Laboratoire Lilly France
- Pharmacien chargé de pharmacovigilance (SNC et Oncologie)
2004 - maintenantSince September 2004- LILLY France Laboratory –Safety case manager (CNS and oncology)
• Management of adverse events cases reported spontaneously or associated with clinical trials: data collection, MedDRA coding, case assessment, evaluates the expectedness, define French imputability scoring and writing narratives.
• Reportability: validate expedited reports from the international data base for submission, in time, to local regulatory agency AFssaps in order to meet regulatory requirements.
• Work on French intensive monitoring of marketed products according to the risk management plan requirements.
• Take part in elaboration of answers to health care professional on product safety, writ pharmacovigilance processes and policies and provide answers by phone, after a risk/benefit evaluation to health care professionals.
• Writing French cases PSURs synthesis for internal-use and perform assessements on the Marketed product's French intensive monitoring.
• Work in collaboration with clinical research team or CRO on clinical trials adverse event’s management, provide a support to improve and control the quality of their safety reports and train them to pharmacovigilance follow-up conduction in clinical trials
. Work with the French AQC on French affiliate quality assurance, audits and inspections readiness.
Laboratoire Lilly France
- Stage en assurance qualité et management des PSURs
2003 - 2004 September 2003–July 2004– LILLY France Laboratory-Trainee in quality assurance and PSUR management: Within the framework of the master’s degree in: quality assurance
• Prepare pharmacovigilance department to any authority’s inspection by creating a data base for drugs regulatory status and a schedule for PSURs submission.
• Take part in internal audit readiness with quality assurance team.
Centre de recherche et developpement SAIDAL
- Pharmacien au département galénique
2002 - 2003 October 2002 – June. 2003 – SAIDAL laboratory -Research and Development Center for generic drugs- in Algeria.
Galenic development and transposition of liquid generic drugs to industrial scale and prepare the galenic department to audit for ISO 9001 certification.
