Teva Director Global Pharmacovigilance - Safety Physician 

Spain, Community of Madrid, Madrid 

146144010

• 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.

• 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

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