Besa Gjika (Begolli)
Tirana
Summary
Experienced pharmacist with a background in pharmaceutical law and regulations and 10 years of a diversified experience in Pharmaceutical Distribution, Quality Assurance Management, Regulatory Affairs and Pharmacovigilance. An experienced Regulatory Affairs professional with a comprehensive understanding of legal regulations and compliance requirements. Proven ability to manage complex legal issues, create policies and procedures, and ensure compliance with legal regulations. Motivated for new challenging assignments and ready to improve my career in Pharmaceutical Sciences World.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Regulatory Affairs, QA and PV Specialist
MEDICAMENTA SHPK
12.2024 - Current
- Developed and enforced policies and procedures to ensure compliance with legal and regulatory standards
- prepared submissions of new registration, variations and renewals of Marketing Authorization dossiers to strict deadlines
- Successfully submitted applications for new registration, renewal of Marketing Authorization and variations for Medical Devices
- ensure that a company's products comply with the regulations of the regions where they want to distribute them
- kept up to date with national and international legislation, guidelines and customer practices
- involved in the price declaration procedure complying with legal and regulatory requirements
- wrote clear, accessible product labels and patient information leaflets
- made literature monitoring in weekly bases
- submitted line listings and PSURs to Health Authority.
- Maintained and improved the exiting quality processes to ensure continuously appropriate/compliant operation of quality processes
- Worked closely with other departments to facilitate actions and maintained compliance to the current systems for change controls, CAPA, deviation, complaints, internal GDP audit observation follow up
- Carried out investigation of GDP non-compliance and/or customer product quality complaints
- Provided quality tools and techniques to perform and documented full root cause investigation, to evaluate and resolve quality issues, and to enhance continuous improvement
- Aided with development of corrective and preventive actions plans and implement these within a given guideline to eliminate the root cause of a non-conformance
- Updated, maintained and improved quality management system process documents and documentation
- Performed data analyses, prepared quality trend/metrics, and report results to internal interested pares
- Prepared SOPs and maintain documentation according to applicable regulations .
- Reviewed periodically to ensure that all standard operating procedures reflect the most up-to-date, internationally accepted practices in accordance with GDP and ensured compliance with evolving innovation or changes to processes or products.
- Organized and managed training matrix for all warehouse personnel.
- Ensured that training is conducted for all new SOPs with periodic refresher training.
- Wrote daily reports for accountability and quality assurance
Regulatory affairs and Pharmacovigilance Specialist
Trimed healthcare
03.2024 - 12.2024
- Developed and enforced policies and procedures to ensure compliance with legal and regulatory standards
- Prepared submissions of licence, variations and renewals dossiers to strict deadlines
- Successfully submitted applications for new registration, renewal of Marketing Authorization and variations for Medical Devices.
- Ensure that a company's products comply with the regulations of the regions where they want to distribute them
- Kept up to date with national and international legislation, guidelines and customer practices
- Involved in the price declaration procedure complying with legal and regulatory requirements
- Wrote clear, accessible product labels and patient information leaflets
- Made literature monitoring in weekly bases
- Submitted line listings and PSURs to Health Authority
Head of Quality Assurance and Pharmacovigilance
AVICENA
06.2022 - 03.2024
- Maintained and improved the exiting quality processes to ensure continuously appropriate/compliant operation of quality processes
- Worked closely with other departments to facilitate actions and maintained compliance to the current systems for change controls, CAPA, deviation, complaints, internal GDP audit observation follow up
- Carried out investigation of GDP non-compliance and/or customer product quality complaints
- Provided quality tools and techniques to perform and documented full root cause investigation, to evaluate and resolve quality issues, and to enhance continuous improvement
- Aided with development of corrective and preventive actions plans and implement these within a given guideline to eliminate the root cause of a non-conformance
- Updated, maintained and improved quality management system process documents and documentation
- Performed data analyses, prepared quality trend/metrics, and report results to internal interested pares
- Prepared SOPs and maintain documentation according to applicable regulations.
- Reviewed periodically to ensure that all standard operating procedures reflect the most up-to-date, internationally accepted practices in accordance with GDP and ensured compliance with evolving innovation or changes to processes or products.
- Organized and managed training matrix for all warehouse personnel.
- Ensured that training is conducted for all new SOPs with periodic refresher training.
- Wrote daily reports for accountability and quality assurance.
