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Aude ANTIGNAC

RENNES

En résumé

SENIOR PHARMACOVIGILANCE SPECIALIST, PharmD, PhD
Pre- and post-marketing (human and veterinary)
Registered at ordre national des pharmaciens – B section
6.5 years of experience in pharmacovigilance

KEY SKILLS
- Ability to work independently and in a multidisciplinary and multicultural team
- Working in compliance with worldwide health authority drug safety regulations and guidelines, company policies and procedures, clinical protocols, and industry standards
- PV case management pre- and post-marketing authorization (human and veterinary)
- MedDRA coding
- Data reconciliations between PV and clinical, quality complaints, medical information departments, subcontractors
- Safety report writing
- SOP and working instruction writing and update
- Answers to ad-Hoc safety requests from competent authorities, ethics committees, clinical study teams, and investigational sites
- Review of the safety parts of clinical documents
- Training (PV, Eudravigilance)
- Inspections, audits, CAPA
- Literature search, review, and identification of AEs
- Mentoring of trainees and junior DSOs
- Scientific publication writing
- Microsoft office, Safety Easy, Eudravigilance (EVWEB, EVVET), MedDRA browser, eCRF, IVWRS, Pubmed
- Languages: French (mother tongue), English (fluent)

Mes compétences :
Épidémiologie
Pharmacovigilance
Microbiologie
Pharmacien
Recherche documentaire
Recherche scientifique
Office
Outlook
Sécurité
Oncologie
Formation
Rédaction
Régulation
Essais cliniques

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

Réseau