Experience

• 

  Institute of biochemistry and biophysics pan

  Jan 2005 - Jan 2006

  Research fellow
• 

  The office for registration of medicinal products, medical devices and biocidal products

  Jan 2006 - Jan 2007

  Specialist in central registry of clinical trials department
• 

  Pfizer

  Jan 2007 - Jan 2011

   Organize, manage and carry out local pharmacovigilance activities, such as adverse event monitoring, safety reporting, risk management, local safety monitoring activities as required by local agency, process documentation and training, inspection preparedness Perform Individual Case Safety Reports (ICSRs) case processing Determine and conduct follow up activities for clinical and spontaneous cases Submit individual expedited case reports within regulatory required timelines and timely delivery of information for aggregate reports and other regulatory documents as requested Perform quality check of processed cases to verify accuracy, consistency and compliance with process requirements Show less

  • Senior Safety Officer

    Jan 2010 - Jan 2011

  • Safety Officer

    Jan 2007 - Jan 2010
• 

  Pfizer

  Oct 2012 - now

   Provide oversight needed to ensure high quality performance of country organization  Promote quality management, compliance, inspection readiness, training and process improvements Coordinate and support local audits and inspections including management of corrective and preventative actions  Manage quality review activities (plan, conduct, report, follow up) Develop, implement and maintain of local Quality Management Systems; oversee local procedures and training management; cascade and implement global rocedures to local organization  FCPA Compliance Champion Work in cross-functional environment Show less  Mentor Medical Quality and Compliance Managers (MQCMs) in Hungary, Czech, Slovakia, Croatia, Israel, Latvia, Estonia, Lithuania, Poland Provide audit and inspection related support in assigned countries Provide guidance on Country Quality Plan: development, maintenance and closure Monitor MQCMs progress fulfilling the commitments identified in the Country Quality Plan Lead/participate in above country projects i.e. development of standardized documents for countries, member of training curricula steering committees, coordination quality review activities across Emerging Markets countries, inspection readiness workshops  Play Point of Contact role for global/regional SOPs Collaborate with different global lines i.e Regulatory, Medical Affairs, Medical Quality, Safety, Medical Information Show less

  • Director, Global Commercial Quality Oversight

    Nov 2019 - now

  • Global Medical Quality Oversight and Analytics Director - CEP/CIT

    Dec 2016 - Nov 2019

  • Cluster Medical Quality Oversight Manager

    Apr 2014 - Dec 2016

  • Medical Quality and Compliance Manager Poland

    Jun 2011 - Nov 2014

  • Customer Engagement Program Secondment, Emerging Markets& Established Products

    Sept 2013 - Mar 2014

  • Emerging Markets Medical Quality and Compliance Secondment

    Oct 2012 - Mar 2014