DIRECTOR OF PHARMACY
DITE E NATE PHARMACY
01.2021 - 08.2022
- Built and maintained good relationship with costumers and staff Monitored the sales
- Successfully reached better sales target
- Managed pharmacy operations
- Organized the inventory Provided good quality of medicines
- Continuously updating professional knowledge
- Maintained pharmacy inventory by checking pharmaceutical stock to determine inventory level; anticipating needed medications and supplies; placing and expediting orders; verifying receipt; removing outdated drugs.
- Maintained a safe and clean pharmacy by complying with procedures, rules, and regulations.
- Organized medications for pharmacist to dispense by reading medication orders and prescriptions; preparing labels; calculating quantities; assembling intravenous solutions and other pharmaceutical therapies.
- Maintained records by recording and filing physicians' orders and prescriptions.
- Generated revenues by calculating, recording, and issuing charges.
- Ensured medication availability by delivering medications to patients and departments.
DIRECTOR OF FARMACY
NERSI PHARMA
11.2019 - 01.2021
- Maintaineed pharmacy inventory by checking pharmaceutical stock to determine inventory level; anticipating needed medications and supplies; placing and expediting orders; verifying receipt; removing outdated drugs.
- Maintained a safe and clean pharmacy by complying with procedures, rules, and regulations.
- Organized medications for pharmacist to dispense by reading medication orders and prescriptions; preparing labels; calculating quantities; assembling intravenous solutions and other pharmaceutical therapies.
- Maintained records by recording and filing physicians' orders and prescriptions.
- Generated revenues by calculating, recording, and issuing charges. Ensures medication availability by delivering medications to patients and departments
- Identified and maximized sales opportunities, and increased customer retention rates.
DIRECTOR AND OWNER OF PHARMACY
ORI PHARMA
10.2017 - 11.2019
- Built and maintained good relationship with costumers and staff
- Monitored the sales Successfully reached better sales target Managed pharmacy operations
- Organized the inventory Provided good quality of medicines
- Continuously updating professional knowledge
PHARMACIST
ORI PHARMA
02.2015 - 10.2017
- Built and maintained good relationship with costumers and staff
- Monitored the sales
- Organized the inventor Continuously updating professional knowledge
Education
SCIENCE ORIENTED HIGHT SCHOOL -
NEHEMIA SCHOOL
07.2010
MASTER DEGREE - PHARMACEUTICAL SCIENCES
UNIVERSITY OF MEDICINE
TIRANA, TIRANE08.2015
Skills
- Proficient in Microsoft 365
- Critical thinking and problem solving
- Communication Skills
- Collaborative teamwork skills
- Microsoft Office
- Adaptability
- Fast Learner
- Leadership Skills
- Effective Time Management
- Hard worker
Websites
Languages
Italian
German
Spanish
English
Certification
- Pharmacovigilance Risk Management Plan
- REGULATORY ASPECTS OF PHARMACOVIGILANCE
- REGULATORY AFFAIRS AND CLINICAL WRITING
- CLINICAL DATA MANAGEMENT
- PV MANAGEMENT SYSTEM AND TERMINOLOGIES
- COLLECTING HIGH QUALITY ADR REPORTS
- DRUG LIFE CYCLE AS A TOOL IN DRUG POLICY ANALYSIS
- SIGNAL DETECTION AND CAUSALITY ASSESSMENT
- STATISTICAL REASONING AND ALGORITHMS IN PHARMACOVIGILANCE
- QUALITY AND REGULATORY: EU PRODUCTS LEGISLATION AND CE MARKING
- DRIVING LICENCE LEVEL B
Timeline
Regulatory Affairs, QA and PV Specialist
MEDICAMENTA SHPK
12.2024 - Current
Regulatory affairs and Pharmacovigilance Specialist
Trimed healthcare
03.2024 - 12.2024
Head of Quality Assurance and Pharmacovigilance
AVICENA
06.2022 - 03.2024
DIRECTOR OF PHARMACY
DITE E NATE PHARMACY
01.2021 - 08.2022
DIRECTOR OF FARMACY
NERSI PHARMA
11.2019 - 01.2021
DIRECTOR AND OWNER OF PHARMACY
ORI PHARMA
10.2017 - 11.2019
PHARMACIST
ORI PHARMA
02.2015 - 10.2017
MASTER DEGREE - PHARMACEUTICAL SCIENCES
UNIVERSITY OF MEDICINE
SCIENCE ORIENTED HIGHT SCHOOL -
NEHEMIA SCHOOL
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