Radiology I, Embryology, Ethics,

• Medical Genetics, Epidemiology, Physical Diagnosis

• Hematology Paper Presentation/Publication: Royal Medical Society April 2005 –

Biphenotypic Leukaemia in a pediatric patient (AML / A L L).

University of St. Joseph, West Ha rtford, CT

Master of Medical Biology, Emerging Diseases emphasis

• Medical Protistology, Cancer Biology, Advanced Physiology, Cell Biology, Public Health,

• Advanced Pathophysiology, Cell Biology, Neuroscience, Emerging Diseases, Medical

• Pharmacology, Immunology

• Degree conferred

E astman School of Music; Rochester, NY

Master of Music (Performance Certificate)

10752 Oak Bend Way

Wellington, FL 33414

561-***-****

University of M iami, Coral Gables, FL

Bachelor of Music Performance and Composition

M usic Theory, Performance, composition, Contemporary media, Music History



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