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Lieu: Macclesfield, Angleterre, Royaume-Uni Cambridge, Angleterre, Royaume-Uni Södertälje, Comté de Stockholm, Suède
ID de l'offre 13360310
Date de publication: 10/07/2019

AstraZeneca (AZ) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular/ Renal/ Metabolism and Respiratory. Within AZ we are passionate about science and we collaborate across global boundaries to deliver life-changing medicines to patients.  We do this with integrity because we are committed to doing the right thing.

An exciting opportunity has arisen for an experienced environmental exposure scientist to join the Global Safety, Health and Environment (SHE) Team as a Senior Environmental Risk Assessor. Global SHE exists to help AZ protect our life; whether its that of our workforce, society or our planet. We seek to inspire, advocate and govern continuous improvements in SHE performance within AZ and beyond. We do this by setting strategy and providing specific SHE expertise or accessing it through our wider SHE networks and strategic partnerships.

 As a Senior Environmental Risk Assessor, the focus of your role will be on supporting our regulatory submissions and continued leadership in addressing the risks posed by pharmaceuticals in the environment (PIE).   You will be the business point of contact for the delivery of environmental risk assessments (ERAs) to meet global regulatory submission requirements in Europe and the United States. You will provide technical oversight and study management as well as manage supplier relationships with environmental contract research laboratories (CROs).    You will also play a pivotal role in supporting the delivery of AZ’s environmental strategy, including taking on the leadership of aspects of our industry leading activities; for example, ‘Ecopharmacovigilance’ and environmental data transparency initiatives or safe manufacturing discharges programme. 

To complement the existing skills within our EcoPharmacoStewardship Team we are seeking an established environmental risk assessor with experience in environmental toxicology, environmental chemistry and/ or environmental exposure assessment.  We will make the most of your skills and passion by actively supporting you as we believe in the potential of our people and we will help you develop beyond what you thought possible.

Key Accountabilities and Responsibilities may include

  • To lead the development of ERA testing requirements to support global regulatory submissions, taking into account all available data on a compound e.g. mode of action, non-clinical data, physical-chemical properties etc.
  • To coordinate and manage outsourcing and study monitoring of GLP studies outsourced to CROs; including drafting/reviewing and finalising study protocols and reports to meet regulatory deadlines; management of material transfer to CROs.
  • To conduct ERAs for AZ products and compile ERA documents within document management systems to meet AZ Regulatory Affairs submission standards and deadlines.
  • To manage and supervise research projects to support our pharmaceuticals in the environment leadership, with a particular focus on developing tools and models for higher tiered environmental exposure assessment.
  • To lead key aspects of our pharmaceuticals in the environment strategy and our industry leading environmental risk management initiatives.
  • To manage and supervise research projects to support our pharmaceuticals in the environment leadership.
  • To undertake the technical review of safe API discharge assessments, identifying potential risks and working with AZ sites and third-party suppliers through AZ’s Global External Sourcing function to ensure safe discharges are maintained and margins of safety increased.
  • To support AZ’s chemical registration activities and environmental classification of compounds under GHS and EU CLP regulations.
  • To provide support to AZ SHE functions as required, where ERA may have an impact on their activities.  Similarly, to provide support as required to AZ procedures and projects, which require ERA involvement.

Skills and Experience

  • Science degree or higher degree (e.g. PhD) with proven post-qualification experience
  • Experience in environmental exposure assessment, environmental toxicology, mode of action-based toxicity, environmental uptake and metabolism
  • Strong data analytical capabilities and ability to interpret environmental data
  • Detailed knowledge of regulations for environmental hazard and risk assessment
  • Experience in, or a good understanding of, the principles of GLP, preferably have experience as a Study Director and/or Principal Investigator and/or Study monitor
  • Effective English writing and communication skills
  • Ability to work independently with minimal supervision

Applications should be submitted no later than midnight on (18th October 2019). It is anticipated that interviews will take place in early November in Alderley Park, Cheshire, UK.

This role is envisaged to be based at one of our key sites in the UK (Cambridge and Cheshire); Sweden (Gothenburg or Stockholm); however, other locations may be considered.

Senior Environmental Risk Assessor
Sécurité, santé et sciences de l'environnement

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