Petra Hosekova

Comprehensive monitoring activities for a prospective, observational, non-invasive, non-interventional, open, non-randomised trial.

Reporting all events and endpoints appropriately to Sponsor. Completion and maintaining the site file, inventory of study supplies, Investigational Drug/Device Accountability.Working with PI to manage the day to day activities of the study, including problem solving, communication, and study procedures management.Effective and ongoing communication with the sponsor .

Monitoring of non-interventional studies - post registration and observational projects, ,supervising the ongoing Phase III studies conducting by CROs, RA submission.

•Ensure timely and accurate handling of domestic Adverse Event r and follow-up eports with marketed products. •To report events appropriately to Company Pharmacovigilance Department in accordance with company SOPs •Following local drug safety reporting requirements, monitoring of current local pharmacovigilance legislation •Periodical literature and reports review.

• Perform routine site visits, including pre-study, initiation, interim, and closeout visits. • Visits to include monitoring of proper informed consent procedures, compliance with protocol,GCP/ICH Guidelines and other applicable regulatory requirements and assurance of good site performance. • Perform unblinded pharmacy monitoring. • Regulatory submission, site contract negotiation,ICFs, patients materials review, essential documents collection and review. • Perform feasibilities in various areas.

• Medical information: -training of the new medical representatives, review and check of the promotional materials • Regulatory affairs: - preparation and submission of the application forms and dossiers for new registrations, variations and renewals,labells texts review • Pharmacovigilance -Ensure timely and accurate handling of domestic Adverse Event r and follow-up eports with marketed products. • Clinical research Regular contact with external CRO by the supervision of the ongoing clinical trial.

- Medical practice within the postgraduate education.

General medicine