Non-clinical Drug Safety Study Monitor
il y a 2 semaines
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
- 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:
Ability to work in a team with a multidisciplinary environment
Ability to communicate, anticipate and coordinate (management of CROs)
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