PHARMACOVIGILANCE, REGULATORY AND QUALITY AFFEIRS.
Aktualisiert am 14.08.2024
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Verfügbar ab: 14.08.2024
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Regulatory Affairs
Good Pharmacovigilance Practice
Good Manufacturing Practice
Qualitymanagement
Good Clinical Data Management Practice
UKRAINIAN
Mother tongue
RUSSIAN
Mother tongue
ENGLISH
Proficient user
GERMAN
Basic user

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

5 years 2 months
2019-11 - now

Management procedures of registration

OUTSOURCING PHARMACOVIGILANCE, REGULATORY AND QUALITY MANAGER
OUTSOURCING PHARMACOVIGILANCE, REGULATORY AND QUALITY MANAGER
  • Management procedures of registration, registration, changes/variations of products in Ukraine and CIS countries.
  • Management of GMP approval and updates.
  • Management of PV and Regulatory databeses (Argus, LSMV, 1C), develpment of MAH individual/custom database.
  • PV and Regulatory procedures in veterinary pharmaceutical industry
  • Regulatory functions for food supplements, cosmetics and medical devices (CIS countries)
  • Regulatory intelligence monitoring
  • Pharmacovigilance intelligence monitoring (PRAC and other safety recomendations)
  • Pharmacovigilance activities in Ukraine.
  • Development and support pharmacovigilance system.
  • Development and support master file.
  • Development and support SOP base.
  • Safety signals management.
  • Archiving documentation.
  • Communicating with regulatory authorities.
  • Communication with regulators and opinion leaders.
  • Processing of local documentation.
  • Development, update and approval of SmPC and instruction for medical use.
  • Development, update and approval of PSUR, RMP, ACO.
  • Development update and approval of periodic benefit-risk evaluation report (PBRER).
  • Quality assurance (laboratory control, batch release, CoA, import of laboratory / pharmacopoeia (reference) samples).
  • Approval of the artworks and packages.
  • Training of staff.
  • Audit (internal and external).
on request
Kyiv, Ukraine
1 year 7 months
2022-09 - 2024-03

Pharmacovigilance activities

PHARMACOVIGILANCE MANAGER (CPPV)
PHARMACOVIGILANCE MANAGER (CPPV)
  • Pharmacovigilance activities in Ukraine.
  • Database maintenance (LSMV, Veeva)
  • Compliance control
  • Local literature review
  • Regulatory intelligence monitoring
  • Pharmacovigilance intelligence monitoring (PRAC and other safety recomendations)
  • Development and support pharmacovigilance system.
  • Development and support master file.
  • Support SOP base.
  • Safety signals management (ICSR, SUSAR).
  • Communicating with regulatory authorities.
  • Processing of local documentation.
  • Adaptation and approval of PSUR, RMP, ACO.
  • Adaptation and approval of periodic benefit-risk evaluation report (PBRER).
  • Adaptation, submission and approval of DSUR, PASS.
  • Training of staff.
  • Audit.
BOEHRINGER INGELHEIM
Kyiv, Ukraine
2 years 2 months
2020-07 - 2022-08

PV database maintenance

PHARMACOVIGILANCE MANAGER (LSO)
PHARMACOVIGILANCE MANAGER (LSO)
  • Pharmacovigilance activities in Ukraine.
  • PV database maintenance (Argus, 1C(based)).
  • Compliance control.
  • Local literature review.
  • Regulatory intelligence monitoring.
  • Development and support of pharmacovigilance system.
  • Development and support of master file.
  • Support SOP base.
  • Safety signals management.
  • Communicating with regulatory authorities.
  • Processing of local documentation.
  • Adaptation of PSUR, RMP, ACO.
  • Adaptation of periodic benefit-risk evaluation report (PBRER).
  • Training of staff.
  • Audit (internal and external).
BIOMAPAS
Kyiv, Ukraine
1 year 1 month
2018-11 - 2019-11

