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EVELYN M.

RODRIGUEZ MD, MPH, MBA


Mountain Lakes, NJ 07046 / 862-812-2885 / drevelynrodriguez@yahoo.com http://webprofile.info/erodriguez/

SVP / CHIEF MEDICAL OFFICER / PUBLIC HEALTH EXECUTIVE


Award-winning medical executive with deep expertise in clinical medicine, epidemiology and health outcomes, medical product development, pharmaceutical regulatory sciences supporting global pharmaceutical/biotech companies and public health organizations. Successful at building and leading diverse, high-performance teams that collaborate to achieve aggressive program goals in epidemiology, pharmacovigilance, and public health. Highly effective at leveraging stakeholder relationships, key resources, and leadership skills to promote public health, drug development, drug safety, and risk management. Visionary strategist with proven ability managing regulatory/compliance issues, multimillion-dollar budgets, and drug development for global drug/biotech companies. Possess unique combination of medical, public health, and business expertise as a licensed, dualboard physician with both MBA and MPH. Bilingual in English and Spanish. External Environment Assessment & Evaluation Medical Regulatory Compliance Public Health/ Epidemiology Strategic Planning & Tactical Execution Pharmacovigilance / Pharmacoepidemiology Medical & Clinical Research Team Leadership & Collaboration Leveraging Stakeholder Partnerships

PROFESSIONAL EXPERIENCE
JANSSEN ALZHIEMER IMMUNOTHERAPY San Francisco, CA 2010 2011 Subsidiary of Johnson & Johnson dedicated to developing treatments for Alzheimer's disease. VP, Global Pharmacovigilance & Risk Management Managed day-to-day operations supporting global pharmacovigilance and risk management programs. Oversaw 20 direct/indirect reports and $5 million budget. Accountable for all aspects of drug safety studies from overseeing strategic planning and risk management functions to developing program goals, processes, policies, and procedures. Approved medical safety reviews. Reviewed all safety documents, clinical trial reports, and risk management plans. Planned safety and risk management activities in preparation for filing first NDA. Led team in gathering and presenting information to alleviate FDA and regulatory concerns worldwide regarding Phase 3 clinical trial, securing approval to sell first disease modifying treatment for 35 million patients with Alzheimers disease. Worked closely with contractors to establish blueprint to create Risk Evaluation Minimization (REMS) systems, ensuring adherence to drug development milestones in treating Alzheimers disease, a projected $10.1 billion market by 2020. Achieved inspection compliance with FDA and global regulatory agencies as result of leading departmental effort to rewrite and consolidate 20+ documents into nine SOPs as part of recent corporate acquisition. Improved inspection readiness and compliance with FDA/global regulatory requirements regarding drug development after spearheading implementation of Argus database with related training four months ahead of schedule. RODRIGUEZ HEALTH CONSULTING SERVICES, LLC Mountain Lakes, NJ 2009 2010; 2011 - Present Health-based consulting firm specializing in clinical risk assessment and management activities. President Oversaw daily operations for consulting firm providing global safety surveillance, safety data review, signal detection, and risk assessment/management services. Planned and coordinated working groups to develop risk management and REMS. Conducted medical reviews and coding for adverse event case reports and clinical assessments for causality. Prepared summary medical assessments. Provided medical monitoring, safety review of study protocols, IBs, safety monitoring plans, CSRs, line listings, IND annual reports, PSURs, and other clinical safety regulatory reports. Performed medical review of individual and aggregate cases to enable company to respond to regulatory queries in short turnaround time that protected drug labels while safeguarding product availability and patient safety. Maintained profitability and maximum patent protection for client products by developing and implementing risk management plans to position clients to file NDAs (New Drug Applications) according to milestones. BAYER HEALTHCARE Montville, NJ 2005 2008 Global research-based pharmaceutical company with sales exceeding EUR 16.9 million. VP, Global Pharmacoepidemiology Provided pharmacoepidemioiogical, medical, and regulatory executive leadership with oversight for five direct reports including two student interns. Directed and participated in all safety assessments and risk management for biological and pharmacological products in post marketing and development phases. Accountable for developing and implementing strategies, program goals, best practices, and standard operating procedures/processes supporting pharmacoepidemiological studies and risk management plans. Maintained compliance with applicable regulations. Provided guidance in drug safety, regulatory matters, and life cycle/risk management.

