Toxicology Chemical Safety Officer
Contracting – Wallon – 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.