Management procedures of registration

PHARMACOVIGILANCE, REGULATORY AND QUALITY MANAGER
PHARMACOVIGILANCE, REGULATORY AND QUALITY MANAGER
  • Management procedures of registration, registration, changes/variations of products in Ukraine and CIS countries.
  • Quality assurance (laboratory control, batch release, CoA, import of laboratory / pharmacopoeia (reference) samples).
  • Management of GMP approval and updates.
  • Approval of the artworks and packages.
  • Responsibility for pharmacovigilance system functioning and compliance.
  • Support and development of MAH pharmacovigilance system in Ukraine.
  • Support master file.
  • Support SOP base.
  • Regulatory intelligence monitoring
  • Pharmacovigilance intelligence monitoring (PRAC and other safety recomendations)
  • Archiving documentation.
  • Safety signals management.
  • Communicating with regulatory authorities.
  • Communication with regulators and opinion leaders.
  • Processing of local documentation.
  • Managing of SmPC and instruction for medical use.
  • Adaptation, update and approval of PSUR, RMP, ACO.
  • Adaptation, update and approval of periodic benefit-risk evaluation report (PBRER).
  • Training of staff.
?ALKALOID KIEV? CO. LTD.
Kyiv, Ukraine
2 years
2016-12 - 2018-11

Responsibilities for pharmacovigilance system functioning

PHARMACOVIGILANCE SPECIALIST
PHARMACOVIGILANCE SPECIALIST
  • Responsibilities for pharmacovigilance system functioning.
  • Regulatory intelligence monitoring
  • Pharmacovigilance intelligence monitoring (PRAC and other safety recomendations)
  • Support and development of MAH pharmacovigilance system.
  • Support and development of master file.
  • Support and development of SOP base.
  • Archiving documentation.
  • Safety signals management.
  • Communication with regulatory authorities.
  • Communication with regulators and opinion leaders.
  • Processing of local documentation.
  • Managing of SmPC and instruction for medical use.
  • Development, update and approval of PSUR, RMP, ACO.
  • Development, update and approval of periodic benefit-risk evaluation report (PBRER).
  • Managing procedures of update, changes/variations of dossier documentation.
  • Support procedures of reregistration.
  • Proofreading of the artworks and packages.
  • Training of staff.
PRJSC ?PHARMACEUTICAL FIRM ?DARNITSA?
1 year 11 months
2015-01 - 2016-11

Responsibilities for pharmacovigilance system

QUALIFIED PERSON RESPONSIBLE FOR PHARMACOVIGILANCE (QPPV)
QUALIFIED PERSON RESPONSIBLE FOR PHARMACOVIGILANCE (QPPV)
  • Responsibilities for pharmacovigilance system functioning and compliance.
  • Creating, support and development of MAH pharmacovigilance system pharmacovigilance system.
  • Creating, support and development of master file.
  • Creating, support and development of SOP base.
  • Archiving documentation.
  • Safety signals management.
  • Communication with regulatory authorities.
  • Preparation of the dossier (procedures of the variations and updates).
  • Communication with regulators and opinion leaders.
  • Processing of local documentation.
  • Managing of SmPC and instruction for medical use.
  • Development, update and approval of PSUR, RMP, ACO.
  • Development, update and approval of periodic benefit-risk evaluation report (PBRER).
  • Approval of the artworks and packages.
  • Regulatory intelligence monitoring.
  • Pharmacovigilance intelligence monitoring (PRAC and other safety recomendations).
  • Training of staff.
LLC ?EURO PHARMA INTERNATIONAL?
Kyiv, Ukraine
1 year
2014-01 - 2014-12

Archiving dossier materials.

