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Branka Aleksic

Branka Aleksic

Self Employed

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location of Branka AleksicSerbia

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  • Timeline

  • About me

    Pharmacovigilance Officer | Team Leader | Drug Safety Monitoring | Case Management (CT and PM)

  • Education

    • Faculty of Chemistry, University of Belgrade

      2003 - 2012
      Bachelor's degree Analytical Chemistry

      Competences- Fundamental and practical knowledge in various fields of chemistry, enabling the understanding of chemical processes and trained to actively participate in scientific research in the field of fundamental and applied research - Detailed knowledge of the mechanisms of chemical reactions and synthesis of modern techniques and modern instrumental methods, and the application of computational methods in data analysis - The organization of independent and creative work in… Show more Competences- Fundamental and practical knowledge in various fields of chemistry, enabling the understanding of chemical processes and trained to actively participate in scientific research in the field of fundamental and applied research - Detailed knowledge of the mechanisms of chemical reactions and synthesis of modern techniques and modern instrumental methods, and the application of computational methods in data analysis - The organization of independent and creative work in chemical laboratories with different profiles and purposes (research and development, quality control, standardization, process monitoring, etc.) - Qualified to participate in fundamental research and development projects and tasks is Show less

    • School of Chemical and Food Technology

      1999 - 2003
      Chemical technician

      Competences- Preparation and organization of work in the laboratory and group work in chemical plant- Production of chemical products Performance of sampling of raw materials, semi-finished products of the chemical industry- Implementation of safety measures and environmental Proper handling of chemicals- Monitoring the shelf life of raw materials and finished products- Exercising control of packaging and storage conditions of raw materials and finished products- The… Show more Competences- Preparation and organization of work in the laboratory and group work in chemical plant- Production of chemical products Performance of sampling of raw materials, semi-finished products of the chemical industry- Implementation of safety measures and environmental Proper handling of chemicals- Monitoring the shelf life of raw materials and finished products- Exercising control of packaging and storage conditions of raw materials and finished products- The measurement parameter / parameters of the technological process of production- Active participation in the chemical and scientific - research institutions- Keeping records of the quantity and quality of products- Measurement and regulation of production parameters and documentation on them Show less

  • Experience

    • Self-employed

      Jun 2017 - Jan 2018
      Self Employed

    • PrimeVigilance

      Jan 2020 - Jan 2024

      Providing support to other activities undertaken by the project team on behalf of the client and the company • Line Manages assigned ICSR staff • Creates and maintains project specific KPIs for contracted ICSR activities (this includes optimizing procedures, trainings and any other actions to increase ICSR team efficiency) • Proposes process changes to ICSR Operational Lead • Manages ICSR deviations with ICSR Operational Lead support • Reviews trackers and timesheet data and ensures accuracy • Is involved in ICSR processing and 2nd QC of cases Support other departments, as approved and instructed by ICSR Operational Lead • Supporting the RA & PV Network Department as needed, including acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager Show less Providing support to other activities undertaken by the project team on behalf of the client and the company Performing activities in the scope of ICSR management unit within agreed extent and timeframe (including, but not limited to): • Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines • Performing ICSR follow up • SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review) • Reconciliation (clinical, partners) • Personal data protection • Product Quality Complaint handling and interaction with Quality Assurance • Medical Information interaction • MedDRA and WHO coding • Database Outputs and Reports (including data for monthly reporting to clients) • Workflow & resource management • Mentoring and training of new and more junior employees within the departmentSupport of PV processes related to the ICSR management within PrimeVigilance and also to clients • Performing activities in the scope of ICSR management unit within agreed extent and timeframe • Supporting the RA & PV Network Department as needed, including acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager Show less • Providing support to other activities undertaken by the project team on behalf of the client and the company • Performing activities in the scope of ICSR management unit within agreed extent and timeframe (including, but not limited to): • Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines • Performing ICSR follow up • SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review) • Reconciliation (clinical, partners) • Personal data protection • Product Quality Complaint handling and interaction with Quality Assurance • Medical Information interaction • MedDRA and WHO coding • Database Outputs and Reports (including data for monthly reporting to clients) • Workflow & resource management • Support of PV processes related to the ICSR management within PrimeVigilance and also to clients • Performing activities in the scope of ICSR management unit within agreed extent and timeframe • Supporting the RA & PV Network Department as needed, including acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager Show less Providing support to other activities undertaken by the project team on behalf of the client and the company • Performing activities in the scope of ICSR management unit within the agreed extent and timeframe (including, but not limited to): • Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines • Performing ICSR follow up • SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review) • Reconciliation (clinical, partners) • Personal data protection • Product Quality Complaint handling and interaction with Quality Assurance • Medical Information interaction • MedDRA and WHO coding Support of PV processes related to the ICSR management within PrimeVigilance and also to clients • Performing activities in the scope of ICSR management unit within agreed extent and timeframe • Supporting the RA & PV Network Department as needed, including acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager Show less

      • PV Officer - Team Leader

        Jan 2023 - Jan 2024

      • Junior PV Officer /ICSR Management

        Apr 2022 - Jan 2023

      • Senior PV Associate /ICSR Management

        Apr 2021 - Apr 2022

      • PV Associate /ICSR Management

        Jan 2020 - Apr 2021

  • Licenses & Certifications

    • Project Management Foundations: Communication

      LinkedIn
      Aug 2024