Hilda Wiryawan Curriculum Vitae Page *

Objective:

Obtain a Clinical Safety Scientist/Pharmacovigilance position at a pharmaceutical company where I

can utilize my clinical and research skills in combination with my educational background in

medicine, public health, and biomedical sciences to improve human health.

Summary of Qualifications

• Biomedical Science PhD candidate with more than five years of experience in clinical and translational

research

• Extensive experience in patient care clinical experience and translational research in drug discovery and

development, compounds mechanism of action characterization, literature review, and scientific writing

• Extensive knowledge of premarketing and postmarketing drug safety and pharmacovigilance; risk

management and safety communication strategies; US and EU pharmacovigilance regulatory

requirements

• Experience in coordinating clinical research project and organizing and presenting medical and scientific

data

Education:

University of California, Riverside, CA

PhD - Doctor of Philosophy in Biomedical Sciences (expected Jun 2014)

Dissertation title: “Characterization of a Small Molecule Compound Inhibitor of SUMOylation

Pathway as a New Approach to Cancer Treatment”

University of California, Los Angeles, CA

MPH - Master of Public Health in Healthcare Policy and Management, Jun 2009

Global Health Certificate

University of Indonesia, Jakarta, Indonesia

B.S., Medical Sciences, Aug 2000

MD - Aug 2002

Knowledge, Skills, and Abilities

• Good Clinical Practice • Suspected Unexpected Serious • EU Risk Management Plan,

Adverse Reactions (SUSAR) REMS

• Good Pharmacovigilance

• Individual Case Safety Report • Drug label, SmPC

Practice

• Drug safety in Clinical Trials • Safety data analysis methods • Literature review, Safety

databases

• FDA (US) &EMA (EU) • DSUR PSUR PBRER PADER

• Polypharmacy & medication

regulations

• Signal detection and evaluation

errors

• ICH Guidelines

• MedDRA and drug names

• Pharmacoepidemiology

• Serious Adverse Events Reports coding

Certification:

Clinical Safety and Pharmacovigilance Certificate from the DIA (Drug Information Association), June

2014

Educational Commission for Foreign Medical Graduate Certificate, Oct 2008 (USMLE Steps I, II, III

passed)

Relevant Courses

• Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum

• Risk Management and Safety Communication Strategies

Hilda Wiryawan Curriculum Vitae Page 2

• Pharmacology, pharmacy, physiology, pathology anatomy, clinical pathology, microbiology,

internal medicine, pediatrics, surgery, dermatology, neurology, ophthalmology, forensic medicine,

epidemiology, and biostatistics

Clinical Experience:

Primary Care Physician

Senen Community Clinic, Jakarta, Indonesia, July 2002 – Feb 2005

• Applied medical concepts and good clinical judgment to provide patient care including diagnosis

and treatment of acute and chronic illnesses, disease prevention, and patient education

• Provided infectious disease and adverse effects following immunization surveillance data per SOP

• Performed physical examinations and ordered appropriate diagnostic tests to establish diagnoses

• Explained benefits and risks of prescribed drug treatments to patients

• Supervised medical physician staff, lab tech/phlebotomist/EKG tech, clinic nurse, and dietitian.

• Developed and conducted clinical staff development activities and in-service training activities.

• Collaborated with other health professionals and utilized consultation or referral as appropriate

Clinical Research Experience:

Clinical Research Assistant

Children Hospital Los Angeles & Los Angeles County Dept of Public Health, Los Angeles, CA Jan-Jun

2009

• Applied of statistical and epidemiological methods to process research data, maintained study

database

• Ensured case report forms are reviewed and submitted in a timely manner

• Monitored all site related activities and files to ensure completion per Standard Operating

Procedure (SOP)

• Wrote protocols and informed consents, assisted with preparation of Institutional Review Board

(IRB) regulatory documents, interacted with physicians to discuss protocols and data collection

processes

• Coordinated a prospective cohort study to evaluate rates of virologically confirmed influenza in

children attending schools with and without school-based vaccination programs

• Performed rapid diagnostic tests to confirm influenza illness, collected and analyzed data from the

test

Clinical Research Assistant

UCLA Center of Community Health, Los Angeles, CA, Nov 2008-Jun 2009

• Coordinated studies on social network analysis to examine the acceptability of a youth-led, hybrid

face-to-face and online social networking HIV prevention program for homeless youth

• Screened, identified, and assessed potential study participants to determine their eligibility for the

study

• Developed survey instruments to collect information through interviews and questionnaires

• Recorded study data in research database, tracked missing information, and monitored study

progress

• Evaluated the adequacy of existing programs and feasibility of planned program

Basic Research Experience:

