IT Business Partner, Pharmacoviglance & Epidemiology

The IT Business Partner for Global Pharmacovigilance and Epidemiology is accountable for evolving strategic information systems that enables Global Pharmacovigilance and Epidemiology (GPVE) organization to ensure patient safety and compliance with global regulatory requirements.   This role is within the Information Technology group and will partner with other IT resources, outsourcing partners, vendors and functional area leads within GPVE to define, plan for, prioritize, deliver & support strategic information management capabilities and to ensure maximum value is achieved. Specific responsibilities include: Proactively translate business strategies into multi-year capability roadmaps and translate those roadmaps in toactionable informatics programs and projects. Responsible for identifying digital capabilities that have the greatest impact on patient safety and product development, set the right expectations, and ensure that IT delivery resources are appropriately engaged to fulfill the business outcomes.    Implement program/project governance processes and change management efforts that ensure successful projectexecution and achievement of high value business outcomes. Partners very closely with adjacent IT teams supporting clinical operations, regulatory and medical to ensure that capabilities supporting the pharmacovigilance and epidemiology functions are identified and addressed. Matrix leadership of IT resources in other IT functions ensuring that all IT functions are successful in their delivery of services to GPVE.  Key matrix IT partner functions include platform architecture, software engineering, application support & maintenance,  program management, information & data management, collaboration services, infrastructure services. Lead and facilitate process engineering based on detailed and practical knowledge of the broad range of systems and processes that support global pharmacovigilance and epidemiology sciences. Proactively research industry and technology trends to inform strategic planning and translate to potential opportunities. Key Competencies: Must have at least 10 years of experience in a Pharmaceutical or Biopharmaceutical environment.  BS in Science, Engineering, Information Technology or equivalent experience required.  Graduate Degree or higher level education preferred.  Strong practical working experience with Pharmacovigilance and Epidemiology, with demonstrated command of processes and systems for adverse event collection, case processing, ICSR and aggregate reporting, signal detection and safety analytics.  Experience with Argus, Empirica and E2B is preferred.   Knowledge of new technologies for processing automation, digital AE collection and safety analytics is a plus. Demonstrated strategic leadership & track record of maintaining effective business relationships with Senior Management to ensure Informatics can deliver solutions that align with business strategies and objectives. Demonstrated experience with IT road map creation and portfolio planning. Proven abilities to plan, manage, and deliver strategic programs, from concept initiation through delivery. Demonstrated ability to conduct business analysis, requirements specifications and business change management.    Experience in evaluating commercial products (e.g., software packages) and services and influencing the negotiation process for vendor products. Working knowledge of GxP regulations and delivery of informatics projects in a GxP environment.  Must possess excellent written and verbal skills and demonstrate an ability to effectively communicate at all levels of the organization including executive stakeholders.   Ability to achieve successful consensus among differing priorities and stakeholders in both the IT and Business communities. Effective in cross-functional, multi-site, matrix management and team building. R1118725
Salary Range: NA
Minimum Qualification
11 - 15 years

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