Job Purpose and Key Responsibilities:

The essence of the Expert Systems Configuration II is to work with a high level of independence to achieve one or more of the following:

• Provide expertise and guidance to the team members in completing the configuration tasks
• Extensively support in resolving the complex tasks or time sensitive business requests
• Is a Subject Matter Expert and understands, articulates and implements best practices related to Configuration
• Strong experience in project management. Ability to lead project teams of various sizes and see them through to completion with minimum supervision
• Experience in preparing and coordinating for audit/inspection programme and contribute in resolving the audit/ inspection findings for the team
• Expert in assessing the new config activity/task. Performs fit-gap analysis of new process being implemented.
• Involvement in Global Projects. Ensuring efficient project management procedures are implemented to enable monitoring of projects
• Conduct management monitoring to ensure set quality standards are met and process or procedures are being adhered to. Identify and report the trends.
• Analyze and prioritize various improvement ideas within the team. Effectively execute the process improvement ideas and implement them.
• Plan and review the fit for purpose training required for the team
• Gain technical competencies outside of the team (when applicable)
• Accommodate additional technical requests from various business units
• Performs other duties as assigned
• Support the configuration and data quality of the OASIS system. Interactions will include SDS (Safety Data Services) Configuration Management Technical Managers, SDS Application Support and Reporting teams, OASIS users, GSK source system teams and IT vendors/suppliers.
• Ensure that the design, implementation, maintenance and support of OASIS Systems Configuration enable GSK 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.
• Provide a clearly-defined communication channel between stakeholders and end-users of Pharmacovigilance computer systems and IT service providers in the key areas of systems delivery, systems validation and systems support.

Accountability:

• Systems Validation : The documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. 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.

• Training: Education or instruction to end-users or other stake holders using efficient and effective communication and structuring of complex changes into a form relevant and applicable to the operational needs of users.

• 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 OASIS system configuration support as well as managing helpdesk requests. Work across the organization to resolve end-user requests and incidents in a timely manner.

Complexity (this is best illustrated for this role by the behaviors needed to perform effectively):

• Leadership : Understand how your work supports the team’s goals and the organizational priorities and applying sound judgment to all that you do.
• Decision Making: Makes well thought-out yet efficient decisions based on pertinent facts, relevant information and good judgment. Identifies key issues, analyses cause-effect relationships, clarifies input from different sources, and reaches appropriate decisions in a timely manner.
• Embracing Change/Innovation: Questions the status quo. Generates new ideas. Recognises the need for new or modified approaches and brings perspectives and approaches together, combining them in creative ways.

• Teamwork: Works effectively with others to achieve business goals and objectives. Bridges personal, business and cultural differences to work effectively in team settings.

• Business Orientation : Understanding of the operational challenges of safety stakeholders and other customers. Recognises issues and initiatives important to the business in order to facilitate development of business benefits cases and effective prioritisation in order to move the business forward.

• Customer Focus: Understands their (internal and external) customer’s business. Understands customers’ needs and works with them to help solve their problems. Acts quickly to respond to customers’ needs.

• Communication: Listens to others: actively attends to and conveys understanding of the comments and questions of others; listens well in a group. Speaks effectively: speaks clearly and expresses self well in groups and in one-to-one conversations. Writing skills: conveys information clearly and effectively through both formal and information documents; reviews and edits written work constructively. Delivers presentations effectively: prepares and delivers clear, smooth presentations; carries self well in front of a group. Strong influencing and negotiation skills.

Responsibilities :

Role will have to ensure adherence to GSK’s and external regulators’ computer system validation guidelines for developing and maintenance of PV systems while independently interacting with OASIS system users (Global, Japan, Local Operating Companies, and Vendors) with specifications in one or more of the following areas:

• Expert in completing assigned configuration requests per the approved processes including accurate documentation of the updates
• Expert knowledge of the concepts related to PV Systems configuration
• Serves as single point of contact for any configuration related business queries
• Active participation in projects and aid management with escalation issues related with high business impact or risk
• Expert in trouble shooting of issues and resolve tickets with respect to Configuration
• Expert in Console Codelist Changes, Console Business Configuration and Pharmacovigilance
• Expert in advanced business configuration requests
• Expert in prioritizing the process improvement ideas and executing them effectively
• Independently assess the impact of configuration changes to the PV System and integrated interfaces
• Independently interact with relevant stakeholders/teams, to communicate any configuration change
• Expert in working with OASIS system users to organize and complete large configuration tasks independently
• Expert in completing the quality control activities to verify configuration changes
• Extensive knowledge of the internal reporting tools. Being able to query the wizards or verify the Cognos reports related to configuration and resolve the issues, if any.
• Being audit ready. Participate and coordinate the audit/inspection programme and contribute in resolving the audit/ inspection findings for the team
• Perform other duties as assigned

Competencies:

• Expert 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
• Good knowledge of on the job reporting tools, which includes but not limited to Excel, PowerBI, Qlick View etc.
• Expert at PV systems skill, including: Safety database knowledge, Incident/Problem management process and SQL/other query language tools
• Expert knowledge of the concepts in safety system configuration, which includes but not limited to Family, Product, Licence, Study, Project, Codelists, Regulatory Reporting Rules, Advanced conditions, Auto Narratives, Workflow, other system Configuration items and reference systems
• Logical thinking to perform independent analysis resulting in comprehensive requirement definition or problem resolution
• Good at critical thinking and solution oriented
• Expert in coaching and influenzing team members of lower grade
• Excellent influencing and negotiation skills
• Expert knowledge of incident, problem, knowledge and change management processes and best practices
• Expert knowledge of medical and drug terminology, clinical safety and pharmacovigilance data, or equivalent experience working to support query and reporting environments in other domains
• Expert understanding of GxP testing and validation processes
• Ability to work independently within tight deadlines while under pressure, while maintaining a high level of accuracy, attention to detail and integrity.
• Ability to complete projects or tasks at varying levels in size and complexity
• Knowledge of global organization structure for interaction with stakeholders and users worldwide
• Proficient in stakeholder management and customer focus
• Bridges personal, business and cultural differences to work effectively in team settings.
• Results driven with a sense of urgency that ensures timelines within personal control are met
• Demonstrates learning agility inline with the evolving needs of business
• Develops self and others

Education –

Bachelor/Master degree (Information Management/ Technology, Computer/scientific or medically related field is preferred) with a minimum of 9-12 year working experience in the pharmaceutical industry in clinical development, pharmacovigilance and information management or equivalent work experience.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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