Ольга

Olga Moshnina
Medical manager, Disease area expert
neuroscience, Pharmacovigilance manager,
Local QPPV, Medical editor, Clinical resident,
Doctor

Work Experience

Medical manager, Disease area expert
Contact me neuroscience. Medical Affairs

DOB 22-Oct-1976 Roche
4 Reheneratorna St., Jul 2022 - Present

Apt 1-345, Kyiv, Ukraine
Provide medical expertise to the marketing team, assisting in
[открыть контакты](см. выше в блоке «контактная информация») the creation of scientifically accurate materials that comply
[открыть контакты](см. выше в блоке «контактная информация») with regulatory standards/
Support or lead key tactics by providing scientific expertise
[открыть контакты](см. выше в блоке «контактная информация») (advisory boards, medical education, speaker briefings,
2149561a2 preparation of reimbursement dossiers etc.) by close
collaboration with other functions, and engaging with external
Profile stakeholders when required.
I am a qualified and confident medical Build mutually respected partnerships with scientific society
manager, physician, medical editor, and with individual TAE’s, drive broad collaboration across all
pharmacovigilance manager, and clinical stakeholders.
resident with extensive experience in clinical Key strategic scientific partner to engage with external
settings and pharmaceutical companies. I have stakeholders to enable successful clinical trials execution.
a strong academic clinical background and an Supports the teams to define and communicate medical value.
understanding of the pharmaceutical industry. Medical Education, co-create high value-added continuing
Competent in researching facts and familiar medical educational programs for external stakeholders
with medical terminology and the latest Supports the conduct of Roche clinical trials and other data
happenings in the medical world. I have generation activities, including participation in site feasibility
experience in successful development and activities, pre-activation site visits, and others.
implementation of new projects. Uncovers local evidence gaps & helps to strategically address
them.
Skills Advanced therapeutic area knowledge and clinical
Good understanding of the healthcare system development guidelines and directives.
environment, including health care policy, the Evaluate and propose the Local Compassionate Use/ Pre-
reimbursement environment and health approval Access programs in the disease area. Manage the
technology assessment environment. evaluation of patient eligibility and all the procedures to
Robust understanding of pharmaceutical drug activate the eventual treatment approval, importation and
development, medical affairs strategies and supply. Set-up the program with consultation of HCPs for local
tactics including clinical research and main programs.
industry medical compliance processes. Implementing digital solutions for customers (website, app,
Ability to be a strong partner with multiple newsletters etc.)
stakeholders. Understand the health ecosystem (Payers, Health Authorities,
Strong data comprehension, critical appraisal, PAGs).
synthesis interpretation and delivery of Provides medical review (and certification if qualified) for
data/information skills. external materials and communications.
Evidence generation and GxP knowledge. Review and approval process of grants and donations.
Scientific and Publication management. Deliver relevant content/ensure content accuracy of core
Strategic planning skills. documents, e.g., SmPC, etc
Strong communications and presentation As per local medical information regulations and Roche
skills. policies and SOPs, ensures proper responses to unsolicited
Language: Fluent in oral and written English requests.
Education PV HUB Senior Specialist, PV Hub manager deputy

Roche
Zaporizhzhya State Medical
University, Ukraine IPV (International PharmacoVigilance), PD Safety
Sep 2021 - Jun 2022
Medical faculty // 1995 - 2001
Master’s degree in Internal Medicine Fully proficient in all functions and responsibilities of a
PV specialist;
Physician
Support and act as a deputy PV Hub Manager as needed
in defined areas of responsibility, which may fluctuate
Zaporizhzhya Medical Academy according to business need;
of Postgraduate Education, Manages daily workload of Hub unit within the
Ukraine department with limited line management responsibilities;
Collaborates with Local Safety Responsible (LSRs),
Department of Therapy // 2006 - 2008 vendors and other departments in the area of Drug
Сlinical residency in therapy, Safety/Pharmacovigilance, acts as a primary contact for
Clinical resident information regarding assigned tasks and projects;
Liaise with PV Hub manager with regard to resources,
Sertifications timelines and issues with quality, reorganizes daily
workload based on priority, proactively communicates to
Seminar «Standard «Guide. management new issues, offers solutions and reports
Medicine drugs. Good availability to take on new assignments;
pharmacovigilance practices: Trains new staff and mentors less experienced members
review of the new edition», of the team;
UARight, Kyiv // 2018 Acts as the primary resource for other PV specialists with
regards to answering questions, sharing knowledge and
Training «Pharmacovigilance assisting in resolving problems, provide technical
specialist», support;
Pharmagate, Kyiv // 2018 Ensure readiness for Audits & Inspections as well as
effective CAPA development & management relating to
Seminar «Signals in
Hub operational activities. Participate in internal/external
pharmacovigilance system:
audits;
detection, validation, evaluation
Maintains understanding of SOPs, Work Instructions
and reflection in RMP»,
(WIs), global PV regulations, GCPs and ICH guidelines.
UARight, Kyiv // 2018

