Vaiyapuri Subramaniam, Pharm.D., M.S., FCP, FASHP, FASCP
Associate Chief Consultant and Director, Adverse Drug Events Program
Reporting Program Management, Pharmacy Benefits Management, Department of Veterans Affairs
Pharmaceutical Compliance Officer, Regulatory Affairs and Drug Compliance, Food and Drug Administration

Role
Dr. Vaiyapuri Subramaniam is currently associate chief consultant and director of adverse drug event (ADE) reporting programs at the U.S. Department of Veterans Affairs (VA) Central Officer, Pharmacy Benefits Management Strategic Healthcare Group (PBM SHG).  He manages the PBM SHG national ADE reporting system in collaboration with Veterans Affairs medical center (VAMC) facilities nation-wide.  Dr. Subramaniam serves as a subject matter expert on ADE reporting systems and pharmacotherapeutic management.  In addition, he fulfills executive pharmacy management responsibilities on pharmacy affairs and policy matters.  He also leads the VA PBM SHG’s initiatives in compliance and planning for USP 797 Sterile Drug Compounding provisions and collaborates within the VA on new initiatives in the agency’s web based ADE reporting systems and surveillance.

Previously, he was a compliance officer at the Food and Drug Administration (FDA) and was involved in various programs dealing with drug regulatory compliance, medication errors, adverse drug experience regulations, post marketing drug surveillance, and drug labeling and nomenclature consultation. As a CSO, he ensured that pharmaceutical manufacturers comply with specific requirements in adverse drug event reporting regulations.

He has been active in international pharmacy activities and regulatory affairs and has participated actively in speaking on ADE and drug quality program management, public health pharmacy and pharmaceutical regulatory affairs both while at the FDA and currently.

At the FDA, Dr. Subramaniam coordinated regulatory compliance matters with other FDA offices to resolve drug product labeling issues. Other team efforts include developing scientific and public health initiatives in FDA’s post marketing drug surveillance programs. Dr. Subramaniam’s job also requires him to speak on behalf of the FDA at national and international pharmaceutical conferences, promoting the role of pharmacists in drug quality surveillance programs and disseminating safety, labeling, and quality information on marketed drug products.

Many of Dr. Subramaniam’s activities include collaboration with team members in post marketing drug quality surveillance. Significant findings from FDA’s drug surveillance are shared with pharmaceutical manufacturers who may then take corrective actions in order to assure drug product quality.

How They Got There
After receiving his B.A. degree from Ohio Wesleyan University, Dr. Subramaniam continued on to graduate school for a year to find his niche. At the suggestion of his chemistry professors, he met with the Dean of Pharmacy College at Ohio Northern University, who encouraged him to apply to the five-year pharmacy program. He followed this advice and graduated in 1974 with a B.S. in Pharmacy.  Subsequently, he received his Master of Science degree in Management and following that the Doctor of Pharmacy degree from the University of Arkansas for Medical Sciences.

Prior to joining the FDA, Dr. Subramaniam was a staff pharmacist in a community pharmacy practice, then moved on to various positions including clinical pharmacist and teaching coordinator, quality assurance coordinator, and director of pharmacy services at various hospitals in the Washington DC area.

Other Professional Activities
Dr. Subramaniam has co-authored research abstracts and publications covering issues such as public health pharmacy, drug labeling studies, pharmacy compounding, drug quality sampling research. After appointment by the U.S. Surgeon General in 1999, he became a member and is now Chair of the Professional Relations Committee, which is part of the Pharmacist Professional Advisory Committee (PharmPAC).

Dr. Subramaniam is extremely active in other professional associations including FDA’s Labeling and Nomenclature Committee, FDA’s Medication Errors Subcommittee, ASHP, APhA, ASCP, Regulatory Affairs Professionals Society, and the International Pharmaceutical Federation. He has held leadership positions with the Post Market Surveillance Workgroup, the Society of FDA Pharmacists, and its Board of Directors. He is a past President of the Washington Metropolitan Society of Health System Pharmacists. He is also a Fellow of American College of Clinical Pharmacology, the American Society of Health-System Pharmacists and the American Society of Consultant Pharmacists. As a Senior Fellow of the Council for Excellence in Government, he is involved in developing pharmacy leadership, best practices, and excellence in the profession.

Dr. Subramaniam is a Clinical Affiliate Professor for pharmacy students at the Department of Veterans Affairs PBM SHG, for the Nova Southeastern University College of Pharmacy and University of Maryland School of Pharmacy.

Advanced Training and Professional Opportunities
The VA offers excellent opportunities for pharmacists as a career path in a variety of responsibilities and settings in primary care, clinical pharmacy, pharmacy informatics and management.  Pharmacists following their graduation from pharmacy school can do a residency at VA medical centers nation-wide and find a niche’ in their area of interest as practicing pharmacists to pursue a career path.

Being a pharmacist with the FDA requires a pharmacy degree, professional licensure, and, preferably, a level of professional experience that the individual can bring into FDA and make a difference for pharmacy in pharmaceutical affairs, policy making and regulatory affairs. Exceptional skills in communication, writing, organization, and teamwork are certainly helpful.

Advice
“ As pharmacists today, assume roles as clinicians and leaders, both attributes critical to excellence in patient care that can be promoted through collegiality, understanding, communication, and above all a respect for our profession. Take the lead in volunteerism and community leadership related to public service and health, because the future is increasingly in our hands.”