Durham
• I am trained both in Epidemiology (MPH, PhD) and in pharmacy (PharmD) with 7 years of experience in the field of Epidemiology both at the French national agency of research (INSERM) and in CROs.
• Actively involved for 7 years in the conduct of multinational observational studies for numerous Pharma companies, I bring my expertise for the largest worldwide leading CRO in the study proposal development process, I support bid defence meetings, design protocols, CRF and execute/oversee the analysis and the report of observational programs, including:
- Patient, Disease, Pregnancy, Product Registries;
- eHCD (claims, EMR)
- Safety (PASS), Benefit/Risk assessment;
- Comparative Effectiveness studies;
- Market Access/Expanded Labeling;
- Quality of Life/Patient Reported Outcomes studies.
• Active member of the ENCePP, EMA expert, I am knowledgeable about the new EU PV legislation and the GVP modules (in particular VII, VIII and XVI) and I have a good track record of successfully designed PASS/DUS approved by the PRAC since july 2012.
• Author of numerous publications in intl. peer reviewed journals (including International and American Journal of Epidemiology & Pharmacoepidemiology and Drug Safety)
• I have built strong communication, commercial and team-work skills
Specialties: Pharmaceutics, Epidemiology, Pharmaco-epidemiology, Risk management, Late phase, post-marketing studies, PhD, Cancer, Public Health, cohort studies, case control, surveys,
Mes compétences :
Statistics
Epidemiology
Cancer research
Pharmacy
Public health
Risk management
Pharmacovigilance
Consultancy
