Haifa SAHMIME

Regulatory affairs officer at ProductLife Group
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Contact Information
us****@****om
(386) 825-5501
Location
Grenoble, Auvergne-Rhône-Alpes, France, FR
Languages
  • Français Native or bilingual proficiency
  • Anglais Native or bilingual proficiency
  • Arabe Native or bilingual proficiency
  • Allemand Elementary proficiency
  • Finnois Limited working proficiency

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Marion ORSET

Haifa est une personne en qui l’on peut avoir confiance, qui cherche toujours à faire de son mieux et à s’améliorer. Son tempérament et sa gentillesse lui permettent de s’intégrer très facilement dans une équipe.

Philippe BISSAY

Haïfa a passé trois ans dans notre équipe affaires pharmaceutiques, c’est un excellent souvenir pour tous , elle a participé à la montée en professionnalisme de l’équipe. Adulte, Responsable , Sympathique, très Organisée, l’idéal pour une entreprise pharmaceutique et une excellente communication avec l’ensemble des équipes

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Credentials

  • Auditeur interne et fournisseurs Dispositifs médicaux ISO13485
    AFNOR Compétences
    Nov, 2022
    - Nov, 2024
  • laughter yoga leader
    The Laughter Yoga University.Madan Kataria
    Jun, 2019
    - Nov, 2024
  • Pharmacovigilance: role, tasks and responsibilities
    IFIS - Institut de Formation des Industries de Santé
    Apr, 2016
    - Nov, 2024
  • Quality applied to the Pharmacovigilance
    IFIS - Institut de Formation des Industries de Santé
    May, 2015
    - Nov, 2024
  • Civic Prevention and Emergency Level 1
    Université de Caen
    Sep, 2014
    - Nov, 2024

Experience

    • France
    • Pharmaceutical Manufacturing
    • 300 - 400 Employee
    • Regulatory affairs officer
      • Feb 2021 - Present

    • Switzerland
    • Biotechnology Research
    • 700 & Above Employee
    • Regulatory Affairs Specialist
      • Dec 2019 - Apr 2020

      - Management of Roche’s instructions as a Regulatory and local safety officer - Interlocutor with the French Health authority relating to materials and reagent vigilance - Management of the implementation of the new MDR (UE 2017/745) - Management of gap analysis on regulatory processes - Back-up for promotional documents’ validation. - Management of Roche’s instructions as a Regulatory and local safety officer - Interlocutor with the French Health authority relating to materials and reagent vigilance - Management of the implementation of the new MDR (UE 2017/745) - Management of gap analysis on regulatory processes - Back-up for promotional documents’ validation.

    • France
    • Oil and Gas
    • 200 - 300 Employee
    • Chemist & QC officer
      • Sep 2017 - Oct 2018

      In charge of Industrial chemistry management within a team of 3 Nuclear Chemists, my duties were: - Supporting Nuclear Engineers for their test preparation, - Radiation protection surveillance by water sampling and Lab analysis, - PH monitoring for Nuclear Water Systems (ammoniac, hydrazine, sulfuric acid), - In charge of Operation and Commissioning chemistry procedures, - Interface with Supply Chain Dept. for Chemicals and consumable supply. In charge of Industrial chemistry management within a team of 3 Nuclear Chemists, my duties were: - Supporting Nuclear Engineers for their test preparation, - Radiation protection surveillance by water sampling and Lab analysis, - PH monitoring for Nuclear Water Systems (ammoniac, hydrazine, sulfuric acid), - In charge of Operation and Commissioning chemistry procedures, - Interface with Supply Chain Dept. for Chemicals and consumable supply.

    • France
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Pharmacovigilance and medical affairs officer
      • Feb 2014 - Jan 2017

      - Management of pharmacovigilance case reports - Writing PV reports (PSUR, DSUR) - Participate to the implementation of the Quality system in PV department - Management of medical information requests - Local literature screening - Management and R&D of Drug under compassionate use - Procedures issuance - Supporting Regulatory affair team - Management of pharmacovigilance case reports - Writing PV reports (PSUR, DSUR) - Participate to the implementation of the Quality system in PV department - Management of medical information requests - Local literature screening - Management and R&D of Drug under compassionate use - Procedures issuance - Supporting Regulatory affair team

  • Habib S Pharmacy
    • Menzel Temime, Tunisie
    • Staff Pharmacist at Habib S Pharmacy
      • Sep 2012 - Jun 2013

      - Realization of all the tasks carried out within a pharmacy: from the order until the setting up of the medicines/ medical device - Validation and execution of the orders - Management of the narcotics and the psychotropic ones - Control of the system of the social cover by insurance companies and mutual societies - Patient health education and pharmacy advice ... - Realization of all the tasks carried out within a pharmacy: from the order until the setting up of the medicines/ medical device - Validation and execution of the orders - Management of the narcotics and the psychotropic ones - Control of the system of the social cover by insurance companies and mutual societies - Patient health education and pharmacy advice ...

    • Staff Pharmacist
      • Jun 2012 - Aug 2012

    • Medical analysis trainee at the National Blood Transfusion Centre in the Haematology unit
      • Mar 2012 - May 2012

      Participation of all the tasks carried out in this service from the pre-analytical phase to the validation of the results while respecting the quality management manual of the CNTS (ABO grouping and Rhesus-kell phenotyping of patients). Looking for RAI irregular agglutinins, antibody titration for transplant patients... Participation of all the tasks carried out in this service from the pre-analytical phase to the validation of the results while respecting the quality management manual of the CNTS (ABO grouping and Rhesus-kell phenotyping of patients). Looking for RAI irregular agglutinins, antibody titration for transplant patients...

    • Hospital internship at the Main Military Hospital of Tunis
      • Sep 2011 - Feb 2012

      Internal use pharmacy Intensive unit care Internal use pharmacy Intensive unit care

    • Nursing care internship
      • Jun 2010 - Jul 2010

  • Pharmacie Habib SAHMIM
    • Menzel Temime, TUNISIE
    • Staff Pharmacist internship
      • Jul 2008 - Aug 2008

      First obligatory training in a pharmacy First obligatory training in a pharmacy

Education

  • Université de Caen Basse Normandie
    Master 2 Professionnel : Développement Clinique du Médicament, UFR pharmacie Caen, Développement clinique et industriel de médicaments, pharmacovigilances et affaires réglementaires
    2013 - 2014
  • Faculté de pharmacie de MONASTIR
    National Pharmacy Degree, Pharmacie
    2006 - 2013
  • Lycée TAIEB M’HIRI Menzel Temime
    Science Bachelor degree, High honor; average: 16.50/20
    2005 - 2006

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