Анна

ANNA BASTRYKINA
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Medical doctor with 10 years of both clinical and pharmaceutical
industry experience, specializing in pharmacovigilance oversight
and regulatory compliance.
My expertise lies in monitoring AE, SAE reconciliation,
conducting benefit-risk assessments, preparing safety
documents, managing CRO relationships and collaborating with
regulatory authorities.

KEY SKILLS
• Medical literature monitoring • Signal detection and benefit-risk assessment
• Adverse events coding • Regulatory submissions
• SAE reconciliation • Cross-functional teamwork
• Medical writing • Excellent computer skills
EXPERIENCE
Dec 2022 – Associate Manager Preclinical Development
Dec 2023
Immunic AG, Gräfelfing, Germany
• Participated in selecting Contract Research Organizations (CROs) and
provided comprehensive support for contracted preclinical pharmacology,
safety (toxicology), and PK/PD studies in collaboration with CRO.
Responsibilities included study design, protocol development and review,
and management of reports.
• Responsible for collecting relevant data for environmental risk assessment.
• Identifying and translating potential safety and toxicological findings from
preclinical studies into clinical scenarios.
• Conducting research on science-related information and providing opinions
on requested topics.
Apr 2022 – Manager Pharmacovigilance
Dec 2022
Immunic AG, Gräfelfing, Germany
• Manage relationships and acting as a prime contact for CRO/vendors.
Overseeing the activities, incl. case processing, performed by vendors.
Performs safety data reconciliation.
• Role of Sponsor’s Unblinded Person.
• Ensuring oversight and accuracy on medical evaluations of case reports.
• Participating in the review of clinical safety documentation (study protocols,
investigator brochures, TMF).
• Staying up to date with updates of guidelines and regulators’
recommendations. Supporting regular update of SOPs in accordance with
regulatory requirements.
• Organization and contribution of DSURs to submission.
• Proactively identifies areas of potential improvement and process
optimization and suggests potential solutions.
Nov 2021 – Lead Specialist of the Pharmacovigilance and medical
Mar 2022 instructions group
Pharmaceutical company Darnytsia, Kyiv, Ukraine
• Contributed to the smooth functioning of the PV system and ensured
compliance with regulatory requirements (Deputy QPPV role).
• Oversaw daily workflow monitoring and management of incoming and
outgoing Individual Case Safety Reports.

Nov 2018– Specialist of the Pharmacovigilance and medical instructions
Oct 2021 group
Pharmaceutical company Darnytsia, Kyiv, Ukraine
Risk minimization activities, including additional risk minimization
activities:
• Medical literature monitoring.
• Managing an internal PV database: the collection, storage and analysis
safety data.
• Support daily workflow monitoring and managing of incoming and outgoing
ICSRs.
• Conducting benefit-risk assessment.
• Writing SmPC, RMP, ACO, PSUR and other PV documents for registration,
renewal of marketing registrations and for procedures making changes in
dossier materials.
Safety labeling changes:
• Updating a safety labeling based on the new information found.
• Proofreading labelling materials (package insert and labels).
Activities behind:
• Communication with other departments and the National regulatory
authority.
• Entering documents into the database in CTD format. Storage and updating
documents.
• Monitoring of PV legislation.
• Updating SOPs and the Master File in accordance with regulatory
requirements.
• Participation in audits.
Aug 2014– Medical psychologist
Oct 2018
Kyiv City Psychoneurological Hospital, Kyiv, Ukraine
• Conducting primary counseling and diagnostics of the military, working
with patients with mental illnesses from childhood to gerontology.
• Describing the mental processes of patients through experimental
psychological techniques and writing pathopsychological conclusions.
• Making the differential diagnosis.
• Forming and conducting art therapy groups.
• Maintaining necessary medical documentation.
 Aug 2013– Medical psychologist • Internship
Jul 2014
Kyiv City Psychoneurological Hospital No 1, Kyiv, Ukraine
Received training from the clinical psychology staff and gained practical
experience by observing and assisting with the work performed: initial
consultations, psychological testing and report writing.

EDUCATION
Medical doctor – MD, Physician, specialization in medical psychology
Bohomolets National Medical University |
Kyiv, Ukraine | Finished in June 2013

LANGUAGES
English – Advanced Ukrainian – Mother tongue
German – Intermediate (B1) Russian – Fluent

SPECIAL PV QUALIFICATION/COURSES ATTENDED

Training Pharmacovigilance in Clinical Trials, SCRATCH Pharmacovigilance,
Butzbach, Germany, 03 and 17 Nov 2022

Education course – “Fundamentals—Pharmacology”, HMX Office of Online Learning
Harvard Medical School, Boston, USA, 11 Jan‒25 Mar 2022

Learning courses provided by DIA, Drug Information Association, Horsham, The United
States:
• Basic Safety Sciences: Pharmacoepidemiology, Clinical Pharmacology,
Pharmacogenomics, and Toxicology Studies. 21 Oct 2022
• Safety Audits and Inspections. 20 Oct 2022
• Basics of Signal Detection and Pharmacoepidemiology. 06 Oct 2022
• Post-Marketing Safety Management. 22 July 2022
• Pre-Marketing Clinical Trial Safety. 15 July 2022
• Drug Safety Regulatory Requirements. 15 June 2022
• Introduction to Drug Safety. 5 May 2022

Webinars provided by MedDRA MSSO:
• What is MedDRA and how is it used? 21 Sept 2023
• Let’s Code Together. 19 Sept 2023
• Coding of Medication Errors - General Principles. 29 Aug 2023
• What’s New with MedDRA V26.1. 23 Aug 2023
• MedDRA Coding Basics. 10 Aug 2023
• Advanced MedDRA coding. 27 Jul 2023

Courses provided by Uppsala Monitoring Centre:
• Clinical diagnosis of adverse drug reactions. 31 Aug 2023
• Drug induced liver injury. 28 Aug 2023
• PV management systems and terminologies. 21 Aug 2023