Director Global Pharmacovigilance

Press Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Director Global Pharmacovigilance - Safety Physician Date: Aug 29, 2025 Location:Warsaw, Poland, 00 Job Id: 63755 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. 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 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. In this way, we maximize the benefit-risk ratio of Teva drugs and provide comprehensive safety information to patients, prescribers and regulators Location This role can be based in Netherlands (Haarlem) or Poland (Warsaw). 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. Lead evaluation and determination of safety related sections of the product label, both initial and throughout the product lifecycle; key member for safety related label negotiations with regulatory agencies as well as in the development of internal CCSI Guide, provide support and train, as applicable, PV scientists across safety surveillance activities such as; medical review, signal detection and risk evaluation activities. Collaborate with different functions both in Teva (Medical Affairs, Clinical Development, Quality etc.) and outside Teva (KOLs CROs etc.) to effectively communicate PV position on any safety concerns as we as the overall safety profile of assigned products. 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 Experience in drug development immunology or neurology therapeutic areas is a plus 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 handing safety surveillance tasks and chairing safety committee meetings. Ability to work cross-functionally with an international team across multiple time-zones. Excellent communication skills in speaking and writing English Reports To Already Working @TEVA? If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site The internal career site is available from your home network as well. If you have trouble accessing your EC