Paulina Kasprzyk Email and Phone Number

🔹Process adverse event (AE) reports in compliance with global regulatory requirements, standard operating procedures (SOPs), and internal guidelines, ensuring high-quality data entry in the Argus Safety database.🔹Mentor newly onboarded and cross-functional staff by reviewing their processed AE reports and delivering hands-on training and shadowing sessions. Monitored progress through weekly metrics and provided constructive feedback to support their development.🔹Participate in audit and inspection readiness activities including leading internal process reviews to ensure compliance with SOPs. Collaborate within continuous improvement team to optimize department workflows. Present findings on non-compliance and areas for improvement to process owners and management.

🔹Process adverse event (AE) reports in compliance with global regulatory requirements, standard operating procedures (SOPs), and internal guidelines, ensuring high-quality data entry in the Argus Safety database.🔹Mentor newly onboarded and cross-functional staff by reviewing their processed AE reports and delivering hands-on training and shadowing sessions. Monitored progress through weekly metrics and provided constructive feedback to support their development.🔹Participate in audit and inspection readiness activities including leading internal process reviews to ensure compliance with SOPs. Collaborate within continuous improvement team to optimize department workflows. Present findings on non-compliance and areas for improvement to process owners and management.

🔹Processed adverse events reports according to applicable regulatory requirements, SOPs, protocols, and guidelines.🔹Performed data entry in Argus Safety database while assuring quality, compliance and consistency of all steps of AE processing.🔹Contributed to the implementation of new IT tools to support reporting processes, providing feedback to enhance system functionality.🔹Engaged in internal initiatives aimed at improving operational efficiency within the pharmacovigilance team.

🔹Processed AE reports, including follow-up activities in line with local and EU regulations.🔹Submitted processed reports via EudraVigilance web application (EVWEB) ensuring timely and accurate submissions.🔹Handled the intake of adverse event reports through a dedicated phone line.