Ігор

Name: IGOR SHKLIAREVYCH
Date of birth: December 30, 1980
Family: Married
Address: Kyiv, Ukraine
E-mail: [открыть контакты](см. выше в блоке «контактная информация»)
Phone: [открыть контакты](см. выше в блоке «контактная информация»)

Desired position: Pharmacovigilance Manager

Experience:

03/2022–04/2024 LLC SONA-PHARMEXIM (Importer, Distributor):
Position: Pharmacovigilance Manager, Contact Person Responsible for Pharmacovigilance (CPPV) in Ukraine, Functional manager of CPPV in Kazakhstan.
Responsibilities:
Maintenance and management of the Pharmacovigilance System with compliance with local and worldwide pharmacovigilance (PV) obligations.
Act as Responsible person for Pharmacovigilance Quality and Responsible for the proper functioning PV processes and PV Quality Management System (QMS) for Sona-Pharmexim Group (Ukraine & Kazakhstan).
QMS documents creation/update: GVP guide/ BCP/ SOPs/JDs/ Oversight Plans.
Development, update and implement local SOPs, Templates, Work instructions, CVs, JD and local Organizational Chart(s).
Act as local CPPV in Ukraine or deputy local CPPV in Kazakhstan.
Support review of local safety data exchange agreements (SDEAs) and compliance.
Maintenance a system of collection, assessment and submission of information on adverse reactions, lack of efficacy, other data relating to safety and efficacy in accordance with the legal requirements and GVP. 24/7 availability.
Intake, document, track and forwarding of Adverse Events (concerning Medicinal Products, Medical Devices, Nutritionals), special situations to HQ. Perform follow-up activities.
Submission of spontaneous ICSRs/Aggregate reports/Risk Management Plans to local HA.
Product quality complaints processing (with ICSR). Medical inquiries processing (with ICSR).
Implementation of aRMMs in the Territory of Responsibility.
Urgent safety communication (DHCP).
Support answering to requests from local HA.
Perform/organize local literature search (journals not listed in EMBASE). Maintain, check and update list, documentation of local literature search. Literature screening quality control.
Organize PV training for company employees.
Support of Patient support programs (PSP), Interactive digital media programs (IDM), Marketing research (MR) and and Other types of post-marketing studies (OTPMS) on PV issues (project coordination with marketing department, approval of PV Agreements with Third parties, staff training, ICSR processing, data reconciliation).
Business continuity management (OWH testing/BCP testing/ BCP implementation).
Record keeping (filing and archiving of all source documents and supporting documents).
Self-inspection and or PV audit preparation and conduction.
Manage or assist in management of PV audits from HQ. Prepare documentation for presentation during.

03/2018–02/2022 LLC CRATIA LTD (Consulting company):
Position: Pharmacovigilance Specialist, CPPV in Ukraine.
Responsibilities:
Maintenance and management of the Pharmacovigilance System with compliance with local and worldwide pharmacovigilance obligations.
Development, update and implement local SOPs, Templates, Work instructions, CVs, JD and local Organizational Chart(s).
Support review of local safety data exchange agreements (SDEAs) and compliance.
Maintenance a system of collection, assessment and submission of information on adverse reactions, lack of efficacy, AEFI, other data relating to safety and efficacy in accordance with the legal requirements and GVP. 24/7 availability.
Act as local PV contact person for Pharmacovigilance or deputy local PV contact person for local HA.
Intake, document, track and forwarding of Adverse Events (concerning medicinal products, nutritionals), special situations to HQ. Perform follow-up activities.
Submission of spontaneous ICSRs/Aggregate reports/Risk Management Plans to local HA.
Support answering to requests from local HA.
Perform/organize local literature search (journals not listed in EMBASE). Maintain, check and update list, documentation of local literature search.
Organize PV training for company employees.
Manage or assist in management of Pharmacovigilance audits from HQ. Prepare documentation for presentation during Pharmacovigilance audits.

04/2016–02/2018 LLC PHARMAGATE PLUS (Consulting company):
Position: Pharmacovigilance and Medical Information Specialist, CPPV in Ukraine.
Responsibilities:
Perform Individual Case Safety Report (ICSR).
Report spontaneous ICSRS to Health Authority.
Submit electronic reporting to Health Authority.
Submit PSURs to HA.
Review literature screening search.
Report Suspected Unexpected Serious Adverse Reactions to Health Authorities.
Signal detection. Submit PSURs and DDLs to HA.
Review literature screening search results, identifying ICSRs and other safety-related findings.
Monitoring of Regulatory Agencies recommendations.
Maintenance and management of the Pharmacovigilance System with compliance with local and worldwide pharmacovigilance obligations.

10/2013–08/2016 LLC PHARMAGATE PLUS (Consulting company):
Position: Regulatory Affairs Specialist
Responsibilities: Registration of Medicines, Biologics and Medical devices in Ukraine, cooperation with external environment (Regulatory Authorities).

08/2011–09/2013 Ukrainian Military Medical Academy:
Military service, rank — captain of medical service
Position: Senior Associate of the Head of Training Directorate
Responsibilities: Organization of training and scientific activity, coordination of meetings and conferences, cooperation with non-military research institutions.

07/2009 - 08/2011
Military service, rank — senior lieutenant of medical service
Research Institute of Military Medicine
Position: Research officer of the army medical department, pharmaceutical division
Responsibilities: Research activity (more than 10 published papers), cooperation with foreign medical research institutions, preparation of papers for international conferences, consultations.

Education:
2007– 2009
Ukrainian Military Medical Academy (Kyiv)
Specialty: Pharmacy
Qualification: Master of Pharmacy
(Top-1: Gold medal awarded for exceptional academic performance)

2001–2006
National Medical University named after O. O. Bogomolets (Kyiv)
Pharmaceutical Faculty,
Specialty: Pharmacy
Qualification: Pharmacist

Additional information:
Courses, Trainings, Seminar, Congresses:

2010 - Ukrainian Medical Military Academy: Administration in Pharmacy course

2013 - Pharmagate training center: Medical Product Regulatory Specialist course

2016 - Pharmagate training center: Pharmacovigilance system in Pharma organization

2016 - State Expert Center MoH Ukraine: Fourth scientific and practical conference “Safety and legal support of medicines: from development to medical use

2018 - State Expert Center MoH Ukraine: Structure and approaches to Risk Management Plan development and assessment

2019 - UA Right: Management and adverse drug reactions reporting in the pharmacovigilance system. Pharmacovigilance databases

2020 - UA Right: Criteria for evaluating the effectiveness of the applicant's pharmacovigilance system

2021 - LLC UKRMEDСERT: Applicant's Quality System. Approaches to its formation, creation of documents and evaluation criteria for pharmacovigilance processes

2022 - UA Right: Pharmacovigilance in the new Law "On Medicines" and what changes to expect in by-legal acts.

2023 - UA Right: Audit of the Applicant's pharmacovigilance system: analysis of recent practice and expert advice.

2024 - State Expert Center MoH Ukraine: PHARMA@PATIENT IN FOCUS 2024. PHARMACOVIGILANCE.

Languages: Russian and Ukrainian – native bilingual, English – intermediate (reading, writing).
Driving license: (В, С).
Software: WORD, EXEL, PowerPoint (Advanced).
Strengths: Dedicated, detail-oriented, ability to adapt to a fast-paced environment, excellent communication skills and ability to work within the team.

Date: 07.04.2024