Lucija Kovačec

- Leading the team and the Daily workload meetings - Oversight of the workload/absences - Raising issues to the managers - Keeping oversight of the projects - Safety management plan review - Process improvements - Product/substance registrations to the EMA - Supporting the managers - Communicating with Sponsors - Training of new team members - Presenting new/complex topics to the internal team/other departments

- Leading the team and the Daily workload meetings - Oversight of the workload - Suggesting solutions to the complex topics - Managing deviations - Quality Check of the submission documents - Training of the new team members

- Collected and processed Serious Unexpected Suspected Adverse Reaction (SUSAR) reports - Interacted with investigative sites; coordinated and prioritised daily project specific safety surveillance duties - Oversight of submission of safety reports in the appropriate format to Competent Authorities/Ethics Committees in compliance with regulatory timelines - Performed data entry of events into the EudraVigilance portal - Drafted study specific safety documents as required

- Performed Quality review of clinical trial cases - Finalized clinical trial cases - Secured sending reports to regulatory agencies - Provided training and feedback for new team members

- Processed Individual Case Safety Reports (ICSRs), from all sources in compliance with applicable regulations, procedures, and per client-specific requirements and timelines - Executed Triage and Data Entry of different types of ICSRs - Performed local literature search in German