Graduate Research Assistant

University of California, Riverside, CA, Jun 2010 – Present

• Applied statistical methods to analyze complex data, developed and maintained research databases

• Prepared research manuscripts and presentations to convey scientific data in an understandable

way

• Presented scientific research results in laboratory and department meetings and scientific

conferences

• Designed and performed experiments using various molecular biology techniques

Hilda Wiryawan Curriculum Vitae Page 3

• Managed and trained laboratory personnel in experimentation techniques, laboratory safety, and

GLP

• Characterized a small molecule compound inhibitor of SUMOylation pathway, including

mechanism of action assays with the purpose of guiding clinical studies by providing appropriate

enzymatic strategies

• Developed innovative application of Fluorescence Resonance Energy Transfer (FRET) to measure

enzyme kinetics in SUMOylation pathway and to determine inhibition constant of the small molecule

inhibitor

• Performed cell-based experiments to explore the biology of cancer targets, including high

throughput screening, signal transduction pathways, mechanisms of action, and drug

sensitivity/resistance

• Experienced in protein expression in bacterial, yeast, and mammalian cell culture (CHO, HEK)

systems

Teaching experience

Introductory Organismal Biology Laboratory Teaching Assistant

University of California Riverside, CA, Spring Quarter 2013

• Taught biology laboratory course for twenty four first year college students on topics such as

energetics, prokaryotes, protists, protostomes, body plans and development, animal handling and

dissection

• Demonstrated use of laboratory equipment and enforced laboratory rules

• Informed students of the procedures for completing and submitting class work such as lab reports

• Scheduled and maintained regular office hours to meet with students

Biotechnology and Molecular Bioengineering Teaching Assistant

Biotechnology Laboratory Teaching Assistant

University of California Riverside, CA, Fall and Winter Quarters 2013 - 2014

• Taught 80 3rd and 4th year Bioengineering students about biotechnology and molecular

bioengineering

• Developed discussion materials and quizzes on topics such as molecular cloning, antibody and

other protein production, enzymes, cell growth kinetics, fermentation; to supplement faculty lectures

• Developed, updated and maintained learning management system websites

• Evaluated and graded quizzes, midterm and final examinations

Volunteer Experience:

Dispensary volunteer

UMMA Community Clinic, Los Angeles, CA, May – Oct 2008

• Reduced medication errors through quality control measures by implementing clarity of label

instructions

• Modified the dispensary to improve workflow process to meet the need of a more efficient system

• Promoted health literacy in the clinic by educating vulnerable populations including elderly and

minority

Leadership Experience:

Fellows

Albert Schweitzer Fellowship, Los Angeles, Jun 2008 – Jun 2009

• Addressed a wide variety of unmet health needs by creating and carrying out yearlong projects

with direct service at UMMA Community Clinic

• Collaborated with team of fellows in planning and organizing Schweitzer Global Health

Symposium at UCLA

• Volunteered in several health fair events targeting the underserved communities in Los Angeles

County

Publications

Hilda Wiryawan Curriculum Vitae Page 4

Peer Reviewed Journal Articles

• Wiryawan, H, Liao, J. Determination of SUMO-1, -2, -3, and ATP Affinity for the SUMO E1

Using Quantitative FRET Technology (submitted)

• Chen G, Severo MS, Sakhon OS, Choy A, Herron M J, Felsheim RF, Wiryawan H, Liao J, Johns

JL, Munderloh UG, Sutterwala FS, Kotsyfakis M, Pedra JH. Anaplasma phagocytophilum

Dihydrolipoamide Dehydrogenase 1 Affects Host-Derived Immunopathology during Microbial

Colonization. Infection and Immunity. 2012 Jul; 80(9): 3194-205. Cited in PubMed; PMID:

22753375.

• Kaur Malik-Chaudhry H, Wiryawan H, Shen Y, Liao J. Target SUMOylation and other UBL

pathways for drug discovery. Current Topics in Biotechnology. 2012. 7: 21-29

• Pannaraj P, Wang H, Rivas H, Wiryawan H, Smit M, Green N, Aldrovandi G, Nelson El Amin A,

Mascola L. School-located Influenza Vaccinations Decrease Laboratory-confirmed Influenza and

Improve School Attendance. Clinical Infectious Diseases (accepted)

Abstract Presentations:

• Liao J, Song Y, Liu Y, Kaur H, Saavedra A, Wiryawan H. Development of FRET Technologies

for Quantitative Systems Biology Research of SUMOylation Pathway. BMES Annual Meeting, 2013

Professional Membership

• Drug Information Association (DIA)

• The Albert Schweitzer Fellowship

Grants and Awards:

• Medical Student of the Year, University of Indonesia, Jakarta Indonesia, 1999

• Mary Galvin Burden Endowed Fellowship 2009

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