REGULATORY ASSISTANT
REGULATORY ASSISTANT
  • Archiving dossier materials.
  • Expertise of dossier content.
  • Dossier adaptation and preparation for submission.
  • Cooperation with regulators.
  • Numerous assistant tasks and functions.
  • Proofreading of documantation.
BERLIN-CHEMIE AG
Kyiv, Ukraine
1 year
2013-01 - 2013-12

Archiving dossier materials

REGULATORY ASSISTANT
REGULATORY ASSISTANT
  • Archiving dossier materials.
  • Expertise of dossier content.
  • Dossier adaptation and preparation for submission.
  • Cooperation with regulators.
  • Numerous assistant tasks and functions.
  • Proofreading of documantation.
MSD (MERCK (MERCK SHARP & DOHME))
Kyiv, Ukraine

Aus- und Weiterbildung

Aus- und Weiterbildung

2014 ? 2015:

PHARMACOLOGIST (PHARMACY)

Kharkiv Medical Academy of Post-graduate Education, Kyiv, Ukraine


2009 ? 2014:

PHARMACOLOGIST (CLINICAL & INDUSTRIAL)

BOGOMOLETS NATIONAL MEDICAL UNIVERSITY, Kyiv, Ukraine


«STRUCTURE AND APPROACHES TO PERIODIC SAFETY UPDATE REPORT DEVELOPMENT AND ASSESSMENT»

UrkMedCert, Kyiv, Ukraine


«BENEFIT-RISK ASSESSMENT APPROACHES AND METHODS», «RISK, BENEFIT AND RATIO BENEFIT/RISK ASSESSMENT FOR USING MEDICINES», «MODERN REQUIREMENTS FOR RISK MANAGEMENT IN THE PV SYSTEM»

State Expert Center MoH Ukraine, Kyiv, Ukraine


«GVP. TRAINING COURSE FOR THE QUALIFIED PERSON RESPONSIBLE FOR PV/CONTACT PERSON RESPONSIBLE FOR PV» "Standards Technology Development"

STD Ltd, Kyiv, Ukraine


«QUALITY SYSTEM OF THE APPLICANT'S PV SYSTEM: STRUCTURE, FEATURES OF CONSTRUCTION AND MONITORING» "Standards Technology Development"

STD Ltd, Kyiv, Ukraine

Kompetenzen

Kompetenzen

Top-Skills

Regulatory Affairs Good Pharmacovigilance Practice Good Manufacturing Practice Qualitymanagement Good Clinical Data Management Practice

Produkte / Standards / Erfahrungen / Methoden

DIGITAL SKILLS

  • Microsoft Office 
  • Microsoft Word 
  • Sharepoint 
  • Microsoft Powerpoint 
  • LSMV 
  • ARGUS 
  • 1C
  • Remote 
  • Third Parties Management 
  • Compliance Control 
  • Crisis management

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

5 years 2 months
2019-11 - now

Management procedures of registration

OUTSOURCING PHARMACOVIGILANCE, REGULATORY AND QUALITY MANAGER
OUTSOURCING PHARMACOVIGILANCE, REGULATORY AND QUALITY MANAGER
  • Management procedures of registration, registration, changes/variations of products in Ukraine and CIS countries.
  • Management of GMP approval and updates.
  • Management of PV and Regulatory databeses (Argus, LSMV, 1C), develpment of MAH individual/custom database.
  • PV and Regulatory procedures in veterinary pharmaceutical industry
  • Regulatory functions for food supplements, cosmetics and medical devices (CIS countries)
  • Regulatory intelligence monitoring
  • Pharmacovigilance intelligence monitoring (PRAC and other safety recomendations)
  • Pharmacovigilance activities in Ukraine.
  • Development and support pharmacovigilance system.
  • Development and support master file.
  • Development and support SOP base.
  • Safety signals management.
  • Archiving documentation.
  • Communicating with regulatory authorities.
  • Communication with regulators and opinion leaders.
  • Processing of local documentation.
  • Development, update and approval of SmPC and instruction for medical use.
  • Development, update and approval of PSUR, RMP, ACO.
  • Development update and approval of periodic benefit-risk evaluation report (PBRER).
  • Quality assurance (laboratory control, batch release, CoA, import of laboratory / pharmacopoeia (reference) samples).
  • Approval of the artworks and packages.
  • Training of staff.
  • Audit (internal and external).
on request
Kyiv, Ukraine
1 year 7 months
2022-09 - 2024-03

