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Curriculum Vitae (detailed edition) Panos K Katsaris Pharm. D, MBA
Personal Details
Date & Place of Birth:	September 11th 1976, Thessaloniki Greece (EU)
Postal Address:	82 Eptanisou str GR – 13231, Petroupoli, Athens – Greece
Mobile Phone:	+30 6945 783844
Home Phone:	+30 21 1118 4709
E-mail:	p.k.katsaris@gmail.com
Linkedin profile:	https://gr.linkedin.com/in/panoskatsaris
Educational Background
06.2010	MBA (Area of interest: Healthcare Management); “State University of New Hampshire (U.S)” - Hellenic American University/HAU (Athens - Greece)
02/2005	State Pharmacist’s License Diploma, “Universita’ di Ferrara (Italy E.U)” in accordance with the E.U Legislation & Hellenic Ministry of Health
10.2004	MSc Pharmacy, “Alma Mater di Bologna (Italy E.U)” - Specialization in Cosmetic & Galenic Preparations
Professional Background
Period	Position
05/2017-Current	EU QPPV Pharmafile Limited Dublin – Ireland & Athens - Greece
Current EU QPPV job description §  Set up and maintenance of the Pharmacovigilance database, SOPs, contractual arrangements, database operations, ensuring data compliance regarding quality, expedited reporting, periodic update reports, audit reports and staff training. Validation of adverse reaction databases and working with any relevant CAPAs. §  PSMF/ RMP/SDEA maintenance. §  Working with relevant regulatory departments to maintain and update SmPCs/product information when required as a result of newly identified safety information. §  Provide PV training §  Receipt and acknowledgement of ICSRs §  Submission of PRODUCT DATA and Summary of Product Characteristics (SmPC) to the eXtended EudraVigilance Medicinal Products Dictionary (XEVMPD) database §  Pharmacovigilance Safety Data Agreement [SDEA] handling §  PSMF/ RMP/SDEA maintenance. §  PSUR production. §  being involved in the review and sign-off of protocols of post-authorisation safety studies conducted in the EU or pursuant to a risk management plan agreed in the EU; §  ensuring the necessary quality, including the correctness and completeness, of pharmacovigilance data submitted to the competent authorities in Members States and the Agency; §  acting as a single pharmacovigilance contact point for the competent authorities in Member States and the Agency on a 24-hour basis and also as a contact point for pharmacovigilance inspections. . §  Recognising and forwarding Quality complaints to the QA Department and performing monthly reconciliations. §  Detection, assessment, understanding and communication of safety information, as well as risk management activities §  Overseeing the safety profiles of a client  company’s marketed products and any emerging safety concerns §  Acting as a single point of contact for the Regulatory Authorities on a 24-hour basis, and the §  Perform initial assessment of seriousness, expectedness, causality, and report ability. §  Prepare expedited reports for submission to regulatory authorities (E2B(R2)). §  Review product complaints and assess for potential adverse events or any impact on subject safety. §  Conduct literature review activities related to adverse event reporting. §  Contribute to the preparation of regulatory responses, Investigator’s Brochure (IBs), study protocols, case report form, safety reports, and other documents as required. §  Perform case investigation to gather all required medical information, including query generation, tracking, and follow up with reporters (research and post-market). §  Liaise with clinical operations, medical/drug information, regulatory affairs, clinical research organizations (CRO), study sites, affiliates, and data management groups regarding safety data collection and data reconciliation as required. §  Process literature searches (weekly), MLM, E2B cases received for MAH/ data base maintenance. §  Maintenance of product safety profiles and implementation of signals arising from risk-benefit evaluations
04/2013-02/2017	Local Safety Officer – Greece & Cyprus Teva – Specifar S.A. Athens - Greece
Brief Description Local Safety Officer – Greece & Cyprus Local Safety Officer – Greece & Cyprus and EU member countries. Also responsible for affiliate company with Marketing Authorizations in extra-EU countries including GCC countries and the Americas. Leading of a team of 2 persons and directly reporting to the corporate EU QPPV Leading 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 Signals Co-operation with the Medical department regarding: Medicinal information Medicinal assessment of incoming queries Risk Minimization Material production and implementation Medical literature research and translation Medical training Contact person for Healthcare Professionals (doctors, Pharmacists, Nurses etc.) Head of the audit team and CAPA implementation and follow up procedures Integration project Actavis + Specifar S.A. key person on Drug Safety Pharmacovigilance dept. organization and direction – liaise with corporate Actavis group of companies EU - Drug Safety dept. Medical representatives training both on scientific safety & marketing matters Scientific contact for M.Ds, Pharmacists and other health professionals Scientific contact for consumers & patients Liaise with corporate Medical & marketing dept. Transition into Actavis (2013) Transition and merging of Watson Pharmacovigilance System (PVSYS) to the Actavis 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 information SOP 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)
