For the expansion of the nonclinical Pharmacology &Toxicology (PharmTox) team, argenx is looking for a Toxicology risk assessor-data manager based in Gent. The level and title will depend on the experience of the incumbent. The team is a functional expert group within the development department with expertise in nonclinical safety testing, operations of regulated studies and nonclinical and clinical BioAnalytics.
The toxicology risk assessor-data manager will tightly work with the Toxicologists of the team and stakeholders from other functional teams (including CMC, project management, ..). The toxicology risk assessor-data manager will be part of a functional team that discusses scientific matters and solves issues together. We are committed to train and develop team members, enthusiastic beginners are invited to apply. The incumbent will report to a Toxicologist Pharmtox.
The data that are produced and processed within the PharmTox team can be submitted to Health authorities and therefore strict quality control rules apply. A high sense of quality including quality checks (QC) are part of the responsibilities. argenx has an outsource model and the majority of the work is conducted at contract research organizations on behalf of argenx. The coordination of this outsourced work is an important aspect.

Responsibilities include:

• Performs toxicology risk assessments in line with pertaining regulatory guidelines with regards to manufacturing events, product impurities, extractables & leachables and excipients in accordance with argenx procedures. Supports and interacts with manufacturing (CMC), Quality, Regulatory Affairs and other functional areas (such as Medical Affairs and Global Patient Safety- GPS) to facilitate integrated health risk assessments.
• Responsible for literature searches in scope of assigned assessments. Oversees database searches that are commissioned to 3rd parties.
• Responsible for information flow between internal and external stakeholders (e.g. CMC, Toxicology, GPS, regulatory and 3rd party vendors): point of contact for such assessments. Formulates recommendations with respect of likely hazards associated with the use of the substances in humans, for the approval by PharmTox SME.
• Responsible to keep monographs and internal databases of impurities, excipients, residuals, extractables and leachables up to date.
• Responsible to receive, store and manage data of owned studies.
• If applicable, summarize data in table or other formats for inclusion in regulatory dossiers. Support analysis and visualization of nonclinical data.
• Contributes and reviews regulatory documentation with regards to area of expertise.
• Ensure owned documentation complies with quality standards (e.g. compliance with eCTD or other standards necessary for submission to health authorities).
• Interacts with internal stakeholders (e.g. Business Information System, IT) to develop and maintain data-oriented systems. Act as business embedded super user.
• Responsible for creation and maintenance of procedural documentation within scope as process owner.
• Stay up to date with best practices in the field and propose improvements of methodologies used for hazard identification.

Profile:

• Higher Degree in a relevant life science (PhD or MSc with relevant experience): (eco)Toxicology, Chemistry, Pharmaceutical science, Biotechnology.
• Some experience in Toxicology or risk assessment is an asset but not a requirement.
• An understanding of ICH regulatory requirements or the willingness to get trained in the regulations.
• Very organized, understand the value of quality and good documentation.
• Excellent interpersonal skills; enjoys working in multidisciplinary teams.
• Effective time management and the ability to meet deadlines is an important aspect of this position.
• Proactive and flexible, able to operate in a dynamic surrounding of a fast-growing biotech company.
• Our working language is English, written and spoken proficiency in English is necessary.

Offer:

• A competitive compensation package with extensive benefits
• Exposure to all aspects of pre-clinical and clinical development in the company, but also with external vendors, contract partners and the scientific world
• A work environment in a dynamic, rapidly growing biotech company

LI-onsite

• Performs toxicology risk assessments in line with pertaining regulatory guidelines with regards to manufacturing events, product impurities, extractables & leachables and excipients in accordance with argenx procedures. Supports and interacts with manufacturing (CMC), Quality, Regulatory Affairs and other functional areas (such as Medical Affairs and Global Patient Safety- GPS) to facilitate integrated health risk assessments.
• Responsible for literature searches in scope of assigned assessments. Oversees database searches that are commissioned to 3rd parties.
• Responsible for information flow between internal and external stakeholders (e.g. CMC, Toxicology, GPS, regulatory and 3rd party vendors): point of contact for such assessments. Formulates recommendations with respect of likely hazards associated with the use of the substances in humans, for the approval by PharmTox SME.
• Responsible to keep monographs and internal databases of impurities, excipients, residuals, extractables and leachables up to date.
• Responsible to receive, store and manage data of owned studies.
• If applicable, summarize data in table or other formats for inclusion in regulatory dossiers. Support analysis and visualization of nonclinical data.
• Contributes and reviews regulatory documentation with regards to area of expertise.
• Ensure owned documentation complies with quality standards (e.g. compliance with eCTD or other standards necessary for submission to health authorities).
• Interacts with internal stakeholders (e.g. Business Information System, IT) to develop and maintain data-oriented systems. Act as business embedded super user.
• Responsible for creation and maintenance of procedural documentation within scope as process owner.
• Stay up to date with best practices in the field and propose improvements of methodologies used for hazard identification