Panos Katsaris Email & Phone Number

Athens, Greece

Eu Emea

Quality consulting services to Pharma companies on Pharmacovigilance with efficiency and cost-effectiveness focusing on experience, quality, flexibility and customer satisfaction.GMP needs, EU QPPV, PSUR, Signal Detection, Local Literature ScreeningDossier projectClinical reviewReadability testingand more!

Athens, Attiki, Greece

Athens, Greece - Dublin Ireland

Athens, Greece

Supervision of reporting requirements and timelines for case reports and PSUR;Supervision of correct quality of ICSR and PSUR;Supervision of audit results and tracking of corrective actions.Global SOPs;Establishment and maintenance of the ADR data base;Collection and collation of every PhV related information;Reporting of ICSRs and PSURs to local authorities and EU authorities;Improvement of risk-benefit balance;Withdrawal procedures;Co-ordination and supervision of responses to competent authorities;Supervision of all obligations resulting from Risk Management Plans.

Athens Greece

 Part of a team of 10 persons Quality complaints handling Product Technical Specifications preparation CAPA handling & Audit coordination

Athens Greece

Part of a team of 3 persons and directly reporting to the Head of EU Scientific AffairsTransition of the company’s Pharmacovigilance System (PVSYS) to the Pharmacovigilance Site Master File (PSMF) along with review of the Standard Operation Procedures (SOPs) in order to depict the new GVP Modules. This project involved co-ordination of various departments within the company and also direct co-ordination with the National Organization for Medicines and the European Medicines Agency (EMA). Also in strict contact with company’s partners regarding the exchange of safety informationLeading trainer for pharmacovigilance applying to all company’s personnel.Handling of incoming Adverse Event Reports (ADRs), Eudravigilance registration, literature monitoring, Periodic Safety Update Reports (PSURs) preparation & submission, Risk Management Plans (RMPs) and Safety SignalsCo-operation with the Medical department regarding medicinal information and trainingHead of the audit team and CAPA implementation and follow up proceduresTransition into Watson (2011)Co-ordinator for the transition to the Watson PSMF after merging of companiesSOP projects team co-ordinator (team of 2 local persons and a team of 8-10 on worldwide basis)RMP projects team leader (team of 2 local persons and a team of 8-10 on worldwide basis)Quality AssuranceCoordination of Technical & Quality Agreements. Reporting to the QS/QA Manager

Supervision of reporting requirements and timelines for case reports and PSUR;Supervision of correct quality of ICSR and PSUR;Supervision of audit results and tracking of corrective actions.Global SOPs;Establishment and maintenance of the ADR data base;Collection and collation of every PhV related information;Reporting of ICSRs and PSURs to local authorities and EU authorities;Improvement of risk-benefit balance;Withdrawal procedures;Co-ordination and supervision of responses to competent authorities;Supervision of all obligations resulting from Risk Management Plans.

Marketing planning within Greek , Italian and Cyprus market. International Exibitions' planning.

Responsible for the good operational status of the Drug Store. Health advice to customers and co-operation with MDs and other health professionals.

Msc, Pharmacy

Master, Mba - Healthcare Management

Activities and Societies: MBA Students Association President 2008 - 2010