Non-clinical Drug Safety Study Monitor

il y a 2 semaines


BoulogneBillancourt, Île-de-France Ipsen Innovation (SAS) Temps plein

Summary / purpose of the position

  • Schedule, Design, Supervise, and Review toxicology and safety pharmacology invitro and invivo studies
  • Ensure that toxicology dossiers of Ipsen products are designed and conducted in compliance with international regulatory requirements and internal Ipsen procedures for clinical evaluation and regulatory registration
  • Create and update NCDS Function plans for all the projects
  • Responsible for delivery of documents (study reports and regulatory summaries) in the Ipsen document management system
  • Responsible for the quality and adequacy for the tabular and written toxicology and safety pharmacology summaries for submissions

Main responsibilities / job expectations

Monitor in-vitro and in-vivo non-GLP and GLP safety pharmacology and toxicology studies (from Lead selection to registration)

  • Participate to the selection of appropriate CROs for a given study
  • Schedule and design the study protocols, ensure appropriate initiation of the study and adequacy of the protocol with the project needs, under the supervision of the NCDS project manager
  • Supervise critical phases of the study, including regular onsite visit at CROs
  • Review online study data to ensure appropriate adaptation of the study protocol
  • Review content of the different draft reports, liaise with the NCDS project manager to deliver a final draft for approval by NCDS management

Support NCDS regulatory documentation

  • Responsible for the quality and adequacy of the tabular and written toxicology summaries for submission (review of TSR received from the CRO, update or review of regulatory documents (IB, IND, Briefing documents)
  • Responsible for delivery of RFS documents (study reports and regulatory summaries) in the Ipsen document management system
  • Responsible for ensuring study data compliant and for loading in the Ipsen data base
  • Responsible for ensuring that the SEND data format request is contracted to service providers, communication with Non Clinical Data Manager to ensure good quality of SEND data and that deadlines are respected.
  • Support for project managers according to the problematic encountered (bibliographical research, Review/QC of documents )

Manage Outsourcing

  • Set up a process for search, evaluation, and selection of contract organization (CRO) to support NCDS activities
  • Maintain and update a database including CRO features

Be the LRM (Local Resources Manager) for NCDS

  • Create and update NCDS Function plans for all the projects
(Creation/update of dates, cost, FTE per task for studies, support to regulatory activities, support to program/project)

  • Discussions with NCDS Project Managers and regular meetings with DMPK to align the DMPK and NCDS plans

EHS responsibilities:

  • Comply with applicable EHS regulations and procedures.
  • Participate in the site's EHS performance by reporting risks, malfunctions or improvements
  • Participate in mandatory EHS training

Experience / Qualifications
Experience / Qualifications

Educational level in Toxicology. Experience within CRO is highly recommended.

Key Technical Competencies Required

  • Key Required Technical Competencies:
Sense of organization and priorities

Ability to work in a team with a multidisciplinary environment

Ability to communicate, anticipate and coordinate (management of CROs)

#LI-Hybrid
LI-MC1
  • clinical safety officer

    il y a 2 semaines


    Boulogne-Billancourt, Île-de-France ALIOS Conseil Temps plein

    Job Description: Participate in the development of documents covering Safety aspects in clinical studies/investigations such as: investigator brochure, protocol, safety plan, statistical analysis plan, etc. Analyze the effects and adverse events of pharmaceutical products and medical devices, identify potential cases of PV/MV and ensure their reporting in...


  • Boulogne-Billancourt, Île-de-France Ipsen Bioscience, Inc. Temps plein

    We are looking for a Medical Director in the Rare Diseases Therapeutic Area to join our Clinical Development team. The Medical Development Director will provide medical guidance and leadership in the design, implementation, monitoring and interpretation of our clinical development programs in rare liver diseases.Main responsibilities / job expectationsMain...

  • Safety Specialist

    il y a 1 semaine


    Boulogne-Billancourt, Île-de-France Excelya Temps plein

    Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care. We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 900 Excelyates. Our unique one-stop provider service model – leveraging full-service,...

  • Safety Specialist

    Il y a 2 mois


    Boulogne-Billancourt, Hauts-de-Seine, France Excelya Temps plein

    Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 900 Excelyates. Our unique one-stop provider service model – leveraging full-service,...


  • Boulogne-Billancourt, Île-de-France STERIMED Infection Control Temps plein

    THE STERIMED GROUP With 1, employees and 12 factories on 3 continents, STERIMED is the world's leading manufacturer of materials and packaging systems based on renewable resources for the sterilization of medical devices, a market experiencing strong structural growth and an absolute requirement for quality and safety. Sterimed develops, produces,...

