Director, Global Pharmacovigilance

Encontrado en: Talent ES C2 - hace 1 semana

Madrid, España Teva Pharmaceuticals A tiempo completo

The opportunity

As a Director, Global Pharmacovigilance - Neurology Safety Physician you will be part of the Global Pharmacovigilance (PV) and Medical Scientific Unit (MSU) supporting drug safety across the entire Teva portfolio and throughout the product lifecycle. 

You will lead activities necessary to determine the safety profile and the characterization, monitoring, and mitigation of risks of assigned products during clinical development and post marketing, including Company / Investigator Sponsored studies, Compassionate Use and Disease Monitoring Programs. 

How you’ll spend your day

Collaborate with other R&D 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 to present decisions from the Product Safety Group to senior safety governance committees as well as other forums attended by Teva Senior management Perform medical reviews and assessments of ICSRs for assigned products from clinical trials Take accountability 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 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 products 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 life cycle. Act as a key member for safety related label negotiations with regulatory agencies as well as in the development of internal CCSI Provide PV support and contribution to MAA/NDA/BLA submissions Guide, provide support and train PV scientists across safety surveillance activities such as: medical review, signal detection and risk evaluation activities Collaborate with different functions inernally (Medical Affairs, Clinical Development, Quality etc.) as well as external stakeholders (KOLs, CROs etc.) and effectively communicate the PV position on any safety concerns as well as the overall safety profile of assigned products Support global launch activities for assigned products Perform Signal detection / management related activities including PM AE review, literature review and Health Hazard Assessments as relevant. Perform due diligence on product safety profile of potential new assets, including early and late stage development assets

Your experience and qualifications

Medical Doctor / Physician or equivalent Completion of an accredited Residency / Specialty program - Neurology preferred Experience in drug development in neurology Proven experince working in pharmacovigilance and drug safety, as a safety physician with a significant portion of time devoted to supporting drug development activities (Phase 1 – 3) 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 ability handing safety surveillance tasks and chairing safety committee meetings Strong leadership capabilities and matrix management experience Ability to work cross-functionally with an international team across multiple time-zones Experience in managing safety due diligence of pharmaceuticals at varied stages of development Outstanding communication skills with an ability to collaborate with different departments and partner with and influence others without direct authority (this role comes with no direct line management responsibility)  Oral and written fluency in English 

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