ANSM (France) Inspections in both materiovigilance and pharmacovigilance.

Transcription

1 Curriculum vitae PERSONAL INFORMATION Olivier Diby WORK EXPERIENCE November 2015 Present Inspector Inspections in both materiovigilance and pharmacovigilance. November 2009 November 2015 MD, Drug Safety Officer BBAC sas (France) Pharmacovigilance, Materiovigilance, Nutrivigilance and Medical information Physician. - Management of a team of 4 drug safety officers, - Managing medical information inqueries, Pharmacovigilance, nutrivigilance and materiovigilance case reports in accordance with regulations and laws in force - Writing case narratives and company comments in both French and English, writing Periodic Safety Update Reports, writing Field Ssafety Corrective Action reports, writing Variations reports about human medicinal product, writing Addendum, Summary and Signal reports, - Making assessment of ADRs based on WHO causality assessment, Naranjo and the French causality assessment, - Editing CIOMS-I, line listing (CIOMS II), Summary Tabulation and xml files, - Weekly literature monitoring in French and international medical database (Medline, Embase and Reactions weekly), - Coding medical clinical data (from spontaneous reports and clinical trials) by MedDRA dictionary, - Quality control of clinical data and case narratives entered in the safety database «Safety-Easy», - Submitting cases to the competent authorities, including reporting of the cases by EudraVigilance web site, - Making Medical review, - Participating to internal and external audits, - Participating to the French Regulatory Agency inspections. February 2008 November 2009 MD, Drug Safety Officer ANTICIPSANTE (France) Pharmacovigilance, Materiovigilance, Nutrivigilance and Medical information Physician. - Managing medical information inqueries, Pharmacovigilance, nutrivigilance and materiovigilance case reports in accordance with regulations and laws in force, - Writing case narratives and company comments in both French and English, writing Periodic Safety Update Reports, writing Field Ssafety Corrective Action reports, writing Variations reports about human medicinal product, writing Addendum, Summary and Signal reports, - Making assessment of ADRs based on WHO causality assessment, Naranjo and the French causality assessment, - Editing CIOMS-I, line listing (CIOMS II), Summary Tabulation and xml files, - Weekly literature monitoring in French and international medical database (Medline, Embase and Reactions weekly), - Coding medical clinical data (from spontaneous reports and clinical trials) by MedDRA dictionary, - Quality control of clinical data and case narratives entered in the safety database «Safety-Easy», - Submitting cases to the competent authorities, including reporting of the cases by EudraVigilance web site, - Making Medical review, 19/2/18 European Union, Page 1 / 5

2 - Participating to internal and external audits, - Participating to the French Regulatory Agency inspections. January 2007 November 2007 MD, Medical data coder PHARMAPPEL (France) - Coding of medical clinical data received from clinical trials, from various therapeutic areas (by MedDRA dictionary, MedDRA Points to Consider, Who Drug Dictionary Enhanced), - Writing coding convention - Editing coded data homogeneization listing, - Making quality control and medical validation and writing coding reports. - Trainer to medical clincal data coding received from clinical trials by using MedDRA and Who Drug dictionaries. January 2005 January 2007 MD, Data Manager UMANIS (France) - Coding of medical clinical data received from clinical trials, from various therapeutic areas (by MedDRA dictionary, MedDRA Points to Consider, Who Drug Dictionary Enhanced), - Writing coding convention - Editing coded data homogeneization listing, - Making quality control and medical validation and writing coding reports. - Paper CRF and ecrf annotation, - Database creation (Clintrial 4.3 client interface and Cleanweb server interface), - Data entry tests and guide, - Database export from CT4.3 to SAS, from SAS/MACRO EXPORT to EXCEL, - Programming SAS Base1, SQL request (SQL PLUS), Database quality control, - Participating to the development of Cleanweb (a clinical research e-crf database). - My suggestions were taken into account by Uppsala Monitoring Centre in 2005, to correct ATC code coding error that I found in the Who Drug dictionary. January 2002 January 2005 Internal medicine Hopital Maison Blanche and Centre Hospitalier de Lagny (France) Care monitoring in geriatry and psychiatry Hospital. January 2000 January 2002 Internal Medicine AGENA (France) Care monitoring in geriatry. January 1999 January 2000 Internal Medicine Hopital Maison Blanche and Centre Hospitalier de Lagny (France) Care monitoring in geriatry and psychiatry Hospital. 19/2/18 European Union, Page 2 / 5