  • Product Owner

    il y a 2 semaines


    Boulogne-Billancourt, Île-de-France Netatmo Temps plein

    Company Description What we do?**We develop groundbreaking, intuitive and beautifully-designed connected consumer electronics. Truly smart, our innovative products provide a seamless experience that helps users create a safer, healthier and more comfortable & eco-friendly home.We also collaborate with strategic partners to revolutionize your home : Velux...


  • Boulogne-Billancourt, Île-de-France COMEXPOSIUM Temps plein

    **Qui sommes nous ?**Study Advisor fait partie de l'Etudiant. Le groupe Etudiant c'est une équipe de 150 personnes en France au service de l'orientation des jeunes de 15 à 25 ans **Le poste**:En charge de la stratégie de vente de votre périmètre, vous serez garant de son chiffre d'affaires et de sa marge commerciale. Vos missions sont l'encadrement...

  • Regional Site Manager France

    il y a 1 semaine


    Boulogne-Billancourt, Île-de-France Phoenix Tower International Temps plein

    JOB TITLE:Regional Site ManagerREPORTS TO:Operations ManagerDIRECT REPORTS: 0LOCATION: Paris, FrancePURPOSE:Responsible for managing site level operations for a portfolio of wireless infrastructure assets, comprising of towers, rooftops and DAS networks. Responsibilities include the integration of new assets, maintenance of the assigned portfolio of sites...


  • Boulogne-Billancourt, Île-de-France Michelin Oy Temps plein

    Watèa - Responsable des Partenariats Finance et Assurance page is loaded Watèa - Responsable des Partenariats Finance et Assurance Apply locations Boulogne Billancourt posted on Posted 2 Days Ago job requisition id R Watèa - Responsable des Partenariats Finance et Assurance Qu'est-ce que Watèa ?Filiale du Groupe Michelin et du Crédit Agricole Leasing &...


  • Boulogne-Billancourt, Île-de-France Arabelle Solutions Temps plein

    EntrepriseArabelle Solutions propose un large portefeuille de technologies et des services de îlots de turbines qui sont utilisés dans plus d'un tiers des centrales nucléaires dans le monde, aidant ainsi les clients du monde entier à fournir une énergie fiable dans leur transition vers un avenir à faibles émissions de carbone. La turbine à vapeur...

  • Machine Learning Engineer

    il y a 1 semaine


    Boulogne-Billancourt, Île-de-France MWM Temps plein

    MEETING MWMFounded in 2012 by Jean-Baptiste Hironde, MWM is a global leader in developing and publishing mobile applications in creative domains, with over 600 million downloads worldwide. Recognized as the top French app publisher, we are known for our innovative approach and a touch of 'madness' that inspires unconventional thinking.Headquartered in...


  • Boulogne-Billancourt, France Ipsen Innovation (SAS) Temps plein

    **Summary / purpose of the position** - Schedule, Design, Supervise, and Review toxicology and safety pharmacology in-vitro and in-vivo studies - Ensure that toxicology dossiers of Ipsen products are designed and conducted in compliance with international regulatory requirements and internal Ipsen procedures for clinical evaluation and regulatory...


  • Boulogne-Billancourt, France Excelya Temps plein

    Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care. We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model - leveraging full-service,...

  • Clinical Study Manager Hf

    il y a 7 jours


    Boulogne-Billancourt, France Kelly Temps plein

    **KELLY OCG**, est une société de prestation de services intellectuels dédiée aux industries de santé. Notre savoir-faire, le domaine des **Life Sciences**. Notre client est un laboratoire pharmaceutique international, qui s’engage pour le progrès thérapeutique au bénéfice des patients, en lien avec les professionnels de santé. Sa croissance...


  • Boulogne-Billancourt, France Ipsen Bioscience, Inc. Temps plein

    We are looking for a Medical Director in the Rare Diseases Therapeutic Area to join our Clinical Development team. The Medical Development Director will provide medical guidance and leadership in the design, implementation, monitoring and interpretation of our clinical development programs in rare liver diseases. **Main responsibilities / job...


  • Boulogne-Billancourt, France Excelya Temps plein

    Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care. We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model - leveraging full-service,...

  • Clinical Trial Associate

    Il y a 2 mois


    Boulogne-Billancourt, France IPSEN Temps plein

    **Title**: Clinical Trial Associate (CTA) H/F **Company**: Ipsen Pharma (SAS) To assist in the delivery of Clinical Development objectives and achieve Clinical Operation Excellence, mainly by supporting the Clinical Research Manager (CRM)/Clinical Project Manager (CPM) in administrative activities within the conduct of the clinical studies. To also...

  • Safety Specialist

    Il y a 2 mois


    Boulogne-Billancourt, France Excelya Temps plein

    Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 900 Excelyates. Our unique one-stop provider service model – leveraging full-service,...

