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Magalie PEREZ BATIGNE

RUY

En résumé

• Experienced French pharmacist. Compliance Manager for European countries, Regulatory Manager for France, nominated pharmacovigilance contact in France. Skills in regulatory affairs, medical affairs, compliance and quality assurance.
• Dynamic, persuasive, strong planning and organizing skills. Proven experience of leadership of a team in a regulated environment, excellent interpersonal skills, ability to function in a rapidly changing environment and able to balance multiple priorities simultaneously. Demonstrated knowledge and application of EU and local country specific regulations / guidelines and Quality System implementation.


Mes compétences :
Biotechnologies
Communicative
Dynamique
Organisée
Pharmacie
Rigoureuse
Bonnes Pratiques de Fabrication

Entreprises

  • PX'Therapeutics

    maintenant

  • Jazz Pharmaceuticals - Pharmacien responsable

    2017 - maintenant Pharmacien Responsable site exploitant
    Responsable qualité et compliance France

  • JAZZ Pharmaceuticals - Pharmacien Responsable Intérimaire, Responsable qualité et compliance

    2016 - 2017 PRI
    Compliance and Quality Manager for Jazz Pharmaceuticals France

  • Fagron Compounding Services - Responsable Qualité

    2015 - 2015 Mise en place d'un système qualité pour un entrepôt de stockage de matière première pou usage pharmaceutique (BPF partie II)
    Projet de développement d'une unite de fabrication de preparations hospitalières.

  • Olympus Biotech - Compliance and Vigilance System Manager

    RUNGIS Cedex 2011 - 2014 Compliance and Vigilance System Manager– OLYMPUS BIOTECH – Lyon (69)
    Responsible for the Management of the Olympus Biotech Europe Compliance and Quality System. Support the Olympus Biotech International pharmacovigilance, Vigilance and Medical information service System. Olympus Biotech is the MAH of 2 centralized authorized medicines and is the distributor of medical devices in orthopedics field.

    • Compliance :
    Management of local European regulatory consultant (Italy, Belgium, Spain, Greece and Switzerland)
    Pricing and reimbursement of Drugs in EU, AU and International markets
    Validation of promotional material on medicinal product and medical device in line with European country regulation.
    Management of the ANSM validation for French promotional material on medicinal products.

    • Medical visit in France
    Implementation and maintenance of the HAS certification, medical visit policy for medical visit in France.
    Field assessment and scenario training management with sales representatives.
    Medical visit metrics report to Quality System.
    Management of the list of compulsory documentation.
    Ensure that sales representative are in accordance with the medical visit charter and HAS guideline.

    • Regulatory :
    French qualified person deputy qualification
    Monitoring of French regulation and implementation of any new requirement in Quality System
    Company representative to ANSM
    Site master file design, modification of manufacturing authorizations, regulatory inspection
    Investigational Medicinal Product Dossier elaboration

    • Pharmacovigilance :
    Nominated pharmacovigilance contact in France for medicinal product and medical device AE.
    Design, write and implementation of procedures describing the MAH pharmacovigilance System
    PSMF and RMP production
    Document and process Medicinal product and Medical device product complaint in line with company procedure and national legislation.
    Electronic reporting of ICSRs to EMA.
    • Quality system:
    Assessment and qualification of suppliers and vendors
    GMP, GLP and ISO vendor audit (completion of about twenty audits)
    Management of self inspection audits
    Risk assessment using FMEA and HACCP methods

    • Quality risk management:
    Deviation investigation and follow-up
    CAPA: Monitoring of corrective and preventive actions,
    Monitoring of change control and follow-up of implementation actions
    Participation in Quality Management review

  • PX THERAPEUTICS - Pharmacien assurance qualité/ PRI

    Grenoble 2004 - 2011 • Qualified person deputy, quality assurance pharmacist – PX THERAPEUTICS – Grenoble (38) Experienced qualified person deputy in a French biotechnology firm which manufactures controls and releases recombinant proteins for clinical trials phases I and II

    • Pharmaceutical batch release:
    Certification of Investigational Medicinal Product for clinical use
    Release of batch records of biotechnology product for clinical use in accordance with Quality specifications
    Management and release of raw material for pharmaceutical use.

    • Regulatory :
    French qualified person deputy qualification
    Monitoring of French regulation and implementation of any new requirement in Quality System
    Company representative to ANSM
    Site master file design, modification of manufacturing authorizations, regulatory inspection
    Investigational Medicinal Product Dossier elaboration

    • Pharmaceutical regulations:
    Excellent knowledge of EU-GMP (Eudralex vol4), Good Clinical Practices, 21 CFR part 210-211, EU pharmacopoeia, USP and ISO 9001, 13485 requirements.
    Specific knowledge in biotechnology requirements: ICH Q5, ICH Q6, ICH S6 and guidance for industry.
    Specific knowledge in European country specific requirement for promotional material.

Formations

  • Faculté De Pharmacie (Angers)

    Angers 2002 - 2003 assurance qualité biotechnologies

    Master II

  • Faculté De Pharmacie (Angers)

    Angers 1996 - 2003 pharmacie filière industrie

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