Sofiya Radeva

Experience

• 

  Private Medical Centre Prevent

  Jan 2007 - Aug 2008

  Specialist Obstetrician and Gynaecologist

  Management of O&G patients

• 

  Bulgarian Drug Agency

  Mar 2012 - Jul 2013

  • Assessment of the documentation submitted for authorization to conduct clinical trials (CT)/non-interventional trials of medicinal products • Assessment of the documentation submitted for authorization in case of a substantial amendment to authorized clinical trials of medicinal products • Issue of Authorization to conduct pharmaceutical clinical trials • Issue of Authorization to Non-interventional trials• Issue of addendum to the Authorization in case of a substantial amendment • Performing GCP inspections of the CT sites and ethics committees • Proposing to the Executive Director the suspension or termination of CT on medicinal products in case of violations • Keeping and maintaining records according to art. 19, para. 1, item 6 and Art. 103, para. 3 LMPHM. • Working with European Data Base (EudraCT and EudraVigilance)  EudraCT:o Entering and editing data about ongoing clinical trials in Bulgariao Entering and editing data about the proposed substantial amendments EudraVigilance:o Reviewing and sending acknowledgments of the received SUSAR reports from clinical trials ongoing in Bulgaria Show less • Assessment of the documentation submitted for authorization to conduct clinical trials (CT)/non-interventional trials of medicinal products • Assessment of the documentation submitted for authorization in case of a substantial amendment to authorized clinical trials of medicinal products • Issue of Authorization to conduct pharmaceutical clinical trials • Issue of Authorization to Non-interventional trials• Issue of addendum to the Authorization in case of a substantial amendment • Performing GCP inspections of the CT sites and ethics committees • Proposing to the Executive Director the suspension or termination of CT on medicinal products in case of violations • Keeping and maintaining records according to art. 19, para. 1, item 6 and Art. 103, para. 3 LMPHM. • Working with European Data Base (EudraCT and EudraVigilance)  EudraCT:o Entering and editing data about ongoing clinical trials in Bulgariao Entering and editing data about the proposed substantial amendments EudraVigilance:o Reviewing and sending acknowledgments of the received SUSAR reports from clinical trials ongoing in Bulgaria Show less

  • Chief Inspector, Clinical Trials Department

    Oct 2012 - Jul 2013

  • Junior Inspector

    Mar 2012 - Oct 2012
• 

  Pfizer

  Jul 2013 - Feb 2016

  Medical Advisor

  Medical Advisor - Oncology

• 

  IQVIA

  Feb 2016 - May 2019

  Associate Medical Director
• 

  PRA Health Sciences

  May 2019 - Aug 2020

  Medical Director
• 

  EastHORN

  Sept 2020 - now

  • Executive Medical Director

    Oct 2023 - now

  • Senior Medical Director

    Mar 2021 - Sept 2023

  • Medical Director

    Sept 2020 - Feb 2021