EVELYN RODRIGUEZ, Professional Experience, Continued

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Maintained product continuity by devising and implementing strategic staffing plans to provide routine product safety signal and medical reviews to regulatory authorities in timely manner. Maximized profits as result of closely tracking and managing 5 million euros operating budget and key resources to address project/program priorities in meeting regulatory and risk management requirements for product portfolios. Saved and positioned companys cash cow product for market growth after cultivating and maintaining key relationships with industry partners, regulatory entities, and scientific colleagues to address companys worldwide regulatory product concerns. Ensured product availability by establishing network of consultants to address pharmacoepidemiological communications and risk management needs including organizing and chairing first company-sponsored Epidemiology and Risk Management Advisory Boards. Increased product earnings and patent protection through design and roll out of risk management plan for new drug indication in three weeks time that enabled company to meet its filing milestone. NPS PHARMACEUTICALS, LLC Bedminster, NJ 2004 2005 Outsourced-based biopharmaceutical product development company. VP, Global Pharmacovigilance Directed all activities related to drug/device safety studies and risk management. Oversaw SOPs, program requirements, medical safety reviews, clinical trial reporting, and regulatory document documentation regarding drug safety. Performed global safety surveillance and data reviews. Designed and supervised studies to support products in development and post marketing phases. Leveraged key relationships to meet regulatory requirements. Successfully filed companys first new drug application on time after setting up and leading department with new staff to identify and resolve highly complex pharmacoviligance and risk management issues. Shortened submission times for filing companys first new drug application (NDA) by six months and secured key funding as result of directing safety and risk management planning efforts. Laid framework for maximizing drug safety through creation of pharmacovigilance agreement between NPS and its European marketing partner. Spearheaded efforts to implement companys first safety database to comply with regulatory requirements serving as essential component for filing company's new drug application. Averted millions of dollars in potential fines by providing company leadership to Data Safety Monitoring Board to ensure regulatory compliance and Good Clinical practice for biological drug addressing short bowel syndrome. NOVARTIS PHARMACEUTICALS, INC. Basel, Switzerland 2002 2004 Multinational pharmaceutical company with annual sales exceeding $41 billion. VP, Global Pharmacoepidemiology Planned and led epidemiological studies and evaluations to assess and manage safety risks for products in both development and post marketing phases. Supervised 15 direct/indirect reports. Defined and aligned departmental strategies with corporate goals. Evaluated program performance. Served as organizational representative in field of pharmacoepidemiology. Counteracted 50% in staff departure and low morale by designing and deploying global staffing strategy that involved hiring and training international team across multiple locations, promoting environment of teamwork and mutual trust. Safeguarded product investments after planning and coordinating 6 million euros in departmental budgets and key resources supporting projects and programs that addressed training and scientific needs of company. Boosted firms credibility and visibility as result of delivering presentations at international scientific meetings and authoring publications in peer reviewed journals. Introduced concept of risk management supporting development of several high-profile products including Zelnorm. FDA (Office of Science & Epidemiology) Rockville, MD 1998 2002 Organization responsible for evaluating safety profiles of drugs available to American consumers. Director, Division of Drug Risk Evaluation (1998 2002) Served as one of two Division Directors directing drug safety surveillance, epidemiological science, and risk management activities. Supervised and trained up to 45 staff members. Accountable for post-marketing evaluation of adverse drug reaction reports, signal generation, industry safety submissions, drug safety evaluations, and follow-up of drug safety issues. Developed, implemented, and maintained post market drug risk assessment policy, guidance, and interpretations. Created six-month staffing plan to hire highly-skilled employees to help address multiple drug withdrawals from US market. Spearheaded initiative to create new Office of Science and Epidemiology that included forming organizational structure, planning promotions, and fully staffing office servicing organizations drug safety consulting needs for the agency. Received Annual Best Paper Award for reporting lack of compliance and how physicians interpret labeling recommendations in their practice, resulting in creating a sea change in worldwide legislations, regulations, and creation of risk management systems Europe and the US (REMS). First to propose sentinel drug safety surveillance to scientific and regulatory communities that laid groundwork for FDAAA legislation to implement safety monitoring systems, enabling access to data for 100 million people by July 2012.

