Mes compétences :
CTD
Patent
Pharmacovigilance
Pharmacy
Regulatory Affairs
Entreprises
Stallergenes
- Safety compliance officer
ANTONY2013 - maintenant- ensuring compliance of global pharmacovigilance activities
- Management of the PSMF
- writing and updating pharmacovigilance SOPs
- supporting affiliates to build local PV quality systems
- performing PV regulatory surveillance
- performing quality control of ICSRs, PSURs, DSURs and RMPs
Only For Children Pharmaceuticals
- Regulatory Affairs Trainee
2011 - 2011- Contributed to regulatory strategic decisions
- Attended Project follow-up meetings for a CTD submission via centralised procedure
- Participated to the drafting of a SmPC, a patient leaflet, a labelling and a questionnaire for readability test
- Participated to the drafting of an Application form for a CTD submission to the EMA
- Attended meetings with the EMA regarding regulatory strategy for an orphan medicine and drafted the minutes
- Was in charge of the update of the CTD preparation planning
- Was in charge of a substantial amendment of a CTA to the French Ethics Committee
- Took part in an investigational site initiation visit
- Participated to English to French translation of clinical documents for French nurses
- Organized meetings with European partners
- Wrote meeting minutes
- Created a meeting minutes template
