Senior GPS Systems Manager

United Therapeutics•Silver Spring, MD

12h•Remote

About The Position

United Therapeutics Corporation seeks a Senior GPS Systems Manager in Silver Spring, MD to Plan, define and execute the high-level computer applications systems analysis necessary to maintain global pharmacovigilance (PV) computer and data systems for the management of the company’s safety data and to ensure the security and integrity of this safety data. Plan and implement optimal systems solutions for the organization's drug safety and PV systems to ensure compliance and data integrity, while also implementing improvements as a result of automating certain IT processes to increase efficiencies and reduce outsourcing costs. Analyze information-technology systems needs and translate these business requirements into detailed technical requirements. Perform system support and configuration planning, and/or application modifications in a compliant manner. Develop, maintain, and oversee full implementation of relevant procedural documents, and templates, including but not limited to SOPs. Provide technical workarounds to the systems engineering and development teams to resolve complex system gaps. Generate and review all data extraction strategies including SAE reconciliation, inspection/audit reports, trending analysis, and other routine business reports. Ensure the compliance of PV computer systems and databases as it relates to regulatory inspections and audits. Ensure relevant data-systems security checks are performed in timely manner for all safety systems. Work with GPS & PV systems vendors to ensure that all safety systems and database are appropriately patched in timely manner. Plan and execute ad hoc database pulls and/or custom report developments to meet business requirements. Will be responsible & accountable for the maintenance of safety applications & tools (data analytics, data entry, medical coding, systems integrity, configuration support, systems compliance, e2b support etc.). Serve as a key contributor for the company’s GPS & PV function ensuring business application systems continuity. Plan and execute integrations, validation, and support User Acceptance Testing(s). Propose improvements/efficiency gains for business processes and support process excellence using a computer information systems perspective.

Requirements

Bachelor's degree or foreign equivalent in Computer Science, Computer Engineering or Software Engineering, and 9 years of experience in the position or in a related computer systems analyst, computer programmer or software engineer position.
OR Master's Degree or foreign equivalent in Computer Science, Computer Engineering or Software Engineering, and 7 years of experience in the position or in a related computer systems analyst, computer programmer or software engineer position.
7 years of experience conducting computer and systems analysis to support the management of Drug Safety Systems.
7 years of programming experience employing PL/SQL, C++, MS .Net Framework.
3 years of experience optimizing the use of the Argus Safety software platform.
3 years of experience executing Business Intelligence reporting employing either Cognos, Business Objects, or OBIEE.

Responsibilities

Plan, define and execute high-level computer applications systems analysis for global pharmacovigilance (PV) computer and data systems.
Ensure the security and integrity of safety data.
Plan and implement optimal systems solutions for drug safety and PV systems.
Automate IT processes to increase efficiencies and reduce outsourcing costs.
Analyze information-technology systems needs and translate business requirements into detailed technical requirements.
Perform system support and configuration planning, and/or application modifications.
Develop, maintain, and oversee full implementation of relevant procedural documents and templates, including SOPs.
Provide technical workarounds to resolve complex system gaps.
Generate and review all data extraction strategies, including SAE reconciliation, inspection/audit reports, trending analysis, and other routine business reports.
Ensure the compliance of PV computer systems and databases for regulatory inspections and audits.
Ensure relevant data-systems security checks are performed in a timely manner.
Work with GPS & PV systems vendors to ensure timely patching of safety systems and databases.
Plan and execute ad hoc database pulls and/or custom report developments.
Maintain safety applications & tools (data analytics, data entry, medical coding, systems integrity, configuration support, systems compliance, e2b support etc.).
Ensure business application systems continuity for the GPS & PV function.
Plan and execute integrations, validation, and support User Acceptance Testing(s).
Propose improvements/efficiency gains for business processes and support process excellence.