Portrait of Marie Line El Helou, Pharmacovigilance Consultant

Independent Consultant

Marie Line El Helou

Pharmacovigilance Consultant

Marie Line El Helou is a pharmacist with more than 10 years of experience in pharmacovigilance, supporting biotech and pharmaceutical companies in setting up and running safety systems.
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Certifications

  • Doctor of Pharmacy (PharmD), Lebanese American University, Lebanon
  • MSc Pharmacology, Pharmacokinetics and Pharmacogenetics, Paris Sud University, France
  • MedDRA coding training, MSSO

Marie Line El Helou is a pharmacist with more than 10 years of experience in pharmacovigilance. She supports biotech and pharmaceutical companies in setting up safety systems, both during clinical development and after marketing authorisation.

Her work covers safety strategy across the development and post-marketing phases, including signal detection and management. It also includes inverse signal detection to identify unexpected potential therapeutic benefits, PV system setup and optimisation, and audit and inspection readiness. She supports scientific and regulatory writing (RMPs, DSURs, PSURs, PSMF and signal activities) and offers targeted training on local French PV requirements. She works in English, French and Arabic.

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Modern office building facade with large windows featuring vertical panels in shades of orange, yellow, and brown, with autumn-colored trees and tall dry grasses in the foreground.
Spiral staircase in a bright, modern building
Modern office building with large glass windows reflecting its interior, showing orange letters spelling MAFINEX.
Woman with curly hair wearing business attire, leaning on a glass balcony and looking up while holding a smartphone with both hands in a modern building with white structural beams.
Medical team walking along a glass corridor in a hospital
Modern office workstation in a clinical research facility
Two healthcare professionals talking on a glass balcony in a modern hospital
Three healthcare workers in scrubs taking a break and talking in a sunlit hospital hallway with large windows.
Modern office building with large glass windows reflecting its interior, showing orange letters spelling MAFINEX.