.Director Global Pharmacovigilance - Safety Physician Date: Sep 23, 2024 Location: Madrid, Spain, 28108 Job Id: 58386 Together, 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. The opportunity Teva 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. 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. 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. Perform medical review of ICSRs for assigned products from clinical trials. Accountable for medical evaluation/interpretation of aggregate safety data of assigned products. Lead risk management activities for assigned products globally. Represent PV on the cross functional Product Label Working Group. Guide, provide support and train, as applicable, PV scientists across safety surveillance activities. Collaborate with different functions both in Teva and outside Teva. Support global launch activities for assigned products. Perform due diligence on product safety profile of potential new assets. Your experience and qualifications MD or equivalent. Completion of an accredited Residency/ Specialty program and is Board Certified or Eligible. 5 year minimum working in pharmacovigilance and drug safety area as a safety physician. Strong knowledge of FDA and EMA regulations (GVP, GCP). Experience with NDA/BLA submissions in the US and MAA in Europe. Experience in managing safety issues in pre-and post-marketing environment. Proven abilities on handling safety surveillance tasks. Ability to work cross-functionally with an international team across multiple time-zones. Excellent communication skills in speaking and writing English