Director Global Pharmacovigilance - Safety Physician 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, such as 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 for presenting decisions from the Product Safety Group to senior governance committees and Teva's top management.
Perform 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 the 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 well 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.
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