Daria Saenko
Senior Medical Director, (oncology and hematology), USA certified in Medical Monitoring, Pharmacovigilance and Regulatory Affairs
- Role
- Senior Medical Director at ICON plc
- Location
- Chapel Hill, NC, US
- LinkedIn followers
- 500 followers
About Daria Saenko
As a performance-driven and strategic professional, I have great experience in conducting…
Experience
Senior Medical Director
Apr 2024 — Present · US
review eligibility data- study drug exposure- AE/SAE reports, compose/assess AE/SAE narratives, address unresolved safety queries- interact with the CRO/investigators regarding on-site safety concerns- fixing project-specific medical and safety inquiries, including regulatory agencies and independent ethics committees- manage ongoing project risks associated with medical monitoring, review protocol deviations, and track safety-related reportsSelected Accomplishments: Revised essential study documents with updates/amendments, evaluated Safety Reports for IND/SUSAR, and compiled annual IND reports incorporating sponsor data as requested by the sponsor. Integrated data management and PVG while reconciling safety and operational clinical trial databases. Led the provision of physician-level opinions across various trials and sites, distinguishing from the traditional role of a physician principal investigator focused solely on site-specific trials. Warranted continuous monitoring of patient safety and engaged in subject recruitment enhancement and retention initiatives. Maintained a comprehensive overview of study documents involving study protocols, amendments, IB, and IC. Delivered training to the project team on medical aspects of protocols and therapeutic areas. Developed and analyzed essential plans, such as the Medical Monitoring Plan (MMP), Safety Management Plan (SMP). Daily work with deviations from the protocol, analysis of information on safety.
Education
Training Course in Clinical Pharmacology, Leningrad Regional Clinical Hospital, St. Petersburg, Russia
Clinical Pharmacologist, Clinical Pharmacology
2003 — 2003
Training Course in GCP, PSI Co. Ltd., St.Petersburg, Russia
CRA, clinical trials
2005 — 2005
CCRPS
NA, Pharmacovigilance and Regulatory Affairs
Saint Petersburg State Medical University
upgrade course in oncology , Medicine
, St. Petersburg State Medical Academy of Postgraduate Education, St. Petersburg, Russia
Doctor of Medicine - MD, intrenal diseases
1999 — 2002
St. Petersburg State Pediatric Medical Academy, St. Petersburg, Russia
Internist , Internal Diseases
1993 — 1999
Course in oncology, St. Petersburg State Medical University named Pavlov, St. Petersburg Russia
Oncologist, Chemotherapy
2012 — 2012
CCRPS
Advanced Physician Medical Monitor Certification (APMMC), Clinical/Medical Laboratory Science/Research and Allied Professions
Harvard University
Clinical Development Strategies
GCP R2 training, Pfizer, Inc
Clinical Tirals
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