Buen Salario Director, Global Pharmacovigilance - Neurology Safety Physician (Location: Eu Or Uk)

.Press Tab to Move to Skip to Content LinkSelect how often (in days) to receive an alert:Director, Global Pharmacovigilance - Neurology Safety Physician (Location: EU or UK)Date: May 24, 2024Location:Madrid, Spain, 28108Job Id: 50597Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.This role can be based in any EU country or the UK, where Teva has offices/sites.The opportunityAs a Director, Global Pharmacovigilance - Neurology Safety Physician you will be part of the Global Pharmacovigilance (PV) and Medical Scientific Unit (MSU) supporting drug safety across the entire Teva portfolio and throughout the product lifecycle.You will lead activities necessary to determine the safety profile and the characterization, monitoring, and mitigation of risks of assigned products during clinical development and post marketing, including Company / Investigator Sponsored studies, Compassionate Use and Disease Monitoring Programs.How you'll spend your dayCollaborate with other R&D teams to ensure execution of the safety strategyContribute to clinical documents, (e.G. study protocol, IB, informed consent/assent form, clinical study report, integrated summaries of safety, Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC requests, briefing books, DMC charters, Medical Monitoring Plans, Statistical Analysis Plans and other relevant safety related clinical documents)Lead and chair the cross functional Product Safety Group. Be responsible to present decisions from the Product Safety Group to senior safety governance committees as well as other forums attended by Teva Senior managementPerform medical reviews and assessments of ICSRs for assigned products from clinical trialsTake accountability for medical evaluation/interpretation of aggregate safety data of assigned products, including signal detection and evaluation, dose escalation evaluations, regulatory safety reports (PSUR, PADER, DSUR), and ad hoc safety review/assessments of assigned and other productsLead risk management activities for assigned products globally and contribute to the preparation of Risk Management Plans (RMPs), REMS, as well as management of these plans throughout products life cycleRepresent PV on the cross functional Product Label Working Group