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Maria STEFANOVA

Castres

En résumé

Corporate Pharmacovigilance Physician Oncology
Medical doctor with speciality in biochemistry / molecular medicine and 17-years experience in translational cancer research. Research Postdocs at MSKCC, New York; Institut Gustave Roussy, Villejuif; INSERM - Institut Paoli Calmette, Marseille

Special area of expertise:
Oncology-related signal transduction and targeted therapies;
Pharmacovigilance and development of oncology drugs: polychemotherapy and combinations with tyrosine kinase and angiogenesis inhibitors;
Investigator Initiated Trials safety management (incl. combinations cytotoxics - targeted therapies)

Corporate Pharmacovigilance Physician Oncology, Pierre Fabre, France (2006 - Present)
Manage all aspects of the pre- and post-marketing safety of Navelbine at national & international level: expedited reporting and periodic reports (PSUR, DSUR, Brief, SBR, NIT). Ensure compliance of ICSRs.
Evaluation of Benefit / Risk, signals, alerts, conducting enquêtes.
Working on a targeted-therapy product in early development.
Managing IITs exploring combinations of cytotoxic and targeted therapies.
Interactions (inspections, CAPA, enquêtes) with Competent Authorities (European and Worldwide).
Working groups on the novel PSUR, periodic reports, transversal activities.
Elaborate documents needed for MA registration & renewal: Clinical Overviews, Expert Statements. Review Summary of Clinical Efficacy, Summary of Clinical Safety, Final Study Reports, new Study Protocols, Informed Consents, Investigator Brochure.

European Pharmacovigilance Physician, CHIRON, London (2005-2006)
Assist the Head of European Pharmacovigilance & QPPV to develop and maintain the European Pharmacovigilance System. MHRA inspection.
Supervise, coordinate and audit affiliates throughout Europe.
Represent Pharmacovigilance on the Drug Safety Committee of CHIRON and at external meetings.
Worked as Pharmacovigilant at Eli Lilly, Boehringer Ing.(France).
Research Associate of Biochemistry at the National Center of Oncology, Sofia.
Teaching biochemistry to medical students (Medical Academy, Bulgaria).
Trilingual: English, French, Bulgarian
Nationality: French and Bulgarian

Mes compétences :
Drug safety
Médical
Pharmacovigilance
Research
Safety

Entreprises

  • Pierre Fabre - Corporate Oncology Pharmacovigilance Physician

    Castres 2006 - maintenant Manage all aspects of the pre- and post-marketing safety of Navelbine at national & international level: expedited reporting and periodic reports (PSUR, DSUR, Brief, SBR, NIT). Writing personally most of the periodic reports.
    Oversee a team of PV associate and two PV assistants to ensure compliance of spontaneous and clinical research cases: data-entry, f-up info, medical evaluation, declaration to Competent Authorities, affiliates and partners.
    PSUR Work-sharing Procedure (2009, 2012) with updating of the Core Safety Profile, the CCDS and the EU SPCs.

    Evaluation of Benefit / risk, signals, alerts and conduct of enquêtes.
    Working on a targeted therapy product in early development.
    Managing IITs exploring combinations of cytotoxic and targeted therapies.

    Interactions (inspections, CAPA, enquêtes) with Competent Authorities (European and Worldwide). Participation in external and internal audits.
    Working groups on the novel PSUR, periodic reports, transversal activities.
    Writing Narrative Templates (corporate) and establishing the workflow for my group.

    Coordination of partners - negotiation and review of SDEA, compliance check-up.
    Liase with affiliates: overview of their activities, update on safety information, answering diverse questions, aid with renewals, local SPC updates, case processing in ARGUS and requests from their respective Competent Authorities.
    Training and supervision of junior pharmacovigilants from affiliates.

    Update and harmonize, together with Regulatory Affairs, the CCDS, SPCs, PILs.
    Elaborate documents needed for MA registration & renewal: Clinical Overviews, Clinical Expert Statements, relevant parts of Type II variations, RMP exemptions.

    Review Summary of Clinical Efficacy, Summary of Clinical Safety, Final Study Reports, new Study Protocols and amendments, Informed Consents.
    Review annually the Investigator Brochure. Participate in R&D / RA / PV meetings.

  • IVS, Paris - Research physician (translational research, R&D)

    2005 - 2005 Translational research on the antiangiogenic properties of a new molecule to be used alone or in combinations for treatment of melanoma and a panel of selected solid tumours (R&D collaboration with a pharmaceutical lab).

