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GMDP-0008

Pharmacovigilance Consultant

Disponible
31
Années d'expérience
Pharmacovigilance
Spécialisation
France
Localisation
À propos de cet expert

Pharmacovigilance consultant with 30+ years in pharma. Expert in PV system setup, PSMF, signal detection, PSUR/PBRER writing, QPPV roles, regulatory compliance, team management, and audit readiness. I can provide companies with advices to organise their PV system, to be compliant with EU and international regulations. I can also quickly replace your PV staff in various functions and play the role of EU QPPV or Head of Safety.

Compétences

Expert
SOP Writing & Review Pharmacovigilance
Intermédiaire
CAPA Management Regulatory Submissions Change Control Deviation Management

Certifications

Global Pharmacovigilance System Master File Safety Agreements Benefit Risk Assessment in Pharmacovigilance Pharmacovigilance and Pharmacoepidemiology Certificate University Diploma in Statistics
Demander des informations

Intéressé par cet expert ? Remplissez le formulaire ci-dessous pour démarrer le processus. For €50, you'll receive a detailed anonymized CV. If you'd like to proceed to a personal introduction, that's €1000.