Elissavet Moutesidi

Experience

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  REA Maternity Hospital

  Aug 2013 - Dec 2013

  Trainee Embryologist
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  Health Data Specialists Ltd

  Oct 2014 - Aug 2018

  -Manages Competent Authority / National Ethics Committee/ Hospital IEC applications and approvals -Oversees international clinical trials regulatory submissions in liaison with local teams.-Assists in maintenance, training and record keeping Clinical SOPs and guidelines as per GCP, ICH, and EMA Guidelines.-Collaborates with medical dpt. for the review of master ICFs and ensures adaptation of local ICFs as per applicable regulations.-Coordinates the set-up, review, and approval of clinical trial agreements, etc in order to ensure timely clinical trial start and compliance to the applicable local legislation.-Files and collates trial documentation-Provides accurate updates on all outstanding contractual documents to Management as required-Provides support for activities with outside vendors and business partners, as required such as service agreements and work orders review, tracking and reporting the expenses against the budget. Show less Job Description:-Ensuring the implementation of project plans as assigned. -Responsible for regulatory submissions, including management of study contracts of YPE/Universities & private physicians, as required.-Train & instruct study site personnel, organizing study site initiation. -Site management, monitoring, remote monitoring & closure, according to Company’s or Sponsor’s -Standard Operating Procedures, GCP/ICH Guidelines and applicable legislation. -Evaluation, forecasting & management of patient recruitment vs. agreed target.-Filing & collating study documentation and reports.-Determine & arrange payments in collaboration with Study Manager.-Participation in study specific meetings to review progress & provide feedback to study manager.Fields of expertise in study conduct:-Autoimmune diseases (Rheumatoid Arthritis)-Neurology (Multiple Sclerosis)-Fungal Infections (Invasive Candidiasis)-Metabolism (Dyslipidemia)-Hematology/Oncology (Multiple Myeloma)-Urology Show less

  • Clinical Submissions and Contracts Officer

    May 2017 - Aug 2018

  • Clinical Research Associate

    Oct 2014 - May 2017
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  Pharmathen

  Sept 2018 - Sept 2023

  - Adopts, implements and oversees the efficient maintenance of the PV Quality Management System.- Compiles/ Contributes to the compilation of SOPs and other quality-controlled documents.- Analyses KPIs to identify areas for which process improvement or revision of controlled docu-ments & training requirements are necessary.- Handles investigation and follow up of identified non-compliances & quality issues.- Evaluates & reviews PV Audit/Inspection findings, develops corrective and preventive action plans and keeps track of their effective implementation.- Hosts Authority PV Inspections & Pharmacovigilance audits by partners/clients.- Prepares PV Audit plans and conducts periodic & for cause Audits to contractual partners i.e. distributors, vendors.- Acts as Project Manager in various activities (e.g., aRMMs implementation, new computerized systems vendors selection).- Supports the drafting, negotiation and implementation of new/updated PV agreements.- Prepares Periodic Reports for Upper Management.- Compiles PV dept. annual training plan & trains relevant stakeholders on PV requirements and/or company’s PV-related SOPs.- Updates the Pharmacovigilance System Master File.- Maintains awareness of global PV and clinical regulations.- Reviews Safety Part of Clinical Trial Protocols.- Reviews Risk Management Plans.- Monitors Authority safety announcements & supports the regulatory intelligence function Show less

  • Pharmacovigilance Senior Team Leader

    Dec 2022 - Sept 2023

  • Pharmacovigilance Compliance Senior Officer

    Jul 2022 - Jan 2023

  • Pharmacovigilance Compliance Officer

    Sept 2018 - Jul 2022
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  Creative Pharma & HR Services

  Aug 2023 - now

  Vigilance Manager