Safety Informatician

With an in-depth expertise in a variety of data sources/databases, the Safety Informatician helps Patient Safety Center of Excellence (PS CoE) and AZD1222 project team to gain full value from information sources, analytics, and technologies. The role holder contributes to the development of the informatics/information science strategy and is responsible for their implementation planning and execution. The role holder proactively drives innovative approaches to informatics and analytics to meet the needs of Safety Analytics group and AZD1222 project team. The Safety Informatician seeks opportunities to utilise new or existing information assets and successfully manages relationships with stakeholders across the business. The role will collaborate very closely with customer teams, relevant leaders within Patient Science Center of Excellence and wider enabling roles in the business, to ensure optimal delivery of informatic services.

Typical Accountabilities

• Delivers global subject matter expertise in defined areas of informatics and analytics support. Working in close collaboration with AZD1222 project team, PS CoE, and wider stakeholders, including those in senior roles, to plan and provide strategic-enabling support and/or routine service delivery, as required.
• Integrates and summarises complex data & information across multiple domains. With the ability to leverage in-depth skills & knowledge to support data analysis, reporting and visualization needs, as appropriate.
• Ensures that relevant data/information standards and quality levels are defined; business rules for data acquisition are developed; and integrated analysis & modelling approaches can be utilised for a variety of safety information sources.
• Communicates relevant approaches and findings effectively with customer and stakeholder teams, to confirm understanding and validate that underlying scientific and business questions are appropriately addressed.
• Ensures that relevant information assets are developed and managed in ways that enable effective sharing, re-use, accessibility, and quality.
• Coaches colleagues within relevant customer or peer groups, to support ongoing best practice and skills development (e.g. in relation to the use of relevant tools and techniques).
• Oversees or provides expert technical support to customers on a global basis
• Ensures that all work is carried out with regards to AstraZeneca standards and external regulations
• Coordinates the effective use of relevant data sources, tools and methodologies to ensure existing processes and systems, relevant to informatics, can fully address the needs of customers and stakeholders.
• Identifies opportunities to lead change management in applicable areas of expertise through innovative and continuous improvement aligned with best practice across the industry.
• Supports the overall improvement of enabling activities relating to informatics; including troubleshooting problems & developing solutions. Responsible for ensuring that user support arrangements are defined as required.

Education, Qualifications, Skills and Experience

Essential
• Bachelor’s degree in a scientific or information sciences discipline, with an understanding of how information is utilised to support safety and benefit-risk activities as part of bio-pharmaceutical drug development.
• Proven technical competence, with hands-on experience, in identifying and delivering informatics and analytics solutions in complex business settings.
• Knowledge of relevant data sources, informatics, and analytics tools and database structures.
• Able to work with a high degree of autonomy
• Broad knowledge of the safety information and analytics tools required to support drug development, including a comprehensive understanding of clinical trials, regulatory safety requirements, pharmacovigilance practices, epidemiology practices, and safety project team activities.
• Experience in safety signal management and/or the exploitation of clinical study safety data to define the safety profile of a products used in clinical settings.
• Able to identify opportunities to lead change through innovation – seeking continuous improvement based on strong awareness of external competitive practice.
• Knowledge of relevant areas of programming, database development and statistical analysis methods.
• Excellent interpersonal skills to influence / shape their particular area of expertise, along with the ability to understand multiple, complex business needs and identify ways in which existing or newly designed solutions could address these in an effective and efficient manner.

Desirable
• MSc or PhD in a Life Science, Computer Science or Information Science preferred
• Experience of coordinating the delivery of relevant informatics services to support of safety-related activities in the context of clinical bio-pharmaceutical development.
• Ability to articulate complex safety-related business needs in the context of systems design, architecture and development.
• Experience of a wide array of systems and platforms, databases and/or the use of semantic technologies to query data.
• Experience in integrating information across multiple domains
• Business awareness of wider developments within the pharmaceutical industry, particularly in relation to the safety survelliance of vaccine data.
• Experience across multiple therapeutic or business areas, or in working in safety-related roles within other biopharmaceutical, regulatory, or health organizations.
• Experience in working across different geographic locations, organisations, and cultures to drive vendor and customer relationship management.

ABOUT ALTEN

ALTEN is a consulting company that develops and delivers expertise for world-leading companies with consultants in technology, IT and biochemistry. We are located in over 28 countries, have our headquarter in Paris and have more than 37 200 employees, of which 88 percent are engineers. In Sweden, we have over 1 700 employees and work from offices in twelve locations. Our clients are found in industries such as Automotive, Energy, Telecom, Industry, Aerospace & Defence and Life Science, where our consultants operate throughout the product development chain.

Welcome to read more about us at alten.se or please contact Oscar Sundell, Business Manager at ALTEN at Oscar.Sundell@alten.se.

We look forward to your application!