Edwin Rivera

Background

About Edwin Rivera

I have been in the industry for about twenty-four years working for five different companies including Johnson & Johnson/Kenvue where I am working currently as Senior Oversight Product Vigilance Physician. My goal is to maximize the benefit-risk ratio of medicinal products for safe use in our patients My expertise in Pharmacovigilance, clinical research, and medical affairs across various pharmaceuticals companies has provided me with opportunities to uphold the benefit, effectively analyze risk, and developed risk minimization practices to get the right products to the right patients. Areas of expertise in safety included gastrointestinal, oncology, cardiovascular, oncology, hematology, metabolism and nutrition, allergy, respiratory, immunology, and consumer products. I enjoy leading by example and inspiring others to achieve not only key business results, but their maximum potential of personal and professional growth as individuals-Senior Pharmacovigilance Physician with vast experience in medical review of single cases and aggregate review across pharmacovigilance, clinical research, and medical affairs-Safety Management Team Chair, leading Medical Safety globally to make the decisions of all safety related concerns for products-Effective communication of safety related issues and risk-benefit of products to senior leaders. Collaborated with clinical, medical affairs, quality, regulatory and legal department-Successful in leading global safety teams: direct and functional management of up tp twenty-four physicians in the multidisciplinary team. Creation of ONE PVP (pharmacovigilance physician) Team to ensure consistency and aligment between sector; like medicinal and non-medicinal groups. Provided training in pharmacovigilance to different groups-Led process improvement in medical safety including technology assessment and implementation of safety tools. Owner of Standard Operations Procedures (SOPs) for medical review including cross-sector alignments-Experienced in restructuring existing safety departments in larga Pharma companies, as well as building new safety organizations. Effective organization through outsourcing and other resources. Provided pharmacovigilance support to internal and externally -Comprehensive knowledge and experience in REMS, global risk minimization measures, and patient support programs._Global experience with different Health Authorities including request and corrective action plans-Seven years of medical practice in Vascular Surgery and Hematology.