Catherine Gaucher
Global Pharmacovigilance System and Project Lead @Pharmascience
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WORK HISTORY
Global Pharmacovigilance System and Project Lead @Pharmascience
Montreal, QC, CA
Ensured compliance of the PV System with Canadian, EU, FDA and other international Health Authority regulation and GVPs. Ensured quality and performance of the PV System: training, procedural documents writing, deviations, CAPAs, KPIs, evaluation and maintenance of compliance, audits and inspections. Developed and maintained the PSMF. Communication with local QPPVs and international partners in Arab Countries and EU.Negotiated Service Agreements and Safety Data Exchange Agreements.Selection of audit vendors and oversight of external audit activities.Ensured validation and upgrade activities of the Safety Database. Implementation of E2B electronic transmission. Supported Case Processing Team with safety database/case reporting issues.Internalised European Pharmascience PV activities previously outsourced: complete update of the current PV System to incorporate EU specific PV requirements and ensure compliance - Great team accomplishment in a limited period of 12 months.
EDUCATION
UQAM | Université du Québec à Montréal
PhD, Biology
Université de Montréal
DESS - Diplôme d'études supérieures en développement du médicament, Drug Development
UQAM | Université du Québec à Montréal
Master's degree, Biology
SKILLS
ABOUT CATHERINE GAUCHER
A results-oriented bilingual professional with 15 years of experience in the pharmaceutical industry, covering all aspects of pharmacovigilance and with a proven expertise in scientific safety. Very motivated in delivering the highest quality analysis while being able to maintain strong operational skills and leadership in projects.
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