Mes compétences :
Pharmacovigilance
Audit
International
Entreprises
Management Sciences for Health
- Pharmacovigilance Consultant
Casablanca2010 - 2011- National Assessment of the Medicine Safety Systems of South African Pharmaceutical Companies and Sponsor's with the IPAT (indicator-based Pharmacovigilance Assessment Tool): Provide support for the SPS national assessment project by facilitating and conducting assessments of the pharmaceutical industry component using the IPAT tool developed.
- Strengthen regulatory PV in the area of capacity building and monitoring AE in clinical trial: Assist SPS activities in the development of drug safety and assessment system for clinical AE for the MRA.
- Support the Clinical Trial regulation in South Africa: Support SPS activities in the development of the clinical trial.
Independant
- Drug Safety & Vigilance Consultant
2010 - maintenantDRUGS & MEDICAL DEVICES:
- Set-up of compliant Vigilance systems
- Regulatory Vigilance
- Good PharmacoVigilance Practices: Preparation of customized clinical drug safety and PharmacoVigilance Standard Operating Procedures (SOPs)
- Training (university & professionals)
- Drug/Med Devices safety database management
- Expedited Reporting
- Assistance in MAA: Support in Preparation PharmacoVigilance plan & PharmacoVigilance system description
- Knowledge management
- Project Management
Voisin Consulting
- Vigilance Professional
2007 - 2008RESPONSABILITIES
==> Project & team management
==> PharmacoVigilance training
==> Client’s main contact point
==> Regulatory Competent Authority’s main contact point
==> Management of relation with Investigator and CRA
==> Management of relation with QPPV and Safety Officer
MISSIONS
o Expedited reporting:
- Narrative case preparation
- Adverse Reactions reporting to Ethics Committees and National Competent Authorities
- ICSR electronic reporting by Eudravigilance
- Eudravigilance medical product dictionary registration
o Periodic safety reporting:
- ASR preparation in collaboration with Investigators
- PSUR preparation in collaboration with QPPV
o Assistance in MAA:
- Preparation of MAA Module 1.8.1 - PharmacoVigilance System Description
==> Results: Submission in the 27 European countries
o Good PharmacoVigilance Practices:
- Preparation of customized clinical drug safety and PharmacoVigilance Standard Operating Procedures (SOPs) for clients or for internal activity
- Process know-how
==> Results: Successful audit
o Drug safety database management:
- PharmacoVigilance module in Safety-Easy database (PharmacoVigilance database system ICH-E2B compliant)
- Vigilance module in Safety-Easy database (Vigilance database system)
==> Results: Good management of the cases
o Knowledge management, as Leader of the Vigilance task force:
- Internal training in PharmacoVigilance
- Information day at EMEA on signal detection (June 2008)
- Comments on Note for Guidance Eudravigilance Human Version 7.1 to Eudravigilance
==> Results: Efficient sharing knowledge at Voisin Consulting
Voisin Consulting
- Regulatory Affairs Consultant
2007 - 2008RESPONSABILITIES
==> Team Leader
==> Client’s contact point
==> Regulatory Competent Authority’s contact point
==> Management of relation with Investigator and CRA
MISSIONS
o Clinical trial handling:
- CTA preparation and initial submission
- First patient inclusion
- Amendments
o Good Clinical Practices :
- Standard Operating Procedures (SOP) writing
==> Results: Submission and approbation of 10 studies in 12 European countries
o ATU (Autorisation Temporaire d'Utilisation) Handling:
- ATU dossier preparation and submission
- Patient Inclusion monitoring
- Preparation Training
==> Results: Submission and approbation of 1 program in 1 country
