Toxicologist H/F Sanofi

Détail du poste

Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l'international, l'anglais étant la langue de travail.

This job offer is accessible to all, regardless of gender.

Job Title :Toxicologist

About the job

Project Toxicologist who will work as part of a multidisciplinary team to elaborate toxicology strategies and monitor toxicology studies for all New Vaccines & Life Cycle Management Vaccines, in compliance with applicable regulatory guidelines.

He/she will provide with necessary inputs to the project teams with regard to any non-clinical safety matters to support project progression.

The role will include the analysis and interpretation of toxicology data generated and ensure subsequent regulatory/clinical submission and compliance in the context of IND/IMPD and CTD/MAA applications.

Main Responsibilities :
- Performing quality control checks on non-clinical toxicology documents for regulatory submission
- Assists in the preparation of documents, eg, annual PBRER, investigational new drug and new drug application reports, dRMP, DSUR
- Identifies and effectively manage (including associated communication) potential safety issues : for products at the preclinical stage, under clinical development and for marketed vaccines
- Direct interaction (written or meeting) with Health Authorities as part of Global Project Team activities, where he/she represents the toxicological expertise
- Support toxicological safety risk assessments of any aspects in relation of the Vaccine development (excipients, residuals, process-/product-related impurities) by defining acceptable safety threshold to human health
- Provide toxicological support for new ingredients, process-/product-related residues where toxicological assessment is required in the context of NV projects, R&D
- Provide ad'hoc support to M&S where needed, in case of trouble shooting issue or qualification of new process materials (assessment of extractable/leachable data), new excipients/ingredients

About you
- Toxicologist by training, with at least 5 years experience, ERT or DABT
- Work as a fully autonomous project toxicologist
- Excellent communication skills
- Team spirit, open to constructive, scientific, challenge
- Work within the Non-Clinical Safety department & in relation with the broader NCS & Predictive Sciences Department

Why choose us?

We provide a highly open and collaborative environment, with an opportunity to work with a world class team. You will BE able to :
- Learn what IT takes to make a service with a truly global reach
- BE part of an organization that values diversity, inclusion, and the richness of different backgrounds and experiences
- Engage in meaningful work that combines the challenges of pharma, manufacturing, environmental matters and technical fields, offering abundant opportunities for professional growth and impact
- Contribute to a company that is not only a leader in healthcare but also a pioneer in digital transformation, shaping the future of global health

Pursue Progress. Discover Extraordinary

Progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing : a desire to make miracles happen. You can BE one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let's pursue progress. And let's discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our and check out our Diversity Equity and Inclusion actions at !

#LI-FRA

#LI-Onsite

La diversité et l'inclusion sont les piliers de la manière dont Sanofi fonctionne et font partie intégrante des valeurs de la société. Nous respectons la diversité de nos collaborateurs, tout comme celle de leurs parcours et expériences. Afin de bénéficier de la richesse qu'apporte la diversité, Sanofi s'engage à donner l'exemple en matière d'inclusion et à favoriser un environnement de travail où les différences peuvent prospérer et contribuer à aider les patients à retrouver une vie meilleure.

Dans le cadre de son engagement diversité, Sanofi accueille et intègre des collaborateurs en situation de handicap.