3 EDUCATION AND TRAINING January 2017 February 2017 Inspection of quality risk management: level 2 AFNOR (France) December 2016 December 2016 Analysis of causality in the context of the inspection and risk analysis in the context of the evaluation NEERIA (France) October 2016 October 2016 PhV Inspectors Working Group Training course / European Regulation on amendments to marketing authorization EMA / September 2016 September 2016 Relational dimensions of the inspection / Administrative follow-up of inspections EHESP / June 2016 June 2016 Data integrity in pharmaceutical industry May 2016 May 2016 Penal law / Pharmacovigilance March 2016 March 2016 MedDRA Coding MSSO (France) Training to MedDRA dictionary including safety data coding and SMQ use. - My suggestions will be taken into account by MSSO (in the september release), to correct a coding error that I find in the current version of this dictionary. June 2015 June 2015 My ereport and evereport database administration evedrug (France) Training to My ereport and evereport. March 2014 March 2014 SafetyEasy Advanced Application administration ABCUBE (France) Training to SafetyEasy Advanced Application (Pharmacovigilance database) October 2013 June 2014 University Diploma of Quality Auditor in Pharmaceutical industry Graduated Quality Auditor for auditing. Prepare, conduct and follow-up of audit. Clinical audit, pharmacovigilance audit, Investigator site audit, pharmaceutical company audit, subsidiary and supplier audit, CRO and CSO audit, Computerised systems validation audit (in production and under development), based on Regulatory frameworks and laws in force. 19/2/18 European Union, Page 3 / 5

4 November 2012 November 2012 Materiovigilance skills Seminar / Training: Evolution of the regulation of medical device. October 2012 October 2012 Auditing and inspecting skills Seminar / Training: Audit and Inspection in Pharmacovigilance. May 2011 May 2011 EudraVigilance Medicinal Product data entry skills DIA (France) Training to EVMPD (EudraVigilance Medicinal Product Dictionary) March 2009 March 2009 Monitoring pharmacovigilance adverse effects skills IFIS (France) Training to monitoring pharmacovigilance adverse effects in the literature. November 2007 December 2007 Pharmacovigilance officer For Drug Consulting (France) Pharmacovigilance Physician training. February 2005 February 2005 Medical coder UMANIS (France) Medical Clinical Data Coding Training. September 2004 December 2004 DATA MANAGER SUPSANTE Paris (France) Health Data Manager Professional Training. September 2002 June 2003 European master II Paris V Faculty of Biomedical (France) European Master specialized in health and safety in transport; air transport option. Trainee at Air France and Paris Roissy and Orly Airports. Theme: co-activity. Risk prevention plan performed. September 2001 June 2002 University Diploma in Emergency Medical Help Paris V Faculty of Medicine & Emergency Medical Unit of Paris (France) Emergency Medical Help. September 2000 June 2001 Gerontology skills CNED (France) Training in Gerontology. September 1999 June 2000 Biostatistics skills Paris XI University (France) Training in Biostatistics. 19/2/18 European Union, Page 4 / 5

5 September 1989 June 1998 Medicine Doctor Faculty of Health Science of Cotonou (Benin) Graduated in human médicine. Certificate of post-doctoral education, issued by the Academy of Creteil (France). Certificate of scientific equivalence to the French Doctorate in Medicine, issued by the French Minister of National Education. ADDITIONAL INFORMATION Expertise Publications Projects Memberships Other Relevant Information 19/2/18 European Union, Page 5 / 5