Toxicology Chimical Safety Officer
On site
Brabant, Belgium
Full Time
27-01-2025
Job Specifications
Toxicology Chemical Safety Officer
Contracting – Walloon Brabant
The Responsibilities
Writing and monitoring risk assessments for impurities (eg, justification of specifications, elemental impurities risk assessments, extractables and leachables, degradation products, ICH M7-compliant evaluations, etc.)
Planning, coordinating and monitoring the conduct of toxicology studies at contract research organizations in line with project timelines and budget
Performing and monitoring toxicological risk assessments for various health-based exposure limits (PDEs, ADIs, etc.)
Performing and monitoring environmental risk assessments (ERAs) and oversee the conduction of environmental studies to support such assessments.
Authoring and/or reviewing reports, protocols, guidelines, guidances and SOPs and ensuring harmonized approaches with regard to the toxicological assessments
Representing the non-clinical safety team in cross-functional meetings
Providing support in the construction of CMC regulatory documents and positional papers (i.e., IND/NDA documents, MAA, etc.)
Providing support to HS&E in the interpretation of toxicological study data produced in the context of REACH or CLP regulations
Maintaining traceability of the assessments performed and the reports produced
Maintaining adequate knowledge in the chemical and environmental field through conference attendance, training and benchmarking
Skills and Knowledge Requirements
Good knowledge about non-clinical safety evaluation of starting materials, synthesis intermediates and impurities, degradation products, leachables and extractables and associated guidelines.
Leadership skills: problem solving, diplomacy
Professionalism skills: reliability and integrity
Organizational skills: multi-tasking, prioritizing
Team building skill: collaboration, communication, respect
Analytical skills: reporting, critical thinking
Our Offer
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
About the Company
Jefferson Wells offers organizations the expertise they need to fuel business growth. Our mission is to attract, assess and match professionals with in-demand skills to careers within Engineering and Life Sciences. Jefferson Wells is part of the ManpowerGroup family of brands. To learn more, visit our website. Know more
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