Marina ATZENHOFFER

En résumé

Entreprises

• Sanofi Pasteur - Coordinator en Pharmacovigilance

  Lyon 2014 - 2014 * Worked as PV Quality and Compliance Officer
  * Managed manufacturing investigations ;
  * Managed product technical complaints (PTC) (establishment of potential link with adverse
  events)
  * Wrote pharmacovigilance part of annual product review (APR) ;
  * Performed quality control of safety reports (PBRER, RMP, SAR...)
  
  * Worked in outsourcing of clinical trial cases ;
  * Wrote working documents for the CRO relative to the case processing in PV database (Oracle
  AERS) for each study
  * Wrote instructions regarding the unblinding processes for each study ;
  * Prepared and presented trainings concerning data entry coding rules and case management
  specificities
  * Wrote contractual documents and prepared invoices ;
  * Performed quality control of PV cases ;
  * Answered to CRO questions concerning codage in database

• VIGIPHARM - Chargée de vigilance sanitaire

  Montpellier 2012 - 2013 * Managed cases of pharmacovigilance in Safety Easy and ARISg PV databases: reception,
  validation, MedDra codage, french imputability, company causality, follow-up telephone calls,
  reporting to health authority.
  * Wrote all sections of periodic safety reports (PSUR, PBRER, AOC, Addendum) ;
  * Medical information: answered to patient or health care professional questions ;
  * Performed literature screening ;
  * Translated PV cases (French to English)
  * Participated to audit and inspections

• Sanofi Pasteur MSD - Internship in Pharmacovigilance

  2012 - 2012 * Entered cases in PV database (ARISg) ;
  * Performed medical review and wrote medical assessment ;
  * Performed follow-up telephone calls

Formations

• Faculté De Pharmacie De Strasbourg

  Strasbourg 2005 - 2012 Pharmacien
  
  avec un Master 2 en pharmacologie - science du médicament

Réseau

• Atlan PATRICK