At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.

As a Principal Safety Informatic Scientist in Gaithersburg, MD, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. GMD (Global Medicines Development) drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.

Job Description

With an in-depth expertise in a variety of data sources/databases, the principal Safety Informatic Scientist helps customers (Patient Safety Therapeutic Areas) 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 Science. The Principal Safety Informatic Scientist seeks opportunities to utilize 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 Safety 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 assigned GRAPSQA  customer groups and wider stakeholders, including those in senior roles, to plan and provide strategic-enabling support and/or routine service delivery, as required.
• Advises relevant customer groups on appropriate approaches and strategies to address their information requirements, ensuring development and awareness of good  practices and methodologies where appropriate.
• 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).
• Supports new innovations, projects and capability developments that enable the delivery of high quality, enabling informatics and analytic services for Patient Safety TA customers and stakeholders.
• Oversees or provides expert technical support to customers  on a global basis
• Leads or oversees a diverse range of initiatives to improve quality, integrity of information interpretation, cost or time
• 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 in applicable areas of expertise through innovative and continuous improvement aligned with best practice across the industry.
• Collaborate closely across the global GRAPSQA organisation, with stakeholders, IS vendors, and other experts involved in the design, development and delivery of information solutions, or related business deliverables such as policies, procedures, processes and guidance.  Maintains awareness of opportunities to co-develop and/or utilize wider information resources with collaborative partners to address common cross-functional business needs.
• 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 utilized 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
• A sound understanding of clinical safety, or related pharmaceutical industry experience, preferably with extensive involvement in the successful design, delivery or deployment of information/systems solutions to address scientific safety-related requirements.
• 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.

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 IS 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 IS developments within AZ or the pharmaceutical industry, particularly in relation to the design and deployment of data sources, analytical tools, informatics solutions and systems.
• Experience across multiple therapeutic or business areas, or in working in safety-related roles within other biopharmaceutical, regulatory, or health organizations.
• Key capabilities commensurate with the Global Career Level of the role (e.g. Leadership Capabilities)
• 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.
• Experience in working across different geographic locations, organisations, and cultures to drive vendor and customer relationship management.

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.

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.