Pharmacovigilance activities

PHARMACOVIGILANCE MANAGER (CPPV)
PHARMACOVIGILANCE MANAGER (CPPV)
  • Pharmacovigilance activities in Ukraine.
  • Database maintenance (LSMV, Veeva)
  • Compliance control
  • Local literature review
  • Regulatory intelligence monitoring
  • Pharmacovigilance intelligence monitoring (PRAC and other safety recomendations)
  • Development and support pharmacovigilance system.
  • Development and support master file.
  • Support SOP base.
  • Safety signals management (ICSR, SUSAR).
  • Communicating with regulatory authorities.
  • Processing of local documentation.
  • Adaptation and approval of PSUR, RMP, ACO.
  • Adaptation and approval of periodic benefit-risk evaluation report (PBRER).
  • Adaptation, submission and approval of DSUR, PASS.
  • Training of staff.
  • Audit.
BOEHRINGER INGELHEIM
Kyiv, Ukraine
2 years 2 months
2020-07 - 2022-08

PV database maintenance

PHARMACOVIGILANCE MANAGER (LSO)
PHARMACOVIGILANCE MANAGER (LSO)
  • Pharmacovigilance activities in Ukraine.
  • PV database maintenance (Argus, 1C(based)).
  • Compliance control.
  • Local literature review.
  • Regulatory intelligence monitoring.
  • Development and support of pharmacovigilance system.
  • Development and support of master file.
  • Support SOP base.
  • Safety signals management.
  • Communicating with regulatory authorities.
  • Processing of local documentation.
  • Adaptation of PSUR, RMP, ACO.
  • Adaptation of periodic benefit-risk evaluation report (PBRER).
  • Training of staff.
  • Audit (internal and external).
BIOMAPAS
Kyiv, Ukraine
1 year 1 month
2018-11 - 2019-11

Management procedures of registration

PHARMACOVIGILANCE, REGULATORY AND QUALITY MANAGER
PHARMACOVIGILANCE, REGULATORY AND QUALITY MANAGER
  • Management procedures of registration, registration, changes/variations of products in Ukraine and CIS countries.
  • Quality assurance (laboratory control, batch release, CoA, import of laboratory / pharmacopoeia (reference) samples).
  • Management of GMP approval and updates.
  • Approval of the artworks and packages.
  • Responsibility for pharmacovigilance system functioning and compliance.
  • Support and development of MAH pharmacovigilance system in Ukraine.
  • Support master file.
  • Support SOP base.
  • Regulatory intelligence monitoring
  • Pharmacovigilance intelligence monitoring (PRAC and other safety recomendations)
  • Archiving documentation.
  • Safety signals management.
  • Communicating with regulatory authorities.
  • Communication with regulators and opinion leaders.
  • Processing of local documentation.
  • Managing of SmPC and instruction for medical use.
  • Adaptation, update and approval of PSUR, RMP, ACO.
  • Adaptation, update and approval of periodic benefit-risk evaluation report (PBRER).
  • Training of staff.
?ALKALOID KIEV? CO. LTD.
Kyiv, Ukraine
2 years
2016-12 - 2018-11

Responsibilities for pharmacovigilance system functioning

PHARMACOVIGILANCE SPECIALIST
PHARMACOVIGILANCE SPECIALIST
  • Responsibilities for pharmacovigilance system functioning.
  • Regulatory intelligence monitoring
  • Pharmacovigilance intelligence monitoring (PRAC and other safety recomendations)
  • Support and development of MAH pharmacovigilance system.
  • Support and development of master file.
  • Support and development of SOP base.
  • Archiving documentation.
  • Safety signals management.
  • Communication with regulatory authorities.
  • Communication with regulators and opinion leaders.
  • Processing of local documentation.
  • Managing of SmPC and instruction for medical use.
  • Development, update and approval of PSUR, RMP, ACO.
  • Development, update and approval of periodic benefit-risk evaluation report (PBRER).
  • Managing procedures of update, changes/variations of dossier documentation.
  • Support procedures of reregistration.
  • Proofreading of the artworks and packages.
  • Training of staff.
PRJSC ?PHARMACEUTICAL FIRM ?DARNITSA?
1 year 11 months
2015-01 - 2016-11

