Tea Borojević

Experience

• 

  Paraiso mediterraneo

  May 2015 - Jun 2015

  Tour Operator
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  Faculty of chemical engineering and technology

  Feb 2016 - Jun 2019

  Student Assistant
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  PLIVA

  Jul 2016 - Aug 2016

  Studentska praksa
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  Boehringer Ingelheim

  May 2017 - Sept 2019

  Student Office Assistant
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  PrimeVigilance Ltd.

  Oct 2019 - May 2021

  Pharmacovigilance Associate

  · Processing Individual Case Safety Reports (ICSRs) including literature, post-authorization, post-marketed (spontaneous), regulatory authority and clinical sources· Tracking, booking, filing and archiving ICSRs· Translating source documents if needed· Performing duplicate check and triage· Performing data entry of adverse event case reports into the safety databases (ARISg, Argus and projects specific databases)· MedDRA coding of the adverse events· Performing seriousness, listedness and expectedness assessment· Performing reportability assessment against requirements for each country· Follow-up ICSRs with the reporter· Participation in inspections and audits· Perform ICSR reconciliation with business partner· Line Managing responsibilities inside the Project Team· Performing local scientific literature and national safety web portal monitoring for adverse event reports and other safety information in line with the applicable controlled written procedures of PrimeVigilance and client specific arrangements.· Formulation and/or adjustment of the search strategy: selection of search terms and identification of all applicable local equivalents· Documenting the local sources and the search query in the Search Set-up Form Show less

• 

  Optimapharm

  May 2021 - now

  • Identify and plan nature and scope of the ethics and regulatory submissions services, including periodic or local safety reporting as applicable, being contracted from the Sponsor/Client for submission of clinical studies and non-interventional studies• Propose submission strategy and agree with Sponsor/Client representatives format for submission components and timelines for deliverables to OPTIMAPHARM, to the Sponsor, and to the ethics committees and/or regulatory authorities;• Drafts and reviews project plans (on assigned projects) that are impacting functional group, including Startup and Site activation processes, Regulatory submissions, Translations, Contract management, ICF management, Communications and TMF;• Participates in company regulatory intelligence efforts, by review of the relevant websites/guidelines on a regular basis, Identify changes in legislation or guidelines, assessment of impact on Quality Systems and the departmental functionality, escalation to senior management / appropriate personnel;• Coordinate regulatory requirements collection, collation and tracking for further Department and Company utilization• Where preparation of the subject Informed Consent documents is OPTIMAPHARM’s responsibility, ensure that documentation is prepared in compliance with the applicable SOPs, European guidelinesand local regulatory requirements• Serve as key Client contact for assigned project(s) during start-up phase of the project;• Negotiates budget and contract with site and with Sponsor/Client until resolution of issues and contract execution.• Responsible for preparing and reviewing essential documents required for the Investigational Medicinal Product or Investigational Medical Device release to the investigational sites (compilation of GLP)• May act as EU CTIS Preparer/Reviewer, as assigned; Show less • Prepare clinical trial submission dossiers for Regulatory and Ethics Authorities;•Identify nature and scope of the ethics and regulatory submissions services, including periodic or local safety reporting as applicable, being contracted from the Sponsor/Client for submission• Propose submission strategy and agree with Sponsor/Client representatives format for submission components and timelines for deliverables to OPTIMAPHARM, to the Sponsor, and to the ethicscommittees and/or regulatory authorities;• Ensure the proper completion of all necessary application, registration, certification, and/or other documents that are to be included in the ethics and/or regulatory submission;• Perform quality control of the submission components assembled and check the accuracy of the opinions and/or approvals issued by ethics committees and regulatory authorities ensure that documentation is prepared in compliance with the applicable SOPs, European guidelines and local regulatory requirements and that appropriate and accurate translations to, and back translations from, the local language are provided;• Serve as key Client contact for assigned countries within the project(s) during start-up phase of the project;• May act as EU CTIS Preparer/Reviewer, as assigned; Show less

  • Regulatory and Startup Manager

    Apr 2023 - now

  • Regulatory and Startup Specialist II

    Jan 2023 - Apr 2023

  • Regulatory and Startup Specialist I

    Apr 2022 - Jan 2023

  • Regulatory Officer

    May 2021 - Mar 2022