Walaa Aleliwi

Experience

• 

  Doctors Without Borders/Médecins Sans Frontières (MSF) Canada

  Jan 2014 - May 2014

  Medical Interpreter
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  Green Pharm Pharmacy

  Mar 2015 - Nov 2015

  Pharmacist Assistant
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  TELUS International Europe

  Mar 2016 - Dec 2017

  Subject Matter Expert
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  PPD

  Dec 2017 - Jul 2019

  Safety Specialist

  Work ExperienceDatesOccupation or position heldName of employerType of business or sectorMain activities and responsibilities 18-Dec-2017 – OngoingPharmacovigilance: Drug Safety SpecialistPPD BulgariaPharmaceutical• Responsible for adhering to SOPs/WPDs, and awareness of ICH GCP, EMA and FDA guidelines and other relevant global and local regulations. • Effectively interface with Project Management Teams, Client Companies affiliates, and Investigators regarding SAE activities.• Ensure any expedited safety reports are notified to applicable Regulatory Authorities, Ethics Committees and Principal Investigators within regulatory timelines.• Provide project specific safety training to PPD Clinical on assigned projects.• Responsible for coordinating and performing adverse event (SAE/AE) triage, data entry into PPD-owned or client provided adverse event safety database, review of entered cases for quality, consistency and accuracy, follow up with reporter and/or associated HCP, tracking of reports, and reporting activities.• Coding adverse event terms using MedDRA and narratives authoring according to client convention.• Assist with preparation and review of regulatory reports.• Review literature articles/abstracts and process adverse event reports from literature per program and regulatory requirements.• Maintain knowledge and understanding of PPD and client-provided SOPs and current local and global regulations.• Effectively communicate with team members, client contacts and adverse event reporters.• Prepare team monthly metrics.• Deviation writing and submitting to QA Department when necessary.• Involved in authoring of a client specific data entry guideline.• Conducting training for new starters, mentoring their performance and providing coaching sessions. Show less

• 

  Fortrea

  Jul 2019 - now

  • Provide leadership and management of global and regional projects ensuring that communications and processes are harmonized for assigned projects.• Monitor and manage the workflow for assigned projects to ensure all deadlines are met and compliant safety reporting in accordance with International reporting regulations, SOPs and safety processing guidelines set forth by departmental management team.• Execute and/or ensure routine quality review of adverse event reports and aggregate reports ensuring that case processing and data quality meet global regulatory compliance standards for assigned projects. • Maintain a strong understanding of client specific database conventions and system functionality. • Assist in the preparation of listings for Annual IND reports, PRs and PSURs and work with Data Management or client on reconciliation of safety databases.• Generate monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided.• Maintain a comprehensive understanding of SOPs, WIs, guidance documents and directives associated with safety management, reporting and pharmacovigilance.• Prepare Safety Management Plans (SMPs), Reconciliation Plans, and other safety-specific plans ensuring optimal efficiency. Provide oversight and preparation of timely pharmacovigilance reports for products and safety issues, including but not limited to ICSRs of SAEs and aggregate reporting• Monitor and manage project deliverables regarding contract assumptions, identifying out of scope work or potential to run over budget• Contribute to the generation and review of Time and Cost Estimates for Patient Safety Solutions business. Generate monthly status and other project-specific reports ensuring the quality and accuracy of metrics provided• Attend client and audit meetings as appropriate.• Manage the investigation of non-compliance and CAPAs including assessment of root cause and implementing corrective measures where required. Show less o Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to: o Entry of safety data onto adverse event database(s) and tracking systemso Review of adverse events for completeness, accuracy and appropriateness for expedited reportingo Write patient narratives and code adverse events accurately using MedDRAo Determine expectedness/listedness against appropriate labelo Identifies clinically significant information missing from initial reports and ensures its collectiono Prepare follow-up correspondence consulting the medical staff accordinglyo Reporting of endpoints to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelineso Participate in signal detection and trend and pattern recognition activities, as appropriate.o Prepare timely pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Eventso Assist in the preparation of listings for Annual IND reports, Periodic Reports (PRs) and Periodic Safety Update Reports (PSURs) and work with Data Management or client on reconciliation of safety databases.o Participate in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided.o Maintains a comprehensive understanding of Covance Safety’s Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.o Ensure compliant safety reporting in accordance with US and international reporting regulations, SOPs and safety processing guidelines set forth by departmental management team and the client. Show less

  • Patient Safety Project Manager

    Feb 2023 - now

  • Senior Drug Safety Associate

    Feb 2021 - Feb 2023

  • Drug Safety Associate

    Jul 2019 - Feb 2021