Melissa LONGHURST

En résumé

Entreprises

• HRA-PHARMA - Assitante Pharmacovigilance

  2013 - maintenant

• Laboratoire CEPHALON - Assistante de Direction, Pharmacovigilance Europe

  2007 - 2013 • Provide full administrative support to the Vice-President EEA QP PV and department (6 persons).
  • Permanent contact with Headquarters in U.S.A and European affiliates.
  • Administrative tasks: on-line calendars, travel arrangements, department budget, expense reports invoices and purchase orders
  • Coordination and set up of conference calls, meetings, special events and meeting minutes
  • Written correspondence (WW Health Authorities, Ethics Committees, Investigators, Eudravigilance)
  • Provide support on Pharmacovigilance Agreements
  • Support in providing documents for the preparation of CIOMS I, PSURs, Clinical Trial Line-Listings, presentations, Risk Management Plans
  • Support and involvement in Afssaps and MHRA inspections (documentation, scribe, translator)
  • Support to the DSOs in preparation, processing and case submissions (E2B & paper) to the regulatory authorities in the respective countries of responsibility as required in a timely manner
  • EVMPD data entry in Register™ (ArisG) database, project in liaison with Regulatory Affairs Europe
  

• Laboratoires FOURNIER - Assistante

  1992 - 2007 Over 16 years of experience within Laboratoires Fournier Pharma providing support to Senior Management and teams in the following departments:
  Global Pharmaceutical Development, Regulatory Affairs, Clinical Research , Quality Assurance

Formations

Réseau

• __ CERCLE ASSIST'PRO

• Christelle PERROT

• Robin CHAMOROT