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Специалист по фармаконадзору

Киев

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Curriculum vitae
Lyubov Nikitchenkova
24.06.1967
Kiev, Strokacha street 3,
Mobile number: 093-244-10-99
E-mail: 2013Chata@ukr.net

EDUCATION : 1984-1989 — Kharkov Pharmaceutical Institute. Speciality-pharmacist.
1991-2009 — every 5 years passing training courses at the National Medical Academy of Postgraduate Education im. P.L.Shupika.
2002 — Training at the Scientific and Expert Pharmacopeial center on “Validation of analytical methods analysis for drugs”.
2009 — Training “Regulatory Specialist registration of medicinal products, medical devices”.
2010 — Training “Specialist pharmacovigilance”.
2011-2012 — Training at the Academy of TUV, the internal auditor in accordance with the requirements of the ISO standard. Statistical methods.
2012 — Training “Quality control of medicines”.
2013 — Training “Preparation for the certification for compliance with GDP”.
2013-Training «Practical aspects of forming a registration dossier in the CTD format»
2014 — Training at the TUV Academy — an internal auditor in accordance with the requirements of ISO standard.
2015 — Workshop «Key aspects of the pharmacovigilance system of the applicant: standard operating procedures and databases»
2015-Conference seminar: «New order of examination of registration materials for medicinal products: a detailed analysis of the Order of the Ministry of Health of Ukraine №460»
2015 — Workshop «pharmacovigilance system master file»
2016-Basic course of oratory
PROFESSIONAL EXPERIENCE: 2016- March-at the present time
Company «ProPharma»
specialist of pharmacovigilance and clinical trails
Responsibilities:
— Planning, organization, coordination, control implementation, maintenance and continuous improvement of the proper functioning of the pharmacovigilance system,
— Monitoring of laws and legal documents regulating the implementation of pharmacovigilance activities, including international law and bring to the attention of his subordinates,
— Collection, documentation, analysis, archiving reports identified side effects / lack of efficacy and other problems associated with the use of the safety of drugs approved for treatment,
— Monitoring drug safety profile, including the assessment of the benefit / risk
— Development of the pharmacovigilance system master file, risk management plan (RMP), addendum to the clinical overview (ACO)
— Provision PSURs according to schedule, a detailed description of the pharmacovigilance system, additional information at the request of the competent authorities,
— Monitoring of local medical literature, the Internet source and other sources for information about adverse reactions,
— Development of standard operating procedures (SOPs) and participation in the development of document management company with pharmacovigilance, participation in conducting internal audits of the Company»s system of pharmacovigilance,
— Carrying out regular training of pharmacological safety for all employees, including training for medical representatives, distributors,
— Participation in external audits and implementation CAPA

2009-2016
Private enterprise “Maxima Health Research”
Deputy of Qualified Person for Pharmacovigilance
Head of Quality Control Department
Responsibilities:
• Cooperation with the head office of the Company and the Company»s structural units as part of their official duties
• Monitoring of laws and legal documents regulating the implementation of pharmacovigilance activities, including international law and the legal framework regions of the CIS countries and Ukraine and bringing to the attention of his subordinates
• Collection, documentation, analysis, archiving reports identified side effects / lack of efficacy and other problems associated with the use of the safety of drugs approved for treatment in Ukraine and CIS countries where is registered drugs
• Monitoring drug safety profile, including the assessment of the benefit / risk
• Development of the pharmacovigilance system master file, risk management plan (RMP), addendum to the clinical overview (ACO)
• Provision PSURs according to schedule to HA in Ukraine and CIS countries, additional information at the request of the competent authorities,
• Development and support of the pharmacovigilance system in the CIS countries
• Monitoring of local medical literature, the Internet source and other sources for information about adverse reactions
• Development of standard operating procedures (SOPs) and participation in the development of document management company with pharmacovigilance, participation in conducting internal audits of the Company»s system of pharmacovigilance
• Carrying out regular training of pharmacological safety for all employees, including training for medical representatives, distributors,
• Participation in external audits and implementation CAPA
• The organization of the development and implementation of measures of the quality management systems of the Company in accordance with the requirements of international quality standard ISO 9001 and to ensure their compliance with the internal market needs and export requirements
• Monitoring processes of the company to develop a strategy of corrective and preventive actions;
• Carrying out Internal audits (ISO 19011)
1998 – 2009
State Administration of Ukraine on Medicinal Products (SAUMP)
Chief specialist of the department of inspection and quality control
laboratory drugs
Verification of compliance with business entities and medical institutions of legal requirements regarding the quality of drugs during their manufacture, storage, transport, sale and medical use. Conducting analysis of medicines. I own all kinds of laboratory monitoring, legislative, registration, regulatory and technical literature.
1989-1998
Pharmacist Analyst control of analytical laboratory. Pharmacy Association «Pharmacy» in Kiev
Conducting analyzes of drugs, substances. Own with all kinds of laboratory control, legal, registration, regulatory and technical literature. I participated in the development of techniques for the analysis of drugs, extemporaneous composition.
Languages knowledge: Russian, Ukrainian — mother languages, English — Intermediate
Additional information: Driving license category B, driving experience 12 years.
Computer skills: advanced user (MS Office, Word, Excel, Internet, E-mail, 1C), office equipment. The absence of bad habits, energy, initiative, independence, responsibility, communication skills, fast learner.

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