Специалист по фармаконадзору/Руководитель отдела

Описание

Tatiana Sokolova

Mobile: +79096455830
sokolovat@mail.ru
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EMPLOYMENT HISTORY

From - to:

09 Jun 2022- present Swixx Healthcare a Swixx Biopharma Company, Moscow 
Manager Drug Safety and Risk Management

Manage to case processing for partners (BMS and Sanofi), contribute to perform local educational material implementation in KAZ, manage to annual risk benefit reports for termless registration certificates of Sanofi products, manage to monthly reports submission of F/LT cases for both BMS and Sanofi products in Kaz, act of back up of Kaz Belarus PV representatives.


01 Mar-2020-09 Jun 2022: Celgene International Holdings Corporation, Moscow

Manager Drug Safety and Risk Management

ICSR management, Clinical ICSR management, Post-marketing ICSR management, Risk minimization, Pre-approval Access, Management and oversight of locally led data collection, Provide PV safety reporting training to Investigator meeting, Support continuous Inspection and Audit readiness and support successful and timely responses to CAPAs, Regulatory Authority Interactions, Routine PV activities : report any potential safety issue in a timely manner, Provide AE and RMP training to local staff/third parties, participate in Product Quality Complaint interactions , participate in Medical information interaction, Manage to local literature review, Manage to local legislation review, AE reconciliation with stakeholders, Contribute to local SOP& WPs development and management, Act as back up DSRM Manager, Contribute to GDSRM/GDSRM EMEA ARAC led initiatives & projects as required.



01Oct 2019-01Mar2020 Celgene International Holdings Corporation, Moscow
Associate Drug Safety Manager

ICSR management, Clinical ICSR management, Post-marketing ICSR management, Risk minimization, Pre-approval Access, Management and oversight of locally led data collection, Provide PV safety reporting training to Investigator meeting, Support continuous Inspection and Audit readiness and support successful and timely responses to CAPAs, Regulatory Authority Interactions, Routine PV activities : report any potential safety issue in a timely manner, Provide AE and RMP training to local staff/third parties, participate in Product Quality Complaint interactions , participate in Medical information interaction, Contribute to local literature review, Contribute to local legislation review, AE reconciliation with stakeholders, Contribute to local SOP& WPs development and management, Act as back up DSRM Manager.

01 Mar-2017- 01Oct 2019 Celgene International Holdings Corporation, Moscow
Senior Drug Safety Specialist

Management of the case processing function including receipt, assessment, and reporting of Adverse Events from both clinical trials and post-marketing experience in compliance with Federal, European, Country and International Regulations and Celgene’s Standard Operating Procedures and Work Practices.

09 Jul 2015- 01 Mar-2017 Celgene International Holdings Corporation, Moscow
Drug Safety and Regulatory Specialist

Management of the case processing function including receipt, assessment, and reporting of Adverse Events from both clinical trials and post-marketing experience in compliance with Federal, European, Country and International Regulations and Celgene’s Standard Operating Procedures and Work Practices.


02 Jun2015-09 Jul 2015 Manpower for Celgene International Holdings Corporation, Moscow
Drug Safety and Regulatory Specialist

Management of the case processing function including receipt, assessment, and reporting of Adverse Events from both clinical trials and post-marketing experience in compliance with Federal, European, Country and International Regulations and Celgene’s Standard Operating Procedures and Work Practices.


Aug 2013-02 Jun 2015 Sanofi-Aventis group, Moscow
Pharmacovigilance specialist

Medical review of ADR, submit all reportable ADR to Russian HA, AWARE data base handling, PSUR submission, SUSAR submission, PV training for newcomers (non-safety employees and vendor) Cycle meeting preparation.

Nov2012-Aug2013 Covance for Sanofi-Aventis group, Moscow
Clinical Trial specialist

Site selection, initiation, monitoring visits to clinical centers and close out of study (II-III phase). Audit preparation and
Clinical Trials were related to Cardiology and Endocrinology disease.

Jan2012-Nov2012 Crocus Medical for Sanofi-Aventis group, Moscow
Clinical Trial specialist

Site selection, initiation, monitoring visits to clinical centers and close out of study (II-III phase). Audit preparation and
Clinical Trials were related to Cardiology and Endocrinology disease.

May2011-Jan2012 ZAO “Generium”, Moscow
Clinical Research Associate

Jul2010-May2011 Quintails GesmbH, Moscow
Clinical Research Associate

Dec2006-Jul2010 ICON, plc, Moscow
Clinical Research Associate

EDUCATION

13 Feb 2020- FGBU” Science center of expertise of medical product” GVP, QPPV work organization (foundation course)

2018-2020: High Shcool of Economic special cource of MBA Pharmacy, Moscow.

08 June 2018 -FGBU” Science center of expertise of medical product” GVP, QPPV work organization (advanced course)

2003-2005: Postgraduate special course at Russian Cardiology Research Center named afer Myasnikov, Moscow, Cardilogist

1996-2003: Chelyabinsk State Medical Academy, Medical Doctor, General Practioner


PERSONAL

(English intermediate, Russian-native)