Job Description

Work Schedule

Environmental Conditions

Purpose:

Subject matter expert of day-to-day application configuration and maintenance activities of the Pharmacovigilance (PV) Safety database Oracle Argus, ensuring that performed tasks comply with SOPs and policies, industry standards, and applicable regulations. Provides technical solutions, support systems implementation and testing following change control procedures and provide systems administration to support the requirements and initiatives of the PV Safety group.

Responsibilities include but are not limited to:

• Collaborates with PV business users to understand the requirements and recommend solutions.
• Creates custom and ad-hoc reports from the PV Safety database using built in tools, OBIEE, or SQL.
• Develops and validates aggregate safety reports.
• Troubleshoots and addresses end user queries related to the Safety database.
• Supports routine dictionary upgrades.
• Liaises with PV Safety database vendor for system upgrades and enhancements, issue resolutions and on-going projects.
• Assists in the development of SOPs for the PV Safety database.
• Assists with internal and external audits of the PV Safety database.
• Manages changes to the PV Safety database under PPD change control policy, including configuration changes and system upgrades.
• Creates new tenants within the PV Safety database.
• Develops distribution rule configurations within the PV Safety database.
• Leads data migration and validation projects including creation of Data Migration Plans, Design Specifications and Summary Reports to ensure data migration activities meet requirements, are complete and accurate and delivered to a high-quality.
• Interacts with project team or client and seeks feedback on deliverables.
• Provides programming support to project teams and clients for safety data review, ad-hoc reports and other activities.
• Leads project initiatives as needed, ensures desired outcome is achieved on time and in scope.
• Reviews and makes recommendations for process development and improvement.
• Manages assignment to meet timelines and deliver high quality work.
• Estimates effort to assist in bidding activities or cost construction.

Qualifications:

Education and Experience:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)

Knowledge, Skills and Abilities:

• System administration experience in Oracle Argus including current knowledge of safety system configuration, database structure, mappings requirements and transformation rules
• Strong experience generating reports
• Strong SQL programming skills
• Demonstrable record in safety data migrations
• Knowledge of relational data base structure and experience working with complex data systems
• Proficient of one or more programming languages
• Strong attention to detail
• Problem solving skills
• Good written and verbal communications skills
• Ability to independently and effectively organize and manage multiple assignments with challenging timelines
• Ability to adapt and adjust to changing priorities
• Demonstrated leadership, initiative and motivation
• Ability to mentor and direct the work of junior staff
• Ability to communicates effectively within a multi-disciplinary team
• Ability to complete assigned tasks on time and within budget

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