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Mohammed BOULARAS

BRUXELLES

En résumé

Consultant at Aprova
Areas of interest: Drug Safety, Pharmacovigilance, Regulatory Affairs, Data Management, Quality Assurance, Clinical Research

Mes compétences :
Pharmacovigilance
Regulatory Affairs
Animal Healthcare
Quality Assurance
Pharmaceutical Industry

Entreprises

  • GSK via Altran - Registration Manager

    2015 - maintenant Compliance - Alignment to file
    Change Control
    Editorial Changes

  • Alfred E. Tiefenbacher (GmbH & Co. KG) - Local Contact Person for Pharmacovigilance

    2014 - maintenant According to the Circular no. 600 which refers to the application of the new legislation about pharmacovigilance, and particularly the changes in pharmacovigilance, as in the royal decree of 14th December 2006 concerning medicines for human use, by means of the royal decree of 28th May 2013, published in Belgisch Staatsbald/Moniteur belge on the 10th of June 2013, in order to adapt directive 2010/84/EU.
    Local Contact Person for Pharmacovigilance is:

    - linked to the Qualified Person responsible for Pharmacovigilance at the European level (EU QPPV)
    - responsible for carrying out activities in pharmacovigilance in Belgium
    - the contact point between Alfred E. Tiefenbacher (AET) and the Federal Agency for Medicines and Health Products (FAMHP)

  • GlaxoSmithKline - Regulatory Specialist

    Marly-le-Roi 2014 - maintenant 1) Registration Manager for Hepatitis vaccines, in GSK Vaccines Global Regulatory Affairs:
    - Involved in the Company’s regulatory and administrative (including database entry) activities for this products lines, basically in Europe/EMA and outside Europe (covering Emerging countries)
    - Ensure the planning/dispatch/submission/follow-up/approval of data-packages due to Regulatory Authorities:
    •Variations, Commitments, Questions & Answers, PSURs, Risk Management Plans (RMPs), Renewals, etc …
    2) Regulatory Project Manager for Zoster vaccine candidate in GSK Vaccine Global Regulatory Affairs:
    - Support the Regulatory Project team in planning and reporting the monthly meetings
    - Maintain the submission plan (MSProject)
    - Update the Intranet team site
    - Contribute to risk management by maintaining the risk register and the visual performance board
    - Ensure each dossier/data-package submission is planned adequately (creation and update of records in RA Planning Database (OPAL)

  • APROVA - ALTEN - Consultant

    2014 - maintenant PRINCE 2 Certificated : Projects in Controlled Environments, version 2

  • 4CLINICS - Safety Scientist

    2013 - 2013 - Draft Pharmacovigilance (PV) Standard Operating Procedures (SOPs) in compliance with the current PV Regulation
    - Support Data Management Team in Data Entry and Quality Control (QC) of Case Report Forms (CRFs)
    - Give support to Medical Writers

  • UCB - Drug Safety Scientist (via 4CLINICS)

    COLOMBES 2012 - 2013 Mission at UCB Pharma, within the Global Clinical Safety and Pharmacovigilance (GCSP) Department / Medical & Scientific Expertise EU Team:
    - Screening scientific literature to identify new safety signals, case reports of adverse reactions, data relevant for Benefit-Risk assessment and inclusion in aggregated reports
    - Medical review and finalization of PSURs related to Internal Medicine UCB products.
    - Support the responses to Health Authorities questions related to UCB drugs
    - Review of signal detection line listings.
    - Safety signal assessment.
    - Safety assessment of the drug labeling.
    - Contribution with safety expertise to cross-functional discussions/decisions.

  • Bristol-Myers Squibb - Pharmacovigilance associate

    Rueil-Malmaison cedex 2010 - 2012 - Internship report: Risk Management Plan of a new antidiabetic BMS product
    - Handling of Adverse Events and Serious Adverse Event reports (post-marketing, clinical studies and Agency cases) from internal and external (foreign and domestic) sources
    - Enter initial cases data into safety database, coding the Adverse Events (AEs) with MedDRA, complete narrative description of the AEs and report imputability events complying with the French methodology of causality assessment
    - Declare the French and foreign cases to health authorities (AFSSAPS, EMA)
    - Manage the Compassionate Use (Autorisation Temporaire d’Utilisation)
    - Draft safety reports: French Summary Reports (Equivalent to PSURs)
    - Give scientific support of information for healthcare professionals
    - Perform quality review for case entries and monitoring of cases and closing files
    - Review source documents to prepare for inspection or audit
    - Review published medical literature to identify AEs and conduct specific database searches for drug-event information
    - Ensure reconciliation between databases of pharmacovigilance and Medical Information Departments
    - Ensure medical and pharmaceutical on-call
    - Leading meetings of “Medical Surveillance” and participate in clinical team meetings
    - Train BMS staff to pharmacovigilance
    - Collaborate with the Medical Information, Regulatory Affairs, Legal and Marketing Departments.
    - Apply the good practices of pharmacovigilance (BPPV: Bonnes Pratiques de PharmacoVigilance)

  • Vetoquinol - Validations and quality assurance engineer

    Lure cedex 2010 - 2010 - Drafting internal Standard Operating Procedures
    - Qualification of sterilization equipments of the production site while complying with Good Manufacturing Practices
    - Give support to metrology team

  • Faculté de pharmacie Limoges - Etudiant / Stagiaire

    2008 - 2009 - Internship in Pharmacology department; Faculty of Pharmacy of Limoges.
    Theme : Study of the effects of a treatment with candesartan on the formation of pressure sores in mice with type 1 diabetes.
    Complying with Good Laboratory Practices

  • Veterinary area - Assistant Vétérinaire

    2004 - 2008 Several internships of 2 to 3 months (15 months in total)as veterinary assistant.

Formations

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