Michalis Goulielmos
Clinical Pharmacist
Athens Metropolitan Area
Summary
- Training and practice in good laboratory practice which includes application and set up of basic analytical methods and synthetic reactions in an organic laboratory along with the adoption of a safe behaviour in a laboratory environment during elaboration of my undergraduate thesis project at Laboratory of Medicinal Chemistry of Department of Pharmacy, University of Patras.
- Familiarity with improvement of drug treatment (dosage assessment base on liver and/or kidney function, checking for possible drug interactions, spotting drug toxicity and adverse reactions and implementing efforts to minimize them) during my clinical practice in various private and public hospitals in Athens Metropolitan Area which constituted the whole 3rd semester of my postgraduate studies in Clinical Pharmacy and included visits with clinicians in inpatients.
- Training and familiarization with the general principles of Quality Assurance in the stages of delivery, storage and distribution of pharmaceuticals products also during my work experience in central pharmaceutical store of Hellenic Navy.
Overview
7
7
years of professional experience
7
7
years of post-secondary education
10
10
Certifications
Work History
Regulatory affairs officer & QPPV
Cooper Pharmaceuticals S.A.
Athens
10.2022 - Current
- Keep up to date with national and international legislation, guidelines and customer practices
- As the responsible officer for the Asia & Africa exports, ensure that the company's products comply with the regulations of the regions where they will be distributed
- Writing, preparing and amending the product's information texts (SmPC, PIL & Labelling) in accordance with EMA guidelines and regulations as well as providing high-quality medical translations of the concerned documents
- Monitoring, preparing and submitting applications for variations, renewals and marketing authorization approvals during national, MRP & DCP procedures as well as negotiating with the regulatory authorities in case of inquiries or deficiency letters
- Support and preparation of the below Common Technical Document (CTD) modules: Module 2.4, 2.5 4 and 5 compilation (e.g. Non-Clinical and Clinical Overviews).
- Preparing Biowaiver documentation and justification for the marketing authorization applications.
- Literature research/review for pharmacovigilance or other medical purposes and provision of scientific documentation for the support of the regulatory submissions
- Establishing and maintaining the MAH’s pharmacovigilance system
- Monitor the safety of the MAH’s drug products and coordinate actions to stay compliant with local legislation
- Serving as the 24/7 point of contact for Competent Authorities for safety issues
Scientific Affairs Officer
Pharminnova P.C.
Athens
01.2022 - 10.2024
- Support and preparation of the below Common Technical Document (CTD) modules: Module 2.4, 2.5 4 and 5 compilation (e.g. Non-Clinical and Clinical Overviews).
- Biowaiver documentation and justification
- Expert reports/scientific documentation
Pharmacist assistant
Hellenic Navy
Athens
11.2020 - 09.2021
- Work experience in central pharmaceutical store of Hellenic Navy (KEFN/DEA/TYY) at Botanikos Naval Fortress from 6/11/2020 to 23/9/2021 within military obligations fulfillment as Leading Sailor in Hellenic Navy.
- Complete training in producing galenic antiseptic solutions in full accordance with the Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and conditions determined by World Health Organization (WHO) during my work experience in central pharmaceutical store of Hellenic Navy (KΕΦΝ/ΔΕΑ/ΤΥΥ) as part of my military obligations fulfillment.
Pharmacist
Private Pharmacy
Pátrai
04.2018 - 07.2018
- Hired undergraduate practice in private pharmacy open to citizens from 1/4/2018 to 1/7/2018. The selection between the beneficiaries was made from the 50 undergraduate students with the highest average grade in undergraduate curriculum
- Utilised expert knowledge to clinically assess and treat patients in collaboration with multidisciplinary team.
- Communicated complex technical and medicine information within pharmacy and wider multidisciplinary team in easy to understand terms.
- Worked with other healthcare professionals to review quality of drugs.
- Established clear and effective customer service policies to increase satisfaction and pharmacy loyalty.
- Received prescriptions and checked against medical histories, safeguarding patient health and safety.
- Educated patients about correct medication dosage and storage.
Education
Master of Science - Pharmacy
University of Patras
Patras 09.2013 - 09.2018
Master of Science - Clinical Pharmacy
National and Kapodistrian University of Athens
Athens, Attica 10.2018 - 09.2020
Skills
Project Management
undefinedLanguages
Greek
Native
English
Proficient (C2)
Software
Diploma ECDL in computer science (core level) in 6 thematic units (Word, Excel, Outlook, Access, Windows 10, PowerPoint)
Training and established familiarity with Monolix© 2019R2, a software used for process and simulation of pharmacokinetic data, during elaboration of my thesis project in Postgraduate Program Study “Clinical Pharmacy
Interests
Watching movies and tv shows with particular interest at cinema
Reading literary books with special interest for novels, epic fantasy and seasonal books as well as books emphasizing in historical events
Participation in amateur football matches or in individual exercise when there is plenty free time available
Piano lessons with emphasis on classical music
Participation occasionally in various outdoor activities (such as trekking or rivertrekking)
Additional Information
Military obligations fulfilled as a leading Sailor (pharmacist and nurse assistant) in Hellenic Navy from 23/9/2020 to 23/9/2021.
Certification
Attendance of postgraduate seminar at Hygeia Private Hospital on March 2019 with theme: Rational antimicrobial chemotherapy for the clinician.
Timeline
HMA/EMA Oncology Educational Programme issued by EMA
07-2024
Pharmacovigilance (PV) Refresher & Update – 2023 issued by Excelya
11-2023
Certified MedDRA user: MedDRA Coding Basics and Advanced Med DRA coding.
07-2023
Signal Management in Pharmacovigilance 15-17th February, 2023.
02-2023
Notification-Successful completion of XEVMPD knowledge evaluation on 5th January 2023.
01-2023
Induction to Pharmacovigilance for clients. Training from Excelya held on 07 and 08 November 2022.
11-2022
Regulatory affairs officer & QPPV
Cooper Pharmaceuticals S.A.
10.2022 - Current
Scientific Affairs Officer
Pharminnova P.C.
01.2022 - 10.2024
Certificate for administration of vaccines and tetanus antitoxin to citizens granted from Hellenic Pharmacist Club with date of successful examination being 28/12/2020.
12-2020
Pharmacist assistant
Hellenic Navy
11.2020 - 09.2021
Successful attendance and examination of webinars provided by Advanced Pharma Education and Services of website: clinicalpharmacist.gr which targeted in optimal drug treatment of patients in several diseases: Schizophrenia, Clinical Depression, Bipolar Disorder, Diabetes Mellitus, Self-cure of Respiratory infections, Drug Interactions, Vaccines.
11-2020
Ssuance of profession exercise licence in all territory of Greece and EU from 26/8/2019.
08-2019
Attendance of postgraduate seminar at Hygeia Private Hospital on March 2019 with theme: Rational antimicrobial chemotherapy for the clinician.
03-2019
Master of Science - Clinical Pharmacy
National and Kapodistrian University of Athens
10.2018 - 09.2020
Pharmacist
Private Pharmacy
04.2018 - 07.2018
Master of Science - Pharmacy
University of Patras
09.2013 - 09.2018
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