Systems Specialist Reporting and Analysis

Job Purpose :

The essence of the Systems Specialist Reporting and Analysis role is to provide a clearlydefined communication channel between Client safety systems stakeholders / users worldwide, Regulatory Authorities, Safety teams, and IT vendors and suppliers in three key areas systems delivery, systems validation and systems support.

The key systems management activities are :

SQL / Cognos / PowerBI Report Development

Data Analysis

Systems Validation

Systems Support and Maintenance

The position requires demonstrated skills in a range of these roles as measured in the eyes of customers and be able to cover all of the roles with an adequate level of skill when necessary.

Collaboration for safety systems users in this role with be focused on Asia Pac stakeholders.

This position ensures that the design, implementation, maintenance and support of PV systems enable Client to efficiently, timely, accurately, and consistently report and analyze data from all relevant data sources to support the full range of PV activities, ensuring effective monitoring of the safety of our marketed products and investigational compounds.

Key Responsibilities (suggested no more than 10 bullet points) :

Japanese language skills

SQL / PowerBI Report Development : Develop and implement SQL / PowerBI custom reports for end users, provide complex query and reporting support for end users, write complex SQL queries to extract data and performing data analyses for end users and support the overall reporting environment configuration / safety database and DataMart.

Data Analysis : Extracting, inspecting, cleaning, transforming and modelling raw data with the goal of highlighting useful information, suggesting conclusions and supporting decision making.

Systems Validation : The documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. Plan, execute, report on user acceptance testing and archive test findings for diverse regulated systems. Be able to produce evidence of systems validation to internal and external auditors.

Support : Respond to client or end-user requests by diagnosing and resolving problems and incidents that fall within defined guidelines and / or escalating or transferring problems and incidents to other technical support teams and / or outside vendors as appropriate to ensure ongoing business operations. Knowledge and understanding of user needs when issues are raised and provision of timely and expert resolution and advice.

Support includes but is not limited to query and reporting support as well as managing helpdesk requests.

Work across the organization to resolve end-user requests and incidents in a timely manner.

Education Requirements (minimum expected) :

Bachelor / Master degree in an information management, SQL development experience, business analytics, data query / reporting environments or related field with minimum of 4-9 year s experience in the pharmaceutical industry in clinical development, pharmacovigilance and information management or equivalent work experience.

Job Related Experience (minimum requirements) :

Good understanding and experience with SQL / PL-SQL development / query language tools

Experience working in Power BI or other data modeling and reporting tools.

Working knowledge of Data Virtualization tools (Denodo)

Knowledge of data caching and implementing connections to multiple sources through data virtualization tools

Experienced in scheduling management in PowerBI.

Good at developing and extracting reports from DataMart using Cognos or PowerBI, Examples are like list reports, cross tab reports, drill through reports, etc.

Good knowledge of report development in Cognos and / or Power BI and / or OBIEE

Experienced in development of reports (using native SQL and Cognos studio or PowerBI) based on end user requirements.

Good knowledge and working experience in Cognos / Power BI administration and scheduling management.

Good at Cognos / Power BI Framework Management and changes to Data modelling

Knowledge of Argus database / DataMart structure.

Experience supporting in ad-hoc data requests and report request / issues.

Thorough knowledge of clinical safety and pharmacovigilance data, or equivalent experience working to support query and reporting environments in other domains.

Good at responding to and supporting help desk request within query and reporting environments.

Proficient in knowledge of incident, problem, knowledge and change management processes and best practices.

Good in business analysis capable of documenting requirements based on end user input.

Good understanding of GxP testing and validation processes with minimal supervision for senior staff

Good in writing report specifications / requirements documents with minimal supervision for senior staff.

Good in writing and executing GxP System and User acceptance test documents with minimal supervision for senior staff.

Good knowledge of the data querying and reporting tools used to generate aggregate reports (Cognos, Qlik, Power BI, Spotfire, others) knowledge of medical and drug terminology.

Active participation during audits and inspections with supervision from senior staff

Ability to work with tight deadlines while under pressure, while maintaining a high level of accuracy, attention to detail and integrity.

Functions as a team player

Ability to work independently.

Proficient in stakeholder management and customer focus

Other Job-Related Skills :

Excellent in oral and written communication skills including :

Ability to identify and communicate issues in timely fashion to both end-users and central resources.

Experienced in business analysis capable of documenting requirements based on end user input.

Experienced in responding to and supporting help desk request within query and reporting environments.

Excellent computer skills including Word, Excel, PowerPoint and SharePoint.

Expert in systems skill including Safety database, Incident / Problem management tool and SQL query language tool.

Thorough understanding and experience in Cognos / PowerBI report development using SQL / PL-SQL and other query language / tools.

Good understanding of building models using PowerBI.

Knowledge of Denodo implementation / Data virtualization tools.

Excellent skill in managing the reporting environments and building models as per the business requirements.

Good understanding of reporting environment setup and its integrated components.

Thorough knowledge of Cognos administration and framework management.

Expertise in resolving diverse business needs in terms of query and report environments.

Expert knowledge of clinical safety and pharmacovigilance data, or equivalent experience working to support query and reporting environments in other domains.

Logical thinking to perform independent analysis resulting in comprehensive requirement definition or problem resolution with minimum supervision from senior staff.

Good in business analysis capable of documenting requirements based on end user input.

Thorough understanding of GxP testing and validation processes

Proficient in writing report specifications / requirements documents

Proficient in writing and executing GxP System and User acceptance test documents.

Expert in responding to and supporting help desk request within query and reporting environments.

Expert knowledge of incident, problem, knowledge and change management processes and best practices.

Excellent understanding of the data querying and reporting tools like Cognos, QlikView, Power BI, Spotfire, others.

Expert knowledge of medical and drug terminology.

Good at multitasking and prioritization.

Good in coaching and influencing team members of lower grade.

Bridges personal, business, and cultural differences to work effectively in team settings.

Basic knowledge in resource and team management skills

Proficient in stakeholder management and customer focus

Develops self and others.