Training «Clinical studies of
medicines and medical devices»,
Ukrmedcert, Kyiv // 2019
Local Safety Responsible, PV Manager, Local QPPV
Workshop «Good Clinical Practice»,
SEC, Kyiv // 2019
Roche Ukraine LLC, Kyiv, Ukraine
Oct 2018 - Aug 2021
Seminar «Audit of
Pharmacovigilance system of Acting as local contact person for pharmacovigilance and
applicant», local QPPV; qualified PV coverage and processes for
HA of Ukraine, Kyiv // 2019 back-up coverage (including coverage outside of business
hours); monitoring of Affiliate PV system performance and
Training «School of eloquence»,
compliance, and resolving of nonconformities;
Kyiv, Ukraine // 2019
PV training of the Affiliate staff and contractual partners;
Training «Local Safety
Responsible onboarding»,
Roche, Basel // 2019
Sertifications PV business continuity planning and notification of any
incidents that pose a threat locally or globally to
Webinar «Maintaining a pharmacovigilance processes or endanger regulatory
comprehensive and standardized compliance;
database of adverse reactions in Handling of internal PV audits;
accordance with the principles of Ensuring the survey and monitoring of national
ALCOA+», pharmacovigilance regulations and notifying the all relevant
Ukrmedcert, Kyiv, Ukraine // 2021 parties;
Individual Case Safety Report (ICSR) management and
Webinar «HTA and patient`s ICSRs received within the country(ies) covered by the
access to innovative medicines», country operation (receipt, documentation, tracking);
SAFEmed, Kyiv, Ukraine // 2021 Developing and maintenance of local PV SOP and WI;
Review submission rules for Ukraine;
Webinar «Advanced MedDRA
Periodic safety reporting (scheduling, local submissions,
Coding»,
documentation etc.);
MedDRA // 2021
Handling of inquiries relating to product safety including
Training «Health Technology regulatory authority inquiries;
Assessment», Reconciliation of adverse events reports received from other
SEC, Kyiv // 2024 operating units (e.g. Medical Information, product
complaints) and contractual partners, as applicable;
Specialization course Oversight of the Risk Management Plan (RMP)
«Organization and Management Implementation. Contribute to preparation of local RMP and
of the Healthcare System», ensure oversight of its implementation;
Dobrobut Academy, Kyiv // 2025 Consideration of PV matters during locally performed due
diligence activities and negotiate contractual agreements;
Safety signaling activities;
Management DHPC;
Management of Additional Risk Minimization Measure;
Review all projects and approve them from a safety
perspective;
Review and approval of the safety sections/wording and
processes in local commercial agreements to ensure
appropriate training and reporting processes in accordance
with company policies and local regulatory authority
requirements;
Local screening of scientific literature and social media for
safety information;
Oversight of GVP Service Providers/Outsourcing process;
Collection of safety data and other PV-related
responsibilities in relation to organized data collection
schemes (non-interventional studies, pre-approval access
program, compassionate use, registries, patient support
programs, market research programs, etc.)

Summary of product characteristics specialist
Teva, Pharmaceutical company, Kyiv, Ukraine
Mar 2018 - Aug 2018

Preparation Instruction for medical use based on SmPC;
Search medical information;
Negotiation IMU with medical advisors, product managers;
Responding to comments from The State Expert Center of
the Ministry of Health of Ukraine.
Medical editor, deputy head of Medical department
Publish house «Morion», Kyiv, Ukraine
Jun 2009 - Feb 2018

Edit medical and scientific writing and achieve clarity and
precision;
Evaluation and approval of promotional materials;
Participation in conferences;
Scientific search for verifying facts, medical terminology,
tables, figures, citations, etc.;
Work with normative documents;
Organization cooperation with coworkers, other
departments of Company;
Lead medical database and classification (ATC, NFC,
EphMRA, DDD, medical device, cosmetics, equivalence of
medicines, market status of drugs);
Development and implementation classification of medical
device, cosmetics

Сlinical residency in therapy, Clinical resident
Zaporizhzhya Medical Academy
of Postgraduate Education, Zaporizhzhya, Ukraine
Sep 2006 - Jun 2008

Participation in scientific and research working of the
department;
Participation in the development of methodological manuals
for students and doctors;
Advisory work of the department, perform assessment and
review of medical histories;
Participation in scientific and practical conferences and
seminars, analysis of clinical cases;
Monitoring and advising medical students and other junior
doctors.

Attending Doctor
Medical Center «Institute of Problems of Therapy»,
Kyiv, Ukraine
Jun 2008 - May 2009

Attending and Duty Doctor (therapeutic and
neurological departments)
Medical Center «Zaporizhstal», Zaporizhzhya, Ukraine
Sep 2004 - May 2008

Family Doctor
Hospital №8, Zaporizhzhya, Ukraine
Jul 2003 - Aug 2004

Internship in therapy
Zaporizhzhya State Medical University, Ukraine
Aug 2001 - Jun 2003