  • Safety Specialist

    il y a 4 semaines


    Boulogne-Billancourt, France Excelya Temps plein

    Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 900 Excelyates. Our unique one-stop provider service model – leveraging full-service,...


  • Boulogne-Billancourt, France Ipsen Pharma (SAS) Temps plein

    **Purpose of the position** The Clinical Partnerships Oversight Manager is responsible for supporting the management of Ipsen’s relationships with it’s Service Providers (CROs) within Clinical Development. They are a critical player in the Service Provider Governance and Escalation structure, working to support the Clinical Partnerships Oversight...


  • Boulogne-Billancourt, France IPSEN Temps plein

    **Title**: SVP, Head of Global Patient Safety **Company**: Ipsen Pharma (SAS) - The Senior Vice President, Global Patient Safety is accountable to define the overall Patient Safety strategy for Ipsen across the portfolio (Oncology, Neurosciences, Rare Diseases) from Discovery to development and post marketing approvals’ maintenance, in order to meet...

  • Medical Writting Associate F/m

    il y a 2 semaines


    Boulogne-Billancourt, France Ipsen Pharma (SAS) Temps plein

    **Main responsibilities / job expectations** **Main Medical Writing responsibilities** - Manages the preparation of regulatory documents e.g. CSRs, briefing documents, meeting requests, Clinical modules. - Leads Writing/Editing complex Clinical Dossiers/Safety Reports - Reviews documents to ensure compliance with documentation quality standards and...


  • Boulogne-Billancourt, France Ipsen Pharma (SAS) Temps plein

    Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients’ health and quality of life and providing them with effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in...


  • Boulogne-Billancourt, France IPSEN Temps plein

    **Title**: IT Business Analyst Clinical **Company**: Ipsen Pharma (SAS) The role of IT Clinical Development Domain (CDO) and will be empowered to - Leads the analysis of business problems and the translation of business requirements into successful technical solutions and processes to meet business needs. - Analyze business partner’s operations to...

  • IT Business Analyst Clinical

    il y a 21 heures


    Boulogne-Billancourt, France IPSEN Temps plein

    **Title**: IT Business Analyst Clinical **Company**: Ipsen Pharma (SAS) The role of IT Clinical Development Domain (CDO) and will be empowered to - Leads the analysis of business problems and the translation of business requirements into successful technical solutions and processes to meet business needs. - Analyze business partner’s operations to...

  • Medical Writer

    Il y a 2 mois


    Boulogne-Billancourt, France AIXIAL Group Temps plein

    Descriptif du poste Nous sommes actuellement à la recherche d’un **Medical Writer H/F** dont les missions principales seront les suivantes (liste non-exhaustive): - Rechercher des informations auprès des interlocuteurs techniques (rédacteurs médicaux, médecins, statisticiens, équipiers des affaires réglementaires et de pharmacovigilance) -...

  • Medical Writer

    il y a 2 jours


    Boulogne-Billancourt, France AIXIAL Group Temps plein

    Descriptif du poste Nous sommes actuellement à la recherche d’un **Medical Writer H/F** dont les missions principales seront les suivantes (liste non-exhaustive): - Rechercher des informations auprès des interlocuteurs techniques (rédacteurs médicaux, médecins, statisticiens, équipiers des affaires réglementaires et de pharmacovigilance) -...


  • Boulogne-Billancourt, France Ipsen Bioscience, Inc. Temps plein

    As Director/Sr Director, External Innovation - Oncology, you will play a leadership role in IPSEN’s External Innovation group, spearheading efforts to identify, evaluate, and secure Oncology external opportunities (pre-clinical and clinical stage as well as marketed therapeutic assets). It is expected that these efforts will provide direct and visible...

  • Work-study program

    Il y a 2 mois


    Boulogne-Billancourt, France STERIMED Infection Control Temps plein

    With 1, employees and 13 factories on 3 continents, STERIMED is the world's leading manufacturer of materials and packaging systems based on renewable resources for the sterilization of medical devices, a market experiencing strong structural growth and absolute requirements in terms of quality and safety. Sterimed develops, manufactures, transforms, and...

  • Work-study program

    il y a 4 semaines


    Boulogne-Billancourt, France STERIMED Infection Control Temps plein

    With 1, employees and 13 factories on 3 continents, STERIMED is the world's leading manufacturer of materials and packaging systems based on renewable resources for the sterilization of medical devices, a market experiencing strong structural growth and absolute requirements in terms of quality and safety. Sterimed develops, manufactures, transforms, and...

  • Office Manager

    il y a 1 mois


    Boulogne-Billancourt, France Novocure Temps plein

    Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Novocure’s commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma and in the U.S. for the...