In this role you will…
- Provides expert toxicology review of GSK Safety Data Sheets (SDS) for GSK drug substances, intermediates, mixtures, products etc. Interfaces with SDS authors to ensure timely and accurate development / updates;
- Provides expert toxicology assessments (human health hazard assessments) and guidance for GSK products and process materials across global span of GSK, including development of Health based exposure limits (HBELs): Occupational exposure limits (OELs), Permitted Daily Exposure (PDE) Limits for various modalities (small molecules, peptides, biologics, oligonucleotides, etc)
- Provides worldwide training and support in toxicologically related topics, establishes and maintains processes to enable effective communication and education of key stakeholders, maintains the global EHS toxicology database;
- Support to worker safety testing programs at external toxicology labs relevant for hazard characterization for new product and to support chemical registration data requirements
- Contribute to projects to ensure regulatory compliance; authoring and/or reviewing reports, protocols, guidelines and standard operating procedures (SOPs) and ensuring harmonized approaches with regard to the toxicological assessments;
- Monitor scientific developments and conduct desktop research including literature searches, and critically evaluate and summarise scientific information and government regulations.
- Maintain toxicological expertise relevant to nonclinical safety of drugs, occupational health, and product quality risk, i.e. keeps up to date with the scientific literature and regulatory guidance, attends and contributes to relevant professional/scientific meetings, and publishes in peer reviewed journals, if appropriate
Why you?
Basic Qualifications
We are looking for professionals with these required skills to achieve our goals:
- Significant experience in toxicology field
- BSc degree or equivalent in toxicology/pharmacology or related
- Research skills with literature searches, toxicology databases, regulatory databases and computational tools
- Project planning, tracking and management skills to ensure actions and commitments are delivered to plan
- CI minded
- Ambitious, proactive and motivated
Preferred Qualifications
If you have the following characteristics, it would be a plus:
- Experience in regulatory toxicology, gained in pharmaceutical / biopharmaceutical, chemical, or related product manufacturing
- Masters degree or equivalent in toxicology
- Professional Qualification/Certifications (e.g DABT, ERT or similar).
- An understanding of Globally Harmonized System (GHS) for classification and labelling of chemicals and the EU Classification, Labelling and Packaging (CLP) regulation and other relevant global regulations
- Knowledge of global chemical regulations and hazard assessments