Major accountabilities:

• With the support of Asso. Director. Systems Management facilitate discussions to help Global Development to anticipate future needs and opportunities and communicate where technology can help.
• Work with Systems Management colleagues to raise new project proposals and mandates and support definition of the business case, conduct assessments of processes and detail requirements
• Collaborate with project teams to determine scope, goals and objectives
• Guide the Business lead to definite business value and associated metrics
• Interview business partners, organize and run requirements sessions with groups of users.
• Analyse and model relevant business processes, rules and data and relationships by documenting the “as is” process and provide guidance to the business analyst to create the “to be” process
• Determine data flows and sources; prepare data conversion or migration needed to support goals and uses in a process.
• Collaborate with project team to define solutions that deliver business value.
• Contribute to outlining performance qualification testing and validation plans.
• Analyze, Understand, Collect, Test, Implement, and Maintain safety database configuration changes functions from Global Development and External line functions. An understanding of functional area and IT domain is required.
• Perform QC check on configuration changes, identify discrepancies between the request and the implementation and resolve or initiate their resolution.
• Understand Global Development processes to support and lead process improvement initiatives.
• Perform the role of first line operational support for safety database users and provide system administration support for Global Development applications as appropriate
• Develop; provide support to create complex specialized reports from PS&PV systems as appropriate.
• Coach, train and mentor new Experts Systems management as appropriate and bring them to the next level.
• Facilitate audit and inspection preparedness, and lead discussions with auditors and inspectors.
• Assume full responsibility for routine operations and projects, whether as an individual contributor, team leader, or system owner.
• Ensure system traceability and adhere to proper documentation practices to manage and maintain technical and procedural artifacts.
• Collaborate effectively with external service providers and support governance and performance activities.

Minimum Requirements:
Work Experience:

• Collaborating across boundaries.
• Project Management.
• At least 7 years’ experience in drug development in the area of safety database administration and support.
• At least 4 years in the discipline of safety data management.
• Experience with ORACLE, SAS databases.
• High level of competence with SQL.

• Thorough understanding of MedDRA, Disease dictionaries
• Broad and in-depth knowledge of Drug safety business processes.
• Thorough understanding of the issues aligning IT solutions with business needs.
• Excellent mentoring and coaching skills
• Ability to form, lead, and deliver initiatives

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