Kameliya Dimitrova

Experience

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  PPD

  Jul 2014 - Jan 2016

  Drug Safety Administrator

  Pharmacovigilance Department• Provide SAE processing distribution to the Pharmacovigilance Department for global clinical trials• Work to ensure quality of information and documentation received from clinical sites are following ICH/ GCP. Process documentation using project specific/SOP guidelines. Guarantee timeliness of client deliverables are achieved• Perform high volume data entry of site specific information from SAE report forms into various safety databases as well as tracking databases. Entry of adverse events into project specific tracking databases.• Participate in high volume quality control of casebooks, report generation and distribution, project file creation and maintenance for assigned studies in electronic format. Prepare daily reconciliation reports • Assist in the audit readiness process for assigned studies and with preparation of materials for internal and Client audits. • Record project data into electronic imaging system and provide quality control of scanned documents• Responsible for adhering to corporate policies and SOPs/WPDs • Complete project start up and close out activities including archival of documents. • Participate in the PVG bidding process from Phase I and II-IV and utilize various bidding tools and applications Show less

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  Covance

  Jan 2016 - May 2017

  Drug Safety Assistant

  PV&DSS Department• Assist, assess and complete the processing of all adverse event reports received from any source. • Produce queries of safety data for clients.• Collaborate with Data Management and clients on reconciliation of safety databases and provide input for status reports.• Maintain adverse event tracking systems, project files, core process files and central safety files.• Perform eTMF/TMF filing and participate in audit preparation reconciliations.• Process SUSARs submissions to Investigators, ECs, etc.• Perform EudraVigilance reporting of SUSARs• Assist with the set-up of, and the provision of data to Safety Committees/DSMBs. Show less

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  ICON plc

  Jun 2017 - Jan 2021

  Drug Safety Associate

  Safety Reporting Group• Prepare regulatory documentation packets and coordinate the timely completion and submission of required reports to Health Authorities, Ethic Committees, Principal Investigators and business partners.• Ensure compliance with regulatory reporting requirements for safety reporting in Clinical Trials.• Ensure all Company, Sponsor, and regulatory timeframes are met for the reporting of safety information.

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  GW Pharmaceuticals plc

  Mar 2021 - Mar 2022

  Senior Associate, Clinical & PV QA Specialist
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  Jazz Pharmaceuticals

  Mar 2022 - now

  Manager, R&D Audits and Inspections