About Medical Vigilance Solutions

Our History

Medical Vigilance Solutions’ origins date back to 1966 when Cincinnati Children’s launched its Drug and Poison Information Center (DPIC). Six years later, DPIC expanded to become an accredited drug information and poison control center. In 1982, DPIC established its first industry partnership, and Medical Vigilance Solutions was born.

Now, almost 40 years later, MVS is a distinct and specialized business unit of Cincinnati Children’s, one of the best pediatric hospitals and research organizations in the U.S. A portion of our revenue continues to support the mission of Cincinnati Children’s.

Medical Vigilance

Meet Our Management Team

Dustin Weiss, Director PVMC

Dustin Weiss

Director PVMC

MVS team Member Denise Schmidt

Denise Schmidt
MSM

Manager,
Quality Assurance

Samantha Colburn, Manager Pharmacovigilance

Samantha Colburn

Manager Pharmacovigilance

Ben Walz, Senior Business Development Consultant

Ben Walz

Senior Business Development Consultant

Stephanie Carroll, Manager Pharmacovigilance

Stephanie Carroll

Manager Pharmacovigilance

Samantha Atoyan, Business Manager

Samantha Atoyan

Business Manager

MVS team Member Lauren Shelton

Lauren Shelton
RN, BSN

Manager,
Pharmacovigilance Operations

MVS team Member Nancy Smith-Hall

Nancy Smith-Hall
PharmD

Pharmacovigilance Analyst

MVS team Member Debbie Roll

Debbie Roll
RPh, CSPI

Project Leader,
Medical Communications

MVS team Member Mike Schur

Mike Schur
PharmD

Leader,
Medical Information Operations

MVS team Member Anne Flohr

Anne Flohr
RPh

Pharmacovigilance Analyst

MVS team Member Gary Galletta

Gary Galletta
PharmD

Pharmacovigilance Analyst

MVS team Member Sara Stover

Sara Stover
PharmD

Project Leader,
Medical Communications

MVS team Member Robyn Davis

Robyn Davis
RN, MSN

Manager,
Medical Communications

  • Oversees all medical communications and pharmacovigilance activities
  • More than eight years of pharmacy experience in various outlets
  • Bachelor’s in Biology and Doctor of Pharmacy (PharmD) from the University of Cincinnati; Master’s in Business Administration from Thomas More University
  • Over 15 years in regulated industries including Pharmaceutical and Medical Device experience in Quality Control, Quality Assurance and Manufacturing.
  • Responsible for Regulatory Compliance, Process Improvements, Document Management, Training, Validation, Audits, CAPAs, Change Controls and Metrics
  • Wide range of experience in understanding and implementing cGMP, FDA and foreign market regulations
  • Bachelor of Science in Wildlife Management from Eastern Kentucky University and Master of Science in Management from Indiana Wesleyan University
  • Over 10 years of pharmacovigilance and medical communications experience
  • Experience as contact center agent managing calls for variety of products
  • Broad experience collecting, managing, and reviewing safety data from a variety of sources (literature, consumer, regulatory, etc.) and assessing the data with accuracy and in accordance with established timelines to identify trends and issues
  • Responsible for providing daily leadership and developing and maintaining processes and staffing resources in support of pharmacovigilance function
  • Doctor of Pharmacy, PharmD, from University of Cincinnati
  • Responsible for new business development, client relations, contracting, marketing and strategic planning
  • More than 16 years of healthcare client relations and business development experience
  • Bachelor’s in Communications and Marketing from Northern Kentucky University
  • Over five years of pharmacovigilance experience within the pharmaceutical industry
  • Responsible for providing daily technical and administrative leadership around safety operations, including pre- and post-marketed drugs; devices; biologicals and product complaints
  • Develops, maintains, and manages processes and staffing resources supporting the PVMC function
  • Responsible for recruitment, development, and retention of staff; ensures staff education and compliance with standard operating procedures, internal policies, and FDA requirements for reporting adverse events to regulatory agencies
  • Bachelor of Science in Nursing from University of Cincinnati, Master of Science in Nursing from Mount St. Joseph University
  • Over 18 years of financial and operational leadership experience in clinical, research, and academic medicine