01/2013-04/2013	QS/QA Department Actavis – Specifar S.A. Athens, Greece
Brief Description Part of a team of 10 persons Quality complaints handling Product Technical Specifications preparation CAPA handling & Audit coordination
11/2010- 01/2013	Pharmacovigilance Associate – QS/QA dept. Specifar S.A. – Watson Pharmaceuticals Athens, Greece
Brief Description Pharmacovigilance Associate Part of a team of 3 persons and directly reporting to the Head of EU Scientific Affairs Transition 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 information Leading 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 Signals Co-operation with the Medical department regarding medicinal information and training Head of the audit team and CAPA implementation and follow up procedures Transition into Watson (2011) Co-ordinator for the transition to the Watson PSMF after merging of companies SOP 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 Assurance Coordination of Technical & Quality Agreements. Reporting to the QS/QA Manager
08/2008-10/2010	Pharmacovigilance QP Genepharm S.A. Athens Greece
Brief Description Acting as company’s QPPV. Part of a team of 12 persons and reporting to the Regulatory Affairs Vice President Creation of the company’s Pharmacovigilance System (PVSYS) from ground up along with relevant Standard Operation Procedures (SOPs).  This project involved co-ordination of various departments within the company and also direct co-ordination with the National Organization for Medicines. Also in strict contact with company’s partners regarding the exchange of safety information Start-up of a training project 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 Signals
03/2006-07/2008	Director Pharmacist Papafanis Pharmacy Athens Greece
Brief Description Direction of the pharmacy Leading a team of 4 persons Responsible for scientific compliance, orders and payments. Also acting as consultant to the local hospital physicians regarding scientific information, use and description of medicinal products
05/2005-02/2006	Military Service - Pharmacist Hellenic Army, 79th Medical Battalion Samos, Greece
Brief Description Responsible pharmacist for the battalion’s drug store. Part of a team of 7 persons, second to the Pharmacist leftenant’s command. Responsible for storage and distribution of medicinal supplies to the local brigade formation units Also acting as chief of ambulance paramedic team
01/2003-05/2005	Employee Pharmacist Farmacia Bartolotti Bologna Italy
Brief Description Working as pharmacist during day and night shift (when applicable for night shift). Part of team of 4 persons per shift Responsible for orders and payments as well for medicinal preparations performed in the pharmacy’s laboratory
01/1999-03/2005	Italian-Greek, Italian-English Interpreter Bologna International Exhibition Bologna Italy
Brief Description Freelance interpreter. Organization of exhibition business meetings and arrangements for accommodation and exhibition stand construction
IT Literacy
§  Windows, office pack, internet explorer, outlook Eudravigilance certified user (DIA, London U.K. EMEA, February 2009) Argus ArisG MedDRA
Languages
§  Greek: mother Language §  English: Proficiency level (TOEFL and Cambridge first certificate, TOEIC 2006) Italian: excellent, both spoken and written – Scientific level
Scientific Projects
09/2014	A Negative Association Between Lithium in Drinking Water and the Incidences of Homicides, in Greece Orestis Giotakos, George Tsouvelas,  Paul Nisianakis , Vera Giakalou, Alexandros Lavdas, Charalampos Tsiamitas, Katsaris Panagiotis, Vasilis Kontaxakis
10/2010	Pharmacovigilance as Drug Safety. (Hellenic American University/HAU; MBA Dissertation Thesis)
12/2007	What are the current communication needs in the Greek and European Market? (Hellenic American University, HAU)
12/2007	Cost of Cancer Drugs and Cancer Therapy. (HAU)
10/2007	Athens Hippokrateion General Hospital. (HAU)
04/2007	Pharmacovigilance and Crisis Management. (MBA dissertation thesis)
10/2004	Microorganisms, Bacteria and Toxins as Possible Bioterrorism Agents.(University Dissertation Thesis, Bologna Italy)
Congresses & Presentations
03/2016	1st Hellenic Pharmacoepidemiology Symposium – Alexandroupolis, Greece “Pharmacovigilance as a Scientific Basis for Drug Safety” Presentation along with the SFEE PhV-Team