Dániel Ősz

o Implementation and maintenance of relevant processes

o Administration of relevant computerized systems

o To organize in preparation and participation in regular Quality review meetings

o Participation in relevant self-inspections and global Quality audits

o Presentation of topics within own responsibility

o Management of Change Controls and Events and CAPAs on the perimeter of the Quality System

o Support Fast Moving Consumer Health with agile activities to implement new technologies, products

o Ensure Quality over the whole department within External Manufacturing Consumer Healthcare Europe and LATAM (EULA).

· Supports the development, implementation and maintenance of the Quality System in support of 10 GDP Quality, including the EU based legal entities, Global GDP sites and transportation according to Regulatory and Pfizer Quality Standards requirements

· Supports to identify training requirements of core quality processes in 10 GDP operations

· Supports the regulatory inspections and audits for GDP at the EU based GDP Legal Entities and 10 GDP sites

· Support to implement proper inspection/audit response with defined Corrective Actions/Preventive Actions and Commitments to GDP Board of Health and RQA audit findings

· Supports to ensure that 10 GDP Site Internal Audit program is executed against that program

· Performs Site Internal Audit according to the audit program

· Carry out case processing activities in Argus

· Review, rank, verify, process and document case-related information. Process cases based on these assessments

· Review case criteria to determine appropriate workflow for case processing

· Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately

· Liaise with key partners, locally, and other stakeholders regarding safety data collection and data reconciliation

· Write and edit case narrative

· Determine and perform appropriate case follow-up, including generation of follow- up requests

· Determine reportability of scheduled reports, ensuring adherence to regulatory requirements

· Ensuring that Field Safety Corrective Actions are reported immediately to each Competent Authority in the territory from which any In Vitro Diagnostic recall is made with requirements and timeline according to European and local Regulations.

· Taking Potential Reportable Event local decisions based on local regulation in case of incidents and to report these in the available tools (AER module).

· Ensuring that incidents are reported immediately to the national Competent Authority in case of any complaints occur in line with all requirements and timeline according to European and local Regulations.

· Ensuring that accurate answers are provided to the national Competent Authority on a timely manner.

· Communicating with Competent Authorities, customers, third parties regarding regulatory compliance as needed.

· Implementing local procedures and local Vigilance trainings taking into account Corporate, local and European regulations and requirements.

· Reporting to General Manager (functionally) and to Quality Leader (operational reporting) the local performance indicators on Vigilance and FSCA reporting.

· Evaluating the change of process, tool and corporate or regional procedures on the local process and documentation.

· daily use of CRM system to manage service reports in a timely manner (KPI) and ensure customer satisfaction

· Handling Medical Information questions

· Database management (PRIMA, MS Access)

· Handling incoming potential adverse events and product complaints to relevant departments (triage)

· Event management, organizer Country Medical Council meetings

· Vendor contract management

· Daily communication with Health care professionals (MD, GP, PharmD)

· Provide scientific materials, publication

· Invoicing, used Ariba system for Purchase Order creation (Ariba P2P, SAP)

· Medical Information trainings for Medical Advisor colleagues

· Daily cooperation with Medical Advisor team and other departments

· Participation in internal and external audits, authority inspections