Teva Associate Director Pharmacovigilance - Safety Physician Location Europe UK 

Romania, Bucharest 

977433760

• Lead activities necessary for the determination of the safety profile and the characterization, monitoring, and mitigation of risks of assigned products during clinical development and/or post marketing including, as applicable, company sponsored studies, investigator sponsored studies, compassionate use, and disease monitoring programs. Collaborate with other R&D/cross-functional teams to ensure execution of the safety strategy.
• Contribute to clinical documents (e.g., study 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, DMC charters, Medical Monitoring Plans, Statistical Analysis Plans, and other relevant safety related clinical documents).
• Lead and chair the cross-functional Product Safety Group. Be responsible for presenting decisions from Product Safety Group to senior safety governance committees as well as other forums attended by Teva’s senior management.
• Perform medical review and assessment of ICSRs for assigned products from clinical trials.
• Being accountable for medical evaluation/interpretation of aggregate safety data of assigned products including signal detection and evaluation, dose escalation evaluations, regulatory safety reports (PSUR, PADER, DSUR), and ad-hoc safety reviews/assessments (such as Health Hazard Assessments, abbreviated safety evaluations, and Health Authority requests).
• Perform signal management activities such as signal validation QC, authoring of complex signal evaluations, and signal evaluation review. Act as medical reviewer to assess causality, consolidate safety information from different sources to determine whether a signal qualifies as a risk.
• Lead risk management activities for assigned products globally and contribute to the preparation of Risk Management Plans (RMPs), REMS, design of additional risk minimization measures as well as management of these plans throughout the product’s lifecycle. The Safety Physician is responsible to define the important identified risks, important potential risks, and the missing information.
• Represent PV in 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 and maintenance of CCSI.
• Provide PV support and safety contributions to Health Authority submissions (MAA/NDA/BLA submissions) and responses. Support global launch activities for assigned products.
• Collaborate with different functional stakeholders in Teva (Medical Affairs, Clinical Development, Quality, etc.) as well as outside Teva (KOLs, CROs, etc.) effectively representing PV position on any safety concerns as well as the overall safety profile of assigned products.
• Guide, provide support, and train, as applicable, safety physicians and safety scientists across safety surveillance activities such as medical review, signal detection, and risk evaluation activities.
• Perform due diligence on product safety profile of potential new assets.

• MD degree or equivalent
• General practitioner license; certification/background in neurology is a plus
• 3 years of minimum working experience in pharmacovigilance and drug safety area as a safety physician with
  • Experience in managing safety issues in pre- or post-marketing environment.
  • Proven abilities on handing safety surveillance tasks and chairing safety committee meetings.
• Experience in drug development is a plus
• Strong knowledge of FDA and EMA regulations (GVP, GCP)
• Experience with NDA/BLA submissions in the US and MAA in Europe is a plus
• Experience in managing safety due diligence of pharmaceuticals is a plus
• 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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