Elena NIKOLI

Experience

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  PAPASTERGIOPOULOS TRANSLATION SERVICES

  Sept 2006 - May 2008

  Freelance Translator
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  Mediterranean College

  Apr 2008 - Aug 2021

  FREELANCE TRANSLATOR
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  Ipsen

  Apr 2008 - now

  - MI and PV officer: maintain a comprehensive, accurate and timely medical information service to external and internal customers in line with industry standards. Develop and maintain a thorough knowledge of internal and external medical information systems and sources. Prepare and maintain all medical information standard letters and Q&As for assigned product(s) Assist in the administration of the Ipsen medical information document and enquiry management system Overview of the PCC vendor and communication with Global PCC team for any outstanding items. Run quarterly a medical information reportManage data and procedures related to Pharmacovigilance including but not limited to Identification, logging and submission of Adverse Events (AEs) to Global Patient Safety within Regulatory timelines and Company procedures, SOP gap analysis reviews and updateConduct Reconciliation with PQC, MI, 3rd parties Provide monthly PV reporting to GPSActive role in the preparation and conduct of PV audits and inspections. Collaboration with Ipsen Global Safety and oversight of PV vendors and partners Grants and Donations role.Own the flow and execution of grants and donations process. Build and lead the related correspondence and interactions with all stakeholders a proper roll out of the process in full compliance with corporate and local standards -Ethical and Admin Activities: Build and check compliance of the contracts under Medical Department’s responsibility and ensures all corporate and local standards are respected. Ensures the execution and compliance of administrative documentation for the approval of theprotocols in compliance with corporate and local standards and processes. Support related to the implementation of Medical projects/activities in close collaboration with Medical Director and MSLs including and not limited to contractual agreement preparation, budget overview and amount commitments, communication with suppliers, Due Diligence process etc. Show less OverviewCollaboration with Medical Director for effective and efficient medical project organization such as disease awareness campaigns, patient centricity projects.Work proactively ensuring always delivering on time and accurately managing workload; ensuring all working relationships are well managed and receive the highest level of attention and support. Medical Information Lead for Greece with wide range of duties.Medical Information Lead - Medical Information Requests Reception and Handling. - Literature search for MedInfo Requests (Embase, clinicaltrials.gov etc)- Input of MIR (including Product Complaints & Adverse Events) into IPSEN's medical Information system (MISTRAL Tool- Medical Information System for Tracking, Repository and Logging)- Preparing draft responses for patient compliments and complaints- Transfer of PQCs and AEs to Quality Dpt and Global Patient Safety - Prepare standard operation procedures for Medical DepartmentPharmacovigilance associateSupport LQPPV in all PV Activities such as Adverse Event Reporting and FUs, monthly reportings, reconciliations etc. Show less

  • Medical Affairs and MI Officer LCPPV Deputy

    Aug 2021 - now

  • Medical Assistant & Office Coordinator

    Feb 2018 - Aug 2021

  • Global Hyper Care Liaison(assignment to IPSEN GMI)

    Dec 2020 - Jun 2021

  • Personal Assistant to Marketing & Sales Manager

    Apr 2008 - Jan 2018