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Nicolas MARTIN

BOULOGNE-BILLANCOURT

Electionseuropéennes 2024

RETROUVEZ GRATUITEMENTLe résultat des européennes à Boulogne-Billancourt ainsi que le résultat des européennes dans les Hauts-de-Seine.

En résumé

I am an Associate Director with more than 7 years’ experience in pharmacovigilance pre- and post-authorization (incl. compassionate use/named patient programs).

I am acting as a project manager on several pharmacovigilance pre-authorization projects (from phase 1 to 3 worldwide clinical trials) and post-authorization projects (both for European centralized and national approved products) to set-up and maintain pharmacovigilance systems, in line with applicable regulations. I am also acting as Deputy EU QPPV.

Working in a consulting company gave me the opportunity to develop an extensive experience in terms of type of products, indications and geographical areas.

I am also involved in “pre-project” activities, including contact with prospects to understand their needs, pharmacovigilance proposals writing and follow-up, pharmacovigilance agreements preparation.

Finally, I’m coordinating some quality assurance activities, in cooperation with the quality assurance department, such as organising the preparation, review, update, publication of relevant procedures, review and follow non-conformities or CAPA plan on a regular basis, prepare audit or inspections.

Key skills:
• Set-up of pharmacovigilance systems (incl. interactions with all stakeholders and set-up of partnerships)
• Management/coordination of pharmacovigilance projects as project manager (leading a project team)
• Case management
• Pharmacovigilance deliverables writing and submission (DSUR, PSUR, PSMF, SMP…)
• Vigilance safety database administration/set-up/maintenance
• EudraVigilance system (company/users registration, case reporting via EVWEB and product registration in the XEVMPD)
• Standard Operating Procedures writing and maintenance
• Internal/external staff training
• Good communication/interactions skills

Mes compétences :
Essais cliniques
Gestion de projet
Pharmacovigilance
Affaires réglementaires
XEVMPD
EudraVigilance
BPC/GCP
BPV/GVP

Entreprises

  • Voisin Consulting Life Sciences - Associate Director, Pharmacovigilance

    2016 - maintenant

  • Voisin Consulting Life Sciences - Senior Pharmacovigilance Scientist

    2011 - maintenant As Senior Pharmacovigilance Scientist, I am responsible for:

    Operational aspects:
    • Acting as Responsible Person for EudraVigilance and EU Deputy QPPV on relevant projects
    • Setting-up of Pharmacovigilance systems for Marketing Authorization Applicant/Holders and clinical trial Sponsors
    • Safety cases management / Expedited reporting / Reconciliation
    • Quality control of work of other staff members
    • EudraVigilance System: company/users registration, product registration in XEVMPD, ICSRs reporting (EVWEB Trader/EVPOST)
    • Safety Vigilance database validation/administration/set-up/maintenance
    • Pharmacovigilance deliverables writing/review (Safety Management Plan, DSUR, PSUR, PSMF/PSMF summary, RMP, IDMC/DSMB charter…)
    • Pharmacovigilance technical and regulatory advice to Client
    • Contact with Regulatory Authorities

    Organizational aspects:
    • Maintaining current knowledge of global safety and vigilance regulations
    • Supervision of the development and management of appropriate tracking tools for designated projects
    • Pharmacovigilance Standard Operating Procedure writing/updating/review
    • Trainings of internal and external staff
    • Set-up of partnerships
    • Vigilance internal Topic Group participation

    Business development and “pre-project” activities:
    • Contact/discussion with prospects
    • Pharmacovigilance proposals writing and follow-up with client
    • Pharmacovigilance agreements preparation

    Line Management activities (1 line managee):
    • Define managee objectives, monitor performance throughout the year, conduct yearly appraisal
    • Organize and plan activities for managee
    • Define managee training needs

  • Voisin Consulting Life Sciences - Pharmacovigilance/Regulatory Scientist

    2009 - 2011 As Pharmacovigilance Scientist, I was responsible for:

    Operational aspects:
    • Safety cases management (data entry, narrative writing, queries generation) / Expedited reporting
    • Quality control of work of other staff members
    • EudraVigilance System: company/users registration, product registration in XEVMPD, ICSRs reporting (EVWEB Trader/EVPOST)
    • Safety Vigilance database validation/administration/set-up/maintenance
    • Pharmacovigilance deliverables writing (Pharmacovigilance Procedure, Annual Safety Report …)
    • Contact with Regulatory Authorities
    • Preparation, submission and regulatory maintenance of Clinical Trial Applications in Europe
    • Maintenance of Clinical Trial Applications requirements in Europe, associated with country specific requirements

    Organizational
    • Maintaining current knowledge of global safety and vigilance regulations
    • Development and management of appropriate tracking tools for designated projects
    • Vigilance internal Topic Group participation
    • Pharmacovigilance Standard Operating Procedure updating

    “Pre-project” activities:
    • Pharmacovigilance proposals writing

  • Voisin Consulting Life Sciences - Regulatory Scientist Trainee

    2009 - 2009

  • University of Toronto - Research Assistant - Pharmacology and Toxicology Department

    2008 - 2009 Dr Susan George’s team – Molecular Pharmacology of brain’s neurotransmitters
    • Study of pharmacological properties of hetero-oligomer μ et δ opioid receptors
    • Publication of a research paper in the British Journal of Pharmacology: “Agonist at the δ-opioid receptor modify the binding of µ-receptor agonists to the µ-δ receptor hetero-oligomer”

  • IPMC - Institut de Pharmacologie Moléculaire et Cellulaire - Research Assistant

    2007 - 2007 Dr Jean-Louis Nahon’s team – Genomics and Evolution in Neuro-Endocrinology
    • Study of regulatory sequences of the promotor of the gene of receptor MCH-R2

Formations

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