  • Chiron, London, UK - European Pharmacovigilance Physician

    2005 - 2006 Assist the Head of European Pharmacovigilance & QPPV to develop and maintain the European Pharmacovigilance System.
    Register, document, validate and transfer to Global Drug Safety spontaneous and clinical-trial initial & follow-up ADRs. Declare ADRs to EMEA, MHRA & IMB within required timeframes. Proactively seek additional information and provide medical expertise. Spot possible trends and changes in safety profiles and act accordingly.
    Supervise, coordinate and audit affiliates throughout Europe.
    Represent the Department of Pharmacovigilance on the Drug Safety Committee of CHIRON and at external meetings.

  • Dept. Pharmacovigilance, Eli Lilly, Suresnes, France. - Drug Safety Associate

    2003 - 2004 Postmarketing case management (processing, medical evaluation, reporting) and drug safety information - Central Nervous System and Endocrinology. Responses to health-care professionals. Quality control and medical input in the Safety meetings.
    Drug safety for oncology products: Compassionate Study (ATU) and Investigator Initiated Trials (IITs). Work on dossier “Transparence” for a MA of a new product.

  • Boehringer Ingelheim- France. - Drug Safety and Scientific Affaires Project Leader

    2001 - 2003 Processing (S)AEs for all marketed and some trial drugs: reviewing data entry, MedDRA coding, writing narratives, assessing expectedness & causality in ARISg.
    Reporting SAEs to Regulatory Authorities and licensee partners.Managing queries, requests and medical information for all BI drugs.
    Elaborating a signal transduction network model to explain the molecular pharmacology (mechanisms of action, efficiency, toxicity, interactions) of a new BI product to strengthen its MA application & confirm positive benefit/risk assessment.

  • Biologie Industrie, Paris - Clinical Research & Pharmacovigilance training

    2000 - 2001 Processing of clinical trial adverse event reports for Phase III in cardiology, queries, follow-ups. Reconciliation drug safety vs CRFs and correction of drug codes for a PASS in psychiatry. Monitoring visits (initiation, closure, on-going).

  • Génétique des Cancers, Institut Gustave Roussy, Villejuif - Translational Research - Oncology

    1998 - 1999 Studying expression & differential transcription of p73 in a panel of neuroblastomas. Establishing protocols for RT-PCR and demonstrating differences in expression and alternative splicing according to differentiation status and responses to cytotoxics.

  • Memorial Sloan-Kettering Cancer Center, New York, USA - POSTDOC: Molecular Oncology (ovarian cancer)

    1991 - 1993 Molecular Oncology (ovarian cancer) – Immunology program, Memorial Sloan-Kettering Cancer Center, New York, USA
    Construction and immunoscreening of ovarian cancer cDNA libraries (based on ascites primary cultures and established cell lines) in order to expression-search for novel mucin genes. Design of RT-PCR protocols to study clinico-pathological correlations between MUC2 and behavior of ovarian cancer. Teaching technicians.
    Writing research projects (for grants) on signal transduction in human malignancy.
    Poster Award in the AACR/JCA joint Conference1992.
    Participation in the joint meetings of the Gynecologic oncology.

  • Unité 119 INSERM, Institut Paoli-Calmette, Marseille - Postdoc-Molecular Biology (oncogenes)

    1989 - 1990 –
    Screening cDNA libraries, isolation, restriction mapping, partial sequencing of URS – gene fragment activating the mcf2/dbl oncogene. Journal clubs.

  • National Center of Oncology, Sofia, Bulgaria. - Research Associate in Biochemistry

    1988 - 1997 Inhibition of gastric and colon carcinogenesis in rats by different combinations of selenium, NSAIDS and synthetic retinoids. Testing MUC2 expression and K-ras mutations as molecular markers of tumour progression.
    Giving courses on molecular oncology for researchers and clinicians. Help with writing grants and scholarship demands. Presentations at seminars on signal transduction in human malignancy – principles and clinical implications.

  • Dept. of Biochemistry, Medical Academy (Stara Zagora) Bulgaria - Assistant Professor of Biochemistry

    1985 - 1988 Teaching general and medical biochemistry (molecular medicine) to medical students, supervising their laboratory sessions and assistance in exams.
    Studying the cytotoxicity and kinetics of spin-labeled nitrosoureas

  • General City Hospital, Rousse, Bulgaria - General physician and Resident in Internal Medicine

    1983 - 1985

Formations

Pas de formation renseignée

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