  • Oversight of financial controls, budgeting, and internal forecasting
  • Manages business team and ensures efficient operations and workflow
  • Development and implementation of business goals and strategic planning
  • Bachelor of Science in Business Administration from Indiana Wesleyan University and Master of Health Administration from Mercy College of Ohio
  • 14+ years pharmacovigilance safety surveillance experience within the pharmaceutical industry
  • Responsible for the recruitment, training, and development of pharmacovigilance staff
  • Proactively maintains expertise in applicable safety regulations to maintain compliant safety systems and procedures
  • Lead organizational and workflow efficiency within pharmacovigilance services which include adverse event intake, follow up, data entry, coding, regulatory reporting and quality assurance
  • 20+ years of Pharmacovigilance experience, clinical studies and marketed products
  • Expertise in global post marketing safety reporting requirements
  • Responsible for safety data analyses, including signal detection, periodic reporting (PADER, PSUR, PBRER), label change submissions and benefit-risk analysis
  • Experienced in product label development of core and global labels
  • Literature review for safety reporting and product-disease category knowledge
  • 25 years of medical communications experience
  • Currently oversees multiple medical communications programs, driving overall project delivery
  • Provide and/or coordinate training, ongoing coaching, and quality management review for Medical Information Agents
  • Broad therapeutic experience as a contact center agent managing calls for numerous clients covering a wide variety of pharmaceutical products
  • Certified Specialist in Poison Information (CSPI) by the American Association of Poison Control Centers (AAPCC)
  • Bachelor of Science of Pharmacy degree from the University of Cincinnati
  • Interests include technology utilization, process improvement, quality assurance, metrics, and writing
  • Has worked in the Pharmaceutical Industry for over 18 years, including 12 years in-house for multiple pharmaceutical companies
  • Has held various roles in medical information contact centers, medical communications, and medical affairs. He has led MSL training and support teams, and has served as an MSL in the field
  • Received his BS Pharmacy and PharmD degrees from the University of Cincinnati and completed a pharmacy practice residency at Boston Medical Center
  • 8+ years of medical communications experience within the pharmaceutical industry
  • 4+ years of pharmacovigilance experience within the pharmaceutical industry
  • Currently oversees pharmacovigilance contact center
  • Has expertise in a wide variety of medical information and pharmacovigilance activities including communicating scientific information, adverse event and product quality reporting, case assessment and periodic report writing
  • Bachelor of Science degree Rutgers University College of Pharmacy; Pharmacy Practice Residency, University of Cincinnati Medical Center
  • 23+ years experience in pharmaceutical industry, including clinical monitoring, medical affairs, regulatory affairs, and most recently 4+ years in pharmacovigilance
  • Experience in pharmacovigilance case assessment and report generation
  • Bachelor of Science and Doctor of Pharmacy (PharmD) degrees from The Ohio State University and The University of Texas Health Science Center at San Antonio. Pediatric pharmacy residencies at Nationwide Children’s Hospital, Columbus Ohio, and James Whitcomb Riley Children’s Hospital Indianapolis, Indiana
  • 20+ years of experience within pharmaceutical industry
  • Expertise in a variety of medical affairs, medical communications, pharmacovigilance, and research and development activities
  • Bachelor of Science in Pharmacy from Purdue University and Doctor of Pharmacy (PharmD) from Shenandoah University
  • 10+ years of medical communications experience
  • Broad therapeutic experience as a contact center agent managing calls across a wide variety of pharmaceutical products
  • Certified Specialist in Poison Information (CSPI) by the American Association of Poison Control Centers (AAPCC)
  • Provide and/or coordinate training, ongoing coaching, and quality management review for Medical Information Agents
  • Bachelor of Arts in Biology from Tusculum College and Master of Science in Nursing from Xavier University