Ewa Kozikowska-Prusaczyk Email & Phone Number

Warszawa, Woj. Mazowieckie, Polska

Co-leading of global aggregate process – planning, managing, and monitoring correct preparation of Periodic Safety Reports (eg. Periodic Safety Update Reports, Addendum to Clinical Overview, SUSAR Reports) supporting the process adjustment to Emergency Use Authorization (EUA)Independently ensures quality, compliance, and consistency of all steps of AE processing activities (case management) and coordinates and performs quality and compliance related processes and tasks.Responsible for analyzing, triaging, reviewing and processing of all adverse experience information received for investigational and marketed products, according to standard operating procedures for further reporting to worldwide regulatory agencies by Global Pharmacovigilance.Developed PV knowledge by participating in internal/external trainings and by self-learning.Leading or participating in additional non-standard projects or pilot programs.Supports implementation and use of new technologies and solutions.Serves as a Point of Contact, providing feedback and support to ensure resources are updated appropriately to enable quality and compliance of AE reports. Stays abreast of updates to act as resource for questions/clarifications.Shares PV knowledge and expertise with PV team, other departments and Customers, actively promotes Safety rules and awerness.

Perform compliance monitoring and provide support to the local team for compliance related matters.Acts as a mentor and trainer for new PV employees (Compliance training/mentoring).Identifies, prioritizes, and monitors quality issues to be resolved to maintain compliance.Monitor, verify the data entry criteria and assess the validity of adverse reaction reports as Non-Valid and Reject Assessor.Perform monthly summaries and assists during CAPA processing for NVR process. Supports implementation and use of new technologies and solutions.Effectively communicates with internal and external stakeholders, participates in internal and external team meetings.

Receive and process adverse event (AE) reports and other information related with adverse events of medicinal products and medical devices according to applicable regulatory requirements, SOPs, protocol and guidelines (marketed reports, solicited reports, medical device reports, literature reports).Performed review, analysis, triage and filing of AE information within established timeframes.Ensured quality, compliance and consistency of all steps of AE processing activities (case management).Contributed to overall compliance with departmental goals and objectives.Develop PV knowledge by participating in internal/external trainings and by self-learning.Effectively communicated with internal and external stakeholders, participated in internal and external team meetings

Warszawa, Woj. Mazowieckie, Polska

Supervising the proper functioning of the pharmacy.Solving problems with legal interpretation of pharmaceutical law. Checking prescriptions in formal terms and preparing reimbursement statements.Dispensing medications and focus on safety and effectiveness of prescribed drugs.