EVELYN RODRIGUEZ, Professional Experience, Continued

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Acting Chief, Epidemiology Branch (1998) Managed branch with oversight for conducting epidemiological studies in support of review divisions. Developed and executed policies associated with post-market drug risk assessment. Managed cooperative agreements for multi-agency epidemiologic studies to identify risks posed by specific drugs and correlation between adverse reactions and drug usage. Developed business processes to improve synergy between disciplines. Integrated and supported new group to assess drug safety signals. Led efforts to integrate Medical Epidemiologists with Pharmacologists/Drug Safety Evaluators supporting Office of Science and Epidemiology to proactively address drug safety issues for entire agency. HEALTH RESOURCES & SERVICES ADMINISTRATION Rockville, MD 1995 1998 Federal agency for improving access to health care services for people who are uninsured, isolated, or medically vulnerable. Chief, Program Development Branch (1997 1998) Promoted to provide development of policies and programs to increase number of health professionals entering field from disadvantaged and minority backgrounds through grants and cooperative agreements. Oversaw four direct reports. Drafted new program mission statement providing vision for the programs. Administered portfolio of grants and contracts valued at tens of millions of dollars to colleges and universities for recruitment and retention of hundreds of minorities in health sciences. Associate Director, Research / Senior Medical Officer (1995 1997) Led HIV/AIDS research studies and assessment of HIV/AIDS health programs. Co-managed and designed multimillion-dollar SAMHSA/HRSA/NIMH HIV/AIDS Mental Health Services Demonstration Project. Oversaw proposal review for grant program involving study of youth infected with HIV. Represented Division of Organ Transplantation with United National Organ Transplantation Network. Developed and launched first demonstration grant program to create tailored programs to screen, treat, and provide health related services to tens of thousands of adolescents infected with HIV.

PREVIOUS WORK HISTORY


CDC Epidemic Intelligence Service Officer, Maryland Dept. of Health & Mental Hygiene, Baltimore, MD* Medical Officer, National Institute of Allergy & Infectious Diseases, Rockville, MD Pediatric Physician, Kaiser Permanente Medical Group, Rockville, MD 1993 1995 1989 1993 1989 2002

EDUCATION / CERTIFICATIONS
M.B.A., Fairleigh Dickinson University, Madison, NJ M.P.H., (Major: Epidemiology), Columbia School of Public Health, New York, NY M.D., Harvard Medical School, Boston, MA B.S. in Biology, Saint Francis College, Brooklyn, NY Certifications: Public Health & General Preventive Medicine, American Board of Preventive Medicine; General Pediatrics, American Board of Pediatrics; Medical Boards, National Board of Medical Examiners; Fellow, AAP; Fellow, International Society of Pharmacoepidemiology

TRAINING Mellon Fellow, Sergievsky Center, Columbia University Pediatric Resident & Visiting Clinical Research Fellow, Babies Hospital of the Columbia-Presbyterian Medical Center Pediatric Intern, Childrens Hospital (Boston)

SELECTED PUBLICATIONS
Rodriguez EM, Boateng CB, Martinez CM. Association of Erectile Dysfunction and Hearing Loss: Confounding by Age. Submitted. Wysowski DK, Corken A, Gallo-Torres H, Talarico L, Rodriguez EM. Reports of QT Prolongation and Ventricular Arrythmia in Association with Cisapride and Food and Drug Administration Regulatory Actions. Am J Gastroenterology 2001: 96(6); 1698-1703. Cluxton RJ, Zili L, Heaton PC, Weiss SR, Zuckerman IH, Moomaw, CJ, Van Doren H, Rodriguez EM. Impact of Regulatory Labeling for Troglitazone and Rosiglitazone on Hepatic Enzyme Monitoring Compliance: Findings from the State of Ohio Medicaid Program. Pharmacoepidemiology Drug Safety. 2005; 14: 1-9. Senior Author and Principal Investigator, 2006 Annual Award Winner for Best Paper. Rodriguez EM, Staffa, JA, Graham DJ. The Role of Databases in Drug Pharmacoepidemiology Drug Safety. 2001 Aug-Sep; 10(5); 407-10.

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