SG CONSULTING Privatpraxis Integrated Pharmacovigilance & Research Laboratory
SG CONSULTINGPrivatpraxis    Integrated Pharmacovigilance & Research Laboratory 

ISO 9001:2015 Reg. Nr. 731005745

Mitglied der PBV 

Privatärztlicher Bundesverband e.V.

„Hope, vision, and well-being for each patient through integrated clinical practice, education, and research“

Dr. Simona Nistor-Grahl

Double Licensed Postdoctoral Fellow in Molecular Biology & Oncology Research

 

Scientific Title:

Ph.D. in Cell and Molecular Biology - University of Edinburgh, UK

(01/1997 - 12/2000)

 

Professional Summary / Overview:

Molecular biologist and physician with extensive laboratory and academic experience in hematology-oncology and immunotherapy, particularly in the field of nucleic acid research and gene targeting, cell & tissue culture techniques, immunohistochemistry, DNA & patient tissue microarrays. Subspecialized in hematological malignancies, multiple myeloma, metastatic breast cancer, and cell therapies, i.e. dendritic cell therapies for solid tumors, autologous and allogenic stem cell transplantation in various indications; principle scientific advisor for drug development of targeted therapies in oncology; more than five years of scientific consulting for the pharmaceutical industry at local and global directory level on various aspects of pharmacovigilance management; long-term experience as medical reviewer and safety leader for various pharmacological products; safety physician and interim Qualified Person for Pharmacovigilance (QPPV), associate editor for Cochrane Clinical Answers – Oncology & Hematology; EU GMP interdisciplinary advisor for the production, writing, review, and update of the IMPD Dossiers for therapeutic dendritic cells for use in oncology trials (phases I and IIa/b), including all implied Chemistry, Manufacture and Control (CMC) and Change Control review activities; Product Quality Reviewer (PQR) for biopharmaceuticals, participant in preparatory meetings for GMP inspections and ongoing risk/benefit analysis; corporate SOP editor for process interfaces with pharmacovigilance, regulatory affairs and production, including third party qualification and management; certified in EU GMP & cleanroom technology, solid knowledge of the ICH GCP, GLP, GVP Guidelines, and of the German and EU Bio-manufacturing Guidelines; expert in MedDRA coding of adverse events; solid experience in collection and evaluation of individual case safety reports (ICSRs) from the German market for a wide range of pharmaceutical/medicinal products; expert in ICSR case processing and answering to medical-scientific enquiries from healthcare practitioners or patients, and in SUSARs evaluation and E2B reporting; responsible for answering to pharmacovigilance (PV) authority requests; expert in critical appraisal of medical & scientific literature for pharmacovigilance, and local monitoring in the post-authorization phase for various Active Pharmaceutical Ingredients (APIs), generation and writing of cumulative, global safety reports (e.g. PSURs, PBRERs) according to the Good Pharmacovigilance Practice (GVP) - Modules VI, VII and IX, including interpretation of the aggregate data, qualitative and quantitative evaluation of the risk/benefit of medication in various patient populations; experienced in generation, writing and update review of various European Risk Management Plans (RMPs) according to the GVP Modules V and VI; peer-reviewer and advisor for the generation of Development Safety Update Report (DSUR) for ongoing clinical studies; local contact person for the German Competent Authorities on pharmacovigilance matters, i.e. Federal Institute for Drugs and Medical Devices, i.e. German Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Paul Ehrlich Institute, and Drug Commission of the German Medical Association, i.e. German Arzneimittelkommission der deutschen Ärzteschaft (AkdÄ).

 

Licenses and Awards:

Research Fellow of the Darwin Trust of Edinburgh (01/1997 – 12/2000)

Research Fellow of the Mayo Clinic Rochester, MN, USA (03/2001 – 10/2002)

 

 

Druckversion Druckversion | Sitemap
© SIMONA GRAHL CONSULTING

Erstellt mit 1&1 IONOS MyWebsite.