Aude ANTIGNAC

En résumé

Entreprises

• AB Science - Senior Drug Safety Officer - Deputy veterinary QPPV

  2013 - 2018 Therapeutic areas: oncology, neurodegenerative, inflammatory diseases
  
  Clinical trials (human and veterinary)
  - Processing of Serious Adverse Events (SAE) and Adverse Events of Special Interest (AESI): reception, triage, assessment, data entry in the database, narrative, quality check, request for additional information, SUSARs and AESI reporting and diffusion
  - SUSAR submission to Eudravigilance (EVWEB)
  - Preparation of MedWatch and CIOMS I forms
  - Data reconciliation between PV and clinical databases
  - Safety periodic report writing (DSUR, 6-month line listing of SUSARs, IDMC reports…), Investigator Brochure and other ad-Hoc regulatory documents
  - Writing and update of SOP, working instructions, forms
  - Answers to ad-Hoc requests for safety evaluations from worldwide competent authorities and ethics committees
  - Answers to ad-Hoc safety requests from the clinical study teams and investigational sites
  - Review of the safety parts of clinical study protocols, ICF, CRF, reports, other regulatory documents
  - Collaboration with Clinical Operations, Clinical Project Management, Statistics, and Data Management
  - Pharmacovigilance training of internal colleagues and contracted partners, review of training material, Eudravigilance training
  - Mentoring of trainees and junior DSOs
  - Participation in periodic IDMC (Independent Data Monitoring Committee) meeting
  - Participation in periodic project meeting with other departments (clinical project managers, data managers, medical reviewers, and statisticians)
  - Working in compliance with worldwide health authority drug safety regulations and guidelines, company policies and procedures, clinical protocols, and industry standards
  - Preparation and participation in EMA, FDA, ANSM inspections and audits
  - Deviation and CAPA writing following inspections, audits
  
  Post-marketing (veterinary)
  - Processing of AEs (Adverse Events): reception, triage, assessment, data entry in the database, narrative, quality check, request for additional information, expedited reporting to competent authorities according to legislation
  - Submission of AEs to Eudravigilance (EVVET)
  - Data reconciliation between PV and quality complaint databases
  - PSUR/PBER schedule maintenance and submission to competent authorities
  - Safety periodic report writing (PSUR/PBER) and other ad-Hoc regulatory documents
  - Answers to ad-Hoc requests for safety evaluations from competent authorities
  - Weekly literature searches, review, and identification of AEs
  - Review of SDEA (Safety data Exchange Agreement)
  - Collaboration with sales representatives, pharmaceutical operations, regulatory affairs departments
  - Pharmacovigilance training, review of training material, Eudravigilance training
  - Writing and update of SOP, working instructions, forms
  - Compliance monitoring
  - Update of the DDPS (Detailed Description of the Pharmacovigilance System)
  - Preparation and participation (leader) in EMA inspections
  - Deviation and CAPA writing following inspections

• Takeda France, Paris - Drug Safety Officer - Post-marketing (human)

  SURESNES 2011 - 2013 Therapeutic areas: oncology, cardiovascular, gastrointestinal diseases
  
  - PV case processing (reception, triage, assessment, data entry in the database, narrative, quality check, request for additionnal information, submission to the corporate)
  - Validation of CIOMS I forms received from the corporate
  - Collaboration with internal departments (corporate, sales representatives, market research, pharmaceutical affairs, medical direction) and external (ANSM, CRPV, subcontractors)
  - Management of a product with a risk management plan
  - Review of the requests/complaints received by the medical information department, quality department, subcontractors and reconciliation
  - Review of the weekly literature search and identification of ICSRs
  - Preparation and update of forms, working instructions, SOP
  - PV training of staff
  - Preparation of activity reports
  - Validation testing before go-to-production of a new PV data base NAYA
  

• For Drug Consulting, Malakoff - Drug Safety Officer Trainee

  2011 - 2011 - French and European legislation
  - Reception, triage, redaction of narratives, company comments, French and international imputability (WHO - assessment), documentation of PV cases
  - Data Entry and queries in the PV database Safety easy, MedDRA coding
  
  

• Institut Pasteur, Paris - Chercheur en Microbiologie

  Paris 2009 - 2011 Unité des Infections Bactériennes Invasives – Centre National de Référence des Méningocoques dirigés par Muhamed-Kheir TAHA
  
  Etude fonctionnelle des protéines liant la pénicilline de Neisseria meningitidis

• The Rockefeller University, New York City, USA - Chercheur en Microbiologie

  2004 - 2009 Laboratory of Microbiology and Infectious Diseases dirigé par Alexander TOMASZ
  
  -Analyse structurale de la paroi bactérienne et étude fonctionnelle des protéines liant la pénicilline des souches de Staphylococcus aureus et Staphylococcus sciuri sensibles et résistantes aux ß-lactamines
  -Régulation de la biosynthèse de la paroi et lyse bactérienne chez Staphylococcus aureus
  -Comparaison du déterminant de résistance aux ß-lactamines mecA des souches de S. aureus résistantes à la méthicilline (SARM) et de son homologue chez S. sciuri
  -Activité in vitro de nouveaux antibiotiques contre les souches de SARM

• Institut Pasteur, Paris - Chercheur en Microbiologie

  Paris 2003 - 2003 Unité des Neisseria – Centre National de Référence des Méningocoques dirigé par Jean-Michel ALONSO
  
  -Etude de la protéine liant la pénicilline 2 (PBP2) comme candidat-vaccin contre les infections méningococciques
  -Participation à une étude de surveillance des méningites bactériennes au Burkina Faso par approche PCR

• Institut Pasteur, Paris - Doctorant

  Paris 1999 - 2003 Unité des Neisseria– Centre National de Référence des Méningocoques dirigés par Jean-Michel Alonso
  
  - Analyse épidémiologique, moléculaire, structurale et fonctionnelle des souches de N. meningitidis de sensibilité diminuée à la pénicilline
  - Mise au point de techniques moléculaires pour la détection de l’antibiorésistance chez N. meningitidis
  - Participation à une étude de surveillance des méningites bactériennes au Burkina Faso par approche PCR
  - Etude de la protéine liant la pénicilline 2 (PBP2) comme candidat-vaccin contre les infections méningococciques
  

• CHU, Rennes, Service de Bactériologie, Virologie et d’hygiène hospitalière - Faisant Fonction d’Interne

  1998 - 1998 Collaboration aux Observatoires Régionaux du Pneumocoque (ORP): Epidémiologie et résistance aux antibiotiques des souches de Streptococcus pneumoniae isolées en Bretagne

Formations

• For Drug Consulting

  Malakoff 2011 - 2011 Certificate in Pharmacovigilance
  
  
  

• Université Paris 7 Denis Diderot

  Paris 1999 - 2003 Doctorat en Microbiologie

• Université Paris 7 Denis Diderot

  Paris 1998 - 1999 Bactériologie médicale

• Université Rennes 1

  Rennes 1992 - 1998 Doctorat de pharmacie

• Lycée Saint Vincent Providence

  Rennes 1989 - 1992 bac C

Réseau

• Bruno VILLAIN

• Candice REITER

• Christine BRENOT

• Joséphine DIBAYA

• Julien BAUDIER

• Pandora MOTELEY

• Pascal BRUN

• Samia ALLAB

• Sidonie MORALÈS

• Thibaut LALLEMENT