Maria Solonets
Fähigkeiten und Kenntnisse
Werdegang
Berufserfahrung von Maria Solonets
- 4 Jahre und 7 Monate, Apr. 2020 - Okt. 2024
Medical Safety Officer
Johnson & Johnson
- 3 Jahre, Apr. 2017 - März 2020Roche in Switzerland
Medical Director Safety Science, Safety Science Leader / a.i SSL
- 4 Jahre und 2 Monate, Feb. 2013 - März 2017Roche in Switzerland
Safety Scientist/Senior Safety Scientist
- 3 Jahre und 3 Monate, Nov. 2009 - Jan. 2013
Senior Clinical Research Physician
Actelion Pharmaceuticals Ltd
Scientific support to development team with regards to study protocols. Protocol-related trainings (including training of CRO teams). Leading medical review of clinical trials data. Preparation of responses to ECs and HAs. Participation in preparation and conduct of 2 IMs (preparation and review of presentations, presenting). Contribution to trial-related safety monitoring boards (DSMB). Preparation of safety updates for DSMB and HAs.
- 2 Jahre, Nov. 2007 - Okt. 2009
Senior Medical Affairs Manager, Project Manager
Arpida AG
Participation in development of study protocols and protocol amendments. Preparation and approval of study management plans, DVPs, SAPs. Planning and execution of clinical studies in various geographic regions. Scientific support to development team with regards to study protocols. Preparation and conduct of 5 IMs. Contribution to DSMB. Leading medical review of clinical trials data. Review of study reports. QA and QC of trials. Participation in FDA ACs for NDA (back-up slide preparation and management).
- 3 Jahre, Dez. 2004 - Nov. 2007
Project Manager
PSI Pharma Support Intl.
Planning and execution of clinical studies in Romania, Latvia, Lithuania, Poland, Ukraine and Russia. Preparation, review and approval of study management plans. Chair trial-related meetings, report study progress to senior management. Site selection, initiation, coordination of sites monitoring, sites closure. Resources forecast, monitoring and management. Overseeing work of 2 Senior CRAs, 10+ CRAs and 3 PAs. Participation in performance management process.
- 6 Monate, Juli 2004 - Dez. 2004
Senior Clinical Research Associate
PSI Pharma Support Intl.
Contract Research Organization
- 2 Jahre und 4 Monate, Apr. 2002 - Juli 2004
Clinical Research Associate
PSI Pharma Support Intl.
Contract Research Organization
Ausbildung von Maria Solonets
- 1 Jahr und 10 Monate, Sep. 2009 - Juni 2011
European Course in Pharmaceutical Medicine
Basel University
- 1 Monat, März 2009 - März 2009
Project Management
Project Management Institue (PMP Certification Exam Preparation Plus)
- 1 Jahr und 10 Monate, Sep. 1997 - Juni 1999
Residency in Family Medicine
Medical Academy for Postgraduate Education, St. Petersburg, Russia
Cardiology, Internal Medicine, Dermatology
- 5 Jahre und 10 Monate, Sep. 1991 - Juni 1997
Pavlov Medical University, St. Petersburg, Russia
Sprachen
Englisch
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Russisch
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