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Ghania CHAMOUNI

Saint-Denis

En résumé

Has 17 years experience in Pharmacovigilance (PV) (pre and post-marketing) and Regulatory Affairs (RA) for Drugs, Cosmetics and Medical Devices. Possesses a strategic approach to problem solving, excellent
planning, time management and teamwork skills. Has multi-tasking skills, decision-making and initiative to
take on challenges to meet deadlines as a team player.

Entreprises

  • Ansm - PRAC MEMBER

    Saint-Denis 2017 - maintenant

  • APTALIS PHARMA - Deputy EUQPPV - PHARMCOVIGILANCE MANAGER EUROPE

    2013 - 2017 Manage the European Pharmacovigilance department
    o Represent the company in meetings with EU regulatory authorities (clarification meetings, oral explanations)
    o Perform continuous assessment of products B/R balance
    o Successfully passed FDA, MHRA, ANSM inspections
    o Implement and update the PV System & performance measurements
    o Develop and implement RMP & PASS (and related activities) and SDEA
    o Participate in the working groups and committees (crisis management, signal detection, RMP, KPI..)
    o Review/approve/and maintain PV documents (e.g., PSURs/PBRERs, DSURs, PASS and clinical studies protocols,
    RMP)
    o Oversight PV activities of market researches, patients programs, IIS and clinical studies
    o Ensure product safety information is up‐to‐date and provide input in the safety variation’s preparation
    o Develop gap analysis, working PV documentation and transition plans
    o Provide training on Pharmacovigilance awareness, procedures and regulation

  • Septodont - Regulatory Affairs Manager

    Saint Maur des Fossés Cedex 2013 - 2013 Developed and implemented CTD sections 2, 4 and 5 (Clinical and Preclinical)
    o Coordinated the regulatory activities in relation with PV topics between the internal stakeholders (R&D,
    pharmacovigilance, Quality, Regulatory Affairs)
    o Prepared and implemented CCDS/CCSI
    o Ensured compliance with regulatory and pharmacovigilance requirements (ICH guidelines, EMA, FDA, GVP..)
    o Provided expertise and input on PV related issues (worksharing, signal detection, DHPC, responses to authorities ...)
    o RA’s key contact for projects development (registration regulatory strategy, coordination with R&D, internal and
    external experts)
    o Wrote, reviewed and updated SOPs
    o Regulatory intelligence

  • GlaxoSmithKline Consumer Healthcare - GlaxoSmithKline Consumer Healthcare - France & Export

    Marly-le-Roi 2007 - 2012 “Domestic Pharmacovigilance system coordination and oversight”
    o AE cases management, literature review, signal detection, B/R review
    o PV database set‐up and quality controls coordination
    o SOPs / Guidelines / AE forms / DDL writing
    o Labelling updates preparation
    o PSUR preparation and domestic RMP set‐up
    o Market Research and PASS set‐up and coordination
    o Call centre management and oversight (medical information enquiries, Q&A…).
    o Staff training in safety requirements and SOPs
    o PV quality system management (self‐inspection, quality control, metrics, regulatory reporting ...)
    o Medical information and scientific advice
    o Quality controls
    o Audits and inspections preparation and coordination ( ANSM, FDA.. )
    o Regulatory dossiers management and follow‐up (preparation/registration/variations/renewals)
    o Labelling and promotional material management (medical product information, advertising,..)
    o Quality complaints and crisis management (signal detection, batch recalls. ..)

Formations

Pas de formation renseignée

Réseau

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