What are the responsibilities and job description for the Regulatory Specialist position at ProPharma Group?
Company Overview
ProPharma Group is the world's largest Research Consulting Organization, providing advice and expertise to biotech, med device, and pharmaceutical organizations for over 20 years.
Job Description
We are seeking a highly skilled PV Case Processing Specialist to join our team. As a key member of our Pharmacovigilance department, you will be responsible for daily case processing of adverse event cases, including coding using MedDRA, determining seriousness and expectedness at the event and case level.
You will perform case follow up activities such as identification of information to be collected during follow-up, creating and reviewing case narratives, and providing client notifications as required for case management.
In addition, you will support and contribute to the development of training materials and training delivery, highlight areas of concern/discrepancies to the Principal PV Specialist, Case Processing and/or Manager, Case Processing when related to ICSRs, and acquire and maintain an up-to-date knowledge of global safety regulations for medicines.
