Director Global Pharmacovigilance

hace 2 meses


Madrid, España Teva Pharmaceutical Industries A tiempo completo

.Who we areTogether, 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.The opportunityTeva Pharmacovigilance unit is hiring a physician for the Safety physician, Director Pharmacovigilance role to join the Medical Scientific Unit (MSU) and support safety in projects under development. In this unit we lead drug safety across the entire Teva portfolio and throughout the product lifecycle. In partnership with other Teva stakeholders, our MSU safety physicians and scientists identify and define the risks of our drugs and propose measures to minimize or mitigate them. In this way, we maximize the benefit-risk ratio of Teva drugs and provide comprehensive safety information to patients, prescribers and regulators.The locationThis role can be based in any European country, where Teva has offices/sites.How you'll spend your day* Lead the safety profile of the assigned product(s) during clinical development including Company Sponsored studies, Investigator Sponsored studies, Compassionate Use and Disease Monitoring Programs. Collaborate with other R&D teams to ensure execution of the safety strategy.* Contribute to clinical documents, (e.G. 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, and other relevant safety related clinical documents).* Lead and chair the cross functional Product Safety Group. Be responsible to present decisions from Product Safety Group to senior governance committees and Teva's top management.* Performing medical review of ICSRs for assigned products from clinical trials* Accountable for medical evaluation/interpretation of aggregate safety data of assigned products including signal detection and evaluation, regulatory safety reports (PSUR, PADER, DSUR), and ad hoc safety review/assessments of assigned and other products* Lead 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 product's life cycle.* Represent PV on the cross functional Product Label Working Group



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