Responsibilities for pharmacovigilance system

QUALIFIED PERSON RESPONSIBLE FOR PHARMACOVIGILANCE (QPPV)
QUALIFIED PERSON RESPONSIBLE FOR PHARMACOVIGILANCE (QPPV)
  • Responsibilities for pharmacovigilance system functioning and compliance.
  • Creating, support and development of MAH pharmacovigilance system pharmacovigilance system.
  • Creating, support and development of master file.
  • Creating, support and development of SOP base.
  • Archiving documentation.
  • Safety signals management.
  • Communication with regulatory authorities.
  • Preparation of the dossier (procedures of the variations and updates).
  • Communication with regulators and opinion leaders.
  • Processing of local documentation.
  • Managing of SmPC and instruction for medical use.
  • Development, update and approval of PSUR, RMP, ACO.
  • Development, update and approval of periodic benefit-risk evaluation report (PBRER).
  • Approval of the artworks and packages.
  • Regulatory intelligence monitoring.
  • Pharmacovigilance intelligence monitoring (PRAC and other safety recomendations).
  • Training of staff.
LLC ?EURO PHARMA INTERNATIONAL?
Kyiv, Ukraine
1 year
2014-01 - 2014-12

Archiving dossier materials.

REGULATORY ASSISTANT
REGULATORY ASSISTANT
  • Archiving dossier materials.
  • Expertise of dossier content.
  • Dossier adaptation and preparation for submission.
  • Cooperation with regulators.
  • Numerous assistant tasks and functions.
  • Proofreading of documantation.
BERLIN-CHEMIE AG
Kyiv, Ukraine
1 year
2013-01 - 2013-12

Archiving dossier materials

REGULATORY ASSISTANT
REGULATORY ASSISTANT
  • Archiving dossier materials.
  • Expertise of dossier content.
  • Dossier adaptation and preparation for submission.
  • Cooperation with regulators.
  • Numerous assistant tasks and functions.
  • Proofreading of documantation.
MSD (MERCK (MERCK SHARP & DOHME))
Kyiv, Ukraine

Aus- und Weiterbildung

Aus- und Weiterbildung

2014 ? 2015:

PHARMACOLOGIST (PHARMACY)

Kharkiv Medical Academy of Post-graduate Education, Kyiv, Ukraine


2009 ? 2014:

PHARMACOLOGIST (CLINICAL & INDUSTRIAL)

BOGOMOLETS NATIONAL MEDICAL UNIVERSITY, Kyiv, Ukraine


«STRUCTURE AND APPROACHES TO PERIODIC SAFETY UPDATE REPORT DEVELOPMENT AND ASSESSMENT»

UrkMedCert, Kyiv, Ukraine


«BENEFIT-RISK ASSESSMENT APPROACHES AND METHODS», «RISK, BENEFIT AND RATIO BENEFIT/RISK ASSESSMENT FOR USING MEDICINES», «MODERN REQUIREMENTS FOR RISK MANAGEMENT IN THE PV SYSTEM»

State Expert Center MoH Ukraine, Kyiv, Ukraine


«GVP. TRAINING COURSE FOR THE QUALIFIED PERSON RESPONSIBLE FOR PV/CONTACT PERSON RESPONSIBLE FOR PV» "Standards Technology Development"

STD Ltd, Kyiv, Ukraine


«QUALITY SYSTEM OF THE APPLICANT'S PV SYSTEM: STRUCTURE, FEATURES OF CONSTRUCTION AND MONITORING» "Standards Technology Development"

STD Ltd, Kyiv, Ukraine

Kompetenzen

Kompetenzen

Top-Skills

Regulatory Affairs Good Pharmacovigilance Practice Good Manufacturing Practice Qualitymanagement Good Clinical Data Management Practice

Produkte / Standards / Erfahrungen / Methoden

DIGITAL SKILLS

  • Microsoft Office 
  • Microsoft Word 
  • Sharepoint 
  • Microsoft Powerpoint 
  • LSMV 
  • ARGUS 
  • 1C
  • Remote 
  • Third Parties Management 
  • Compliance Control 
  • Crisis management

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