Lisa Rinker
Senior Director, Safety Science, Pharmacovigilance
Expertise:
Lisa brings more than 20 years of experience in pharmacovigilance operations and safety surveillance process development, vendor oversight and safety data exchange agreements to EVERSANA. She has expertise in the therapeutic areas of rare diseases, oncology and anti-infectives.
Lisa began her career at Merck Research Laboratories and was responsible for the launch of the pharmacovigilance departments at ViroPharma and Idera Pharmaceuticals. While at ViroPharma, she led the setup of pharmacovigilance operations in Europe as part of country licensing opportunities. She holds a master’s degree in pharmacy, quality assurance and regulatory affairs from Temple University and a bachelor’s degree in biology from Immaculata College.
Articles by Lisa Rinker
COVID-19 Vaccine Safety Briefing Report
As the world awaits the fast-approaching rollout of an approved COVID-19 vaccine, developing the planning to order, distribute and track COVID-19 vaccines in the United States and globally presents an unprecedented challenge. The Food and Drug Administration (FDA) released a detailed analysis that concluded that the Pfizer and BioNTech COVID-19 vaccine is effective and safe, leading the way for the FDA to grant the vaccine an emergency use authorization. While there is much enthusiasm around the shift from the development of the vaccine to its distribution phase, it’s critical to consider the various regulatory guidelines and approaches to monitoring the safety data in real time. Read our latest safety briefing […]
What Happens After a COVID-19 Vaccine Trial Succeeds? 4 Pharmacovigilance Challenges to Address During Commercialization
As pharma companies continue to develop COVID-19 vaccines around the world, they are faced with these questions: What happens when we succeed? How will we quickly and safely distribute the vaccine globally? Pulling off this rapid, international drug distribution safely will require excellence in agility and compliance integrated across commercial services. For pharma companies to successfully market the lifesaving COVID-19 vaccine, they’ll have to overcome pharmacovigilance challenges in four major areas of commercialization: Mass Data Collection Regulatory & Safety Reporting Patient Services Mass Manufacturing & Distribution Click here to read more about meeting these compliance standards in this article by Nina Patel Lahanis, Associate Vice President of Safety Science, EVERSANA […]