Senior Environmental Risk Assessor
At AstraZeneca (AZ) we work together across global boundaries to make an impact and find answers to challenges. We do this with integrity even in the most difficult situations because we are committed to doing the right thing.
Global Safety, Health and Environment (SHE) exists to help AZ protect our people and the planet. We drive improvement in SHE performance, maintain compliance and otherwise protect the company’s reputation. We do this by setting strategy and providing specific SHE expertise or accessing it through the wider SHE network.
An exciting opportunity has arisen for a Senior Environmental Risk Assessor to join the Global SHE Team to support the regulatory submissions and proactive environmental stewardship initiatives for AZ products. 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 leading the supplier relationship management of environmental contract research laboratories (CROs). You will also play a pivotal role in supporting the delivery of AZ’s environmental strategy, including our work on ‘Ecopharmacovigilance’, ‘safe active pharmaceutical ingredient (API) discharges’ and environmental data transparency.
If you have a background, as well as being able to demonstrate experience in one of the following areas; ecotoxicology, toxicology, environmental fate/degradation, chemistry, 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 will include
- To lead strategic development of Environmental Risk Management Plans (ERMP) for development compounds, liaising with other functions and gaining buy in from the Global Product Teams.
- To lead 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 activities including supplier selection, 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 such as the Global Electronic Library (ANGEL) to meet AZ Regulatory Affairs submission standards and deadlines.
- To support the delivery of AZ’s environmental strategy, including our ‘ecopharmacovigilance’, ‘safe API discharges’ and environmental data transparency initiatives.
- 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.
- 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 equivalent with proven post qualification experience
- Experience in environmental fate testing / or chemistry/ or experimental ecotoxicology/ or regulatory environmental risk assessment
- 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
- Strong analytical skills and ability to interpret environmental data
- Effective English writing and communication skills
- Ability to work independently with minimal supervision
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
Please note it is anticipated that the first interviews will be scheduled for week commencing the 6th November.