Issa Safety Surveillance Systems Scientist
AstraZeneca / Datajobb / Göteborg
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hela Sverige AstraZeneca is looking to recruit a Safety Surveillance Systems Scientist to join the Information Strategy, Systems and Analytics (ISSA) function. The position can be placed in either of Gothenburg (Sweden), Macclesfield (UK), Cambridge (UK) or Gaithersburg (US).
Information Strategy, Systems and Analytics (ISSA), as part of Delivery and Enablement (D&E), is accountable for the effective governance, maintenance and enhancement of GRAPSQA (Global Regulatory Affairs, Patient Safety and Quality Assurance) systems owned by ISSA, and for delivering expert services in support of their use by the business. ISSA ensure that the company's pharmacovigilance, regulatory and legal obligations, in respect of these systems, can be fully met.
Reporting to the ISSA Section Director, the jobholder will work closely with the ISSA Lead for Safety Surveillance Systems across a defined area of the global portfolio of Patient Safety information and systems assets. He / She has generic accountabilities and duties which are common amongst their peers, as well as, responsibilities specific to the evolving technologies, regulations and standards in the area patient safety surveillance- and signal management. He / She will work to support innovative project portfolio development and is expected to aid the ISSA Lead with the identification and deployment of solutions focused on addressing current and future business needs.
The jobholder will provide technical input to support the design, development, implementation, continuous improvement, and/or optimal utilization of a defined area of the safety systems assets, including analytical and visualization tools, to meet business, partner and customer needs. He / She will understand how current and future components of the information and systems portfolio can be developed to ensure optimal benefit for the user community across Patient Safety and wider business groups to effectively deliver or exploit scientific information and knowledge; or, ensure regulatory compliance is maintained in an optimized and cost-efficient manner.
Main Duties and Responsibilities
* Provides relevant technical and procedural expertise to customers such that patient safety information is properly managed and utilized to meet regulatory compliance requirements and support achievement of the company's strategic objectives
* Identifies opportunities to align capabilities with industry best practice through promotion of innovative solutions and continuous improvement plans
* Evaluates new modules and software upgrades and assesses the impact on system quality and compliance, the user community and standardized processes
* Understands internal and external stakeholder- and business needs by translating these into requirements for future information and systems solutions
* Collaborates effectively across the Global Regulatory Affairs, Patient Safety, and Quality Assurance (GRAPSQA) organization, with internal and external stakeholders, IS vendors, and other experts involved in the design, development and delivery of information management systems and analytics solutions, and/or other related business deliverables such as policies, procedures, training and guidance
* Utilizes data visualization and reporting tools to ensure end-user evaluation of safety data is on-target and analyzed properly independent of output
* Provides support to the business on the use of statistical methods, inclusive of commonly used disproportionality analysis methods (e.g. Empirical Bayesian), to support AstraZeneca in signal detection
* Ensures technical oversight of Patient Safety information systems and resources that support global safety activities, including: signal detection, information access, integration of safety-related data, visualization and utilization of scientific safety information to aid decision making, data mining, information sharing, safety document authoring and risk communication
Essential Requirements
* Minimum of bachelor's degree in Biomedical science or computer science
* Minimum 2 years track record of achievement within the pharmaceutical industry of implementing and/or supporting computer analytics systems, within academia or the IT industry of biomedical applications
* Innovative and analytical thinking, with enthusiasm for problem solving
Desired Requirements
* Experience of safety visualization and analytics methods and tools to support drug development and safety surveillance of marketed brands, including an understanding of clinical trials design, regulatory safety obligations and good pharmacovigilance practices
* Programming skills including SAS or R and SQL
* Experience in safety signal management and reporting tools, and/or the exploitation of
If you are interested, apply now!
Welcome with your application no later than January 29th 2019 .
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.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2019-01-08ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2019-01-27
Ange följande referens när du ansöker: R-042266
Klicka på denna länk för att göra din ansökanKontaktAstraZeneca
jessica.tangefjord@astrazeneca.comFöretagAstraZeneca
AdressAstraZeneca
43183
43183 1480
KontorsadressPepparredsleden 1
Jobbnummer 4542281
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