VirtualVigilance is the vision of Ed Morris, ASQ-CQA and Karin Heston, PharmD, RPh, BCPS, ASQ-CQA. With a combined experience of +40 years in FDA consulting, both Karin and Ed identified an unmet need for a simple, cost-effective solution for Drug Safety case processing. Together, Ed and Karin created VV Drug Safety, the first in a suite of technology solutions that truly puts data ownership within reach of smaller Life Sciences companies. Originally intended for emerging sponsors, VV Drug Safety is also well suited for companies with low case volumes and/or simple products. Beyond just drugs, VirtualVigilance has technology solutions for: • Medical Devices • Drug / Device Combinations • Product Complaints VV technology products are cloud-based allowing clients to rapidly implement without support from IT.
Ed Morris, Co-Founder
With over 20 years of experience in the Life Sciences sector, Ed Morris builds highly efficient GMP and GCP compliance programs. With a background in IT, Ed joined the Biopharmaceutical industry in 2001 with Sentrx, a Drug Safety service provider. Over the next 20 years, he gained experience across the entire drug / device development chain from Research to Clinical Development, Quality Management, Manufacturing and Commercialization.
In 2021, Ed obtained his ASQ certification as a Quality Auditor and continues to lead Quality Assurance projects including QMS implementation, audit remediation and Computer Systems Validation for emerging pharma.
Ed has recently launched a new company, VirtualVigilance which develops Adverse Event technology solutions for emerging companies.
Karin Heston, Co-Founder
As a Board-Certified Doctor of Pharmacy with over 25 years of experience in global brand and generic pharmaceutical industry and hospital-based pharmacy practice, Karin Heston is an expert in Pharmacovigilance (GVP), Drug Safety & Risk Management, with experience creating, implementing, directing and auditing multi-national clinical & post-marketing safety activities and benefit:risk management programs for prescription, over-the-counter, device, cosmetic, vaccine & biosimilar compounds.
In addition to her Board Certification in Pharmacotherapy (1999), Karin has also obtained ASQ – Quality Auditor (2020), Pharmacogenomics (2018) and Medication Therapy Management (2015) Certifications and is a Registered Pharmacist in two states.