Agata Gesiewicz

Experience

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  University College Dublin

  Oct 2011 - Feb 2012

  Assistant Research Scientist

  Title of the project: Protein carbohydrate interactions in the pathophysiology of asthma: the purification of mucins;Analysed sputum samples collected from asthmatic patients;Maintained documents, interpreted research results, optimized experimental procedures and solved any problems arose during study;Presented and discussed research outcomes during meetings of members of the project to improve procedures effectiveness;Worked as a team leader: trained a group of students who joined the project, controlled and supervised their work, verified and analysed their progress. Show less

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  Science pharma

  May 2012 - Jan 2013

  Clinical Research Associate

  Performed initiation, study staff training, interim monitoring and close-out visits for two bioequivalence studies;Reviewed and edited clinical trial related documentation including but not limited to: Case Report Forms, Informed Consent Forms, Study Protocol, Investigators brochure;Performed source document verification, retrieved case report forms and performed query resolution in a timely manner;Prepared registration modules: 2, 4 and 5 of the eCTD;Assisted in the preparation of Summary of the Product Characteristics and Patient Information Leaflets; Show less

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  Polpharma

  Jan 2013 - Jan 2014

  Junior Periodic Reporting Specialist

  Prepared and submitted Periodic Safety Update Reports, Addendum to Clinical Overviews, and Periodic Benefit-Risk Evaluation Reports to the Agencies;Conducted literature search, reviewed, assessed and made the decisions for report ability;Reported adverse drug reactions: assessed the seriousness, coded the event per the MedDRA terminology, labelled the events per the Company Core Safety Information;Archived documents per prevailing standards

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  Polpharma

  Mar 2014 - Jan 2019

  Preparation and negotiation of pharmacovigilance agreements with business partnersManagement of safety agreements and RMP databasesManaged the risk management systemSet-up and implemented measures to assess the compliance rate and effectiveness of the risk minimisation measuresPrepared and evaluated all the documents required within the risk management systemPrepared and implemented educational materials for healthcare professionals and patients associated with additional risk minimisation measures Show less

  • Senior Pharmacovigilance and Risk Management Specialist

    Apr 2017 - Jan 2019

  • Periodic Safety Update Report Specialist

    Mar 2014 - Mar 2017
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  Lambda Therapeutic Research

  Feb 2019 - now

  EU QPPV, Senior manager

  Acts in compliance with Regulation (EU) No. 1235/2010 & 520/2012, Directive 2001/83/EC & 2010/84/EU, Applicable National Laws and EMA‘s Guideline on Good Pharmacovigilance Practices (GVP) and in accordance with the MAH’s Procedures.Establishment, maintenance and management of the MAH's pharmacovigilance system.Oversees functioning of pharmacovigilance system in all relevant aspects including its quality system.Ensures that all pharmacovigilance activities within the EU are covered by appropriate procedures, which fully explain the processes and are in accordance with relevant regulations.Maintains an overview of the safety profiles and any emerging safety concerns in relation to the MAH's medicinal products authorization.Having awareness of any conditions or obligations adopted as part of the marketing authorisation and other commitments relating to safety or the safe use of the product including risk minimisation measures.Being aware of and having sufficient authority over the content of RMPs, aggregate reports, PASS.Oversees on-going evaluation of the MAH's authorised products, by signal detection and evaluation.Ensures submission compliance of pharmacovigilance related reports with necessary quality that includes the correctness and completeness of reporting.Oversees preparation and maintenance of PSMF in order to promote, maintain and improve compliance with the EU legal requirements.Acts as a single contact point for MAH and the competent authorities with 24/7 availability.Oversees local QPPVs/LRPs activities.Liaises with competent authorities/agencies in Member States for the provision of additional information necessary for the benefit-risk evaluation of a medicinal product.Manages/provides support for inspections conducted by regulatory authorities.Acts as manager, responsible for leadership and supervision of the team. Show less