CONSULTANCY :

– Clinical trials and post-Marketing Pharmacovigilance processes management with the concerned company departments (multidisciplinary and transversal work).

– Putting in line your Vigilance Units with the relevant  and applicable Health Product Regulation in force.

– Providing support for preparation, participation, and follow-up of Pharmacovigilance Audits and French GMP Inspections.

– Providing support for preparation, participation, and follow-up of CE-marking Audits (Materiovigilance matters).

WRITING / VALIDATION OF DOCUMENTS :

– Mandatory Regulatory safety reports or any documents requiring scientific or medical assessment (signal detection, good use of medicines).

– Initial and reminders of Vigilance Trainings or of drug-induced organ toxicity.

SHORT-LIVED REPLACEMENT PERIODS :

– As EU-Qualified Person for Pharmacovigilance or deputy to EU-QPPV.