Pharmaceuticals

Pharmacovigilance Business Application Manager

Permanent

Vignetic

Pharmacovigilance Business Application Manager Princeton, NJ

Title: Senior Business Application Manager

Job Type: Permanent

Primary Location: Princeton, New Jersey

The Challenge:

Vignetic is looking for a Senior Business Application Manager who will be part of the Business Applications Management (BAM) Team within the Global IT department, based out of Princeton, New Jersey.  In this role, the candidate will manage multiple business applications in Production environment and ensure compliance with applicable procedures and regulatory requirements.

Role & Responsibilities:

  • Define the pharmacovigilance technology strategy with business stakeholders, technical teams, and ensure business impact solutions are implemented through out-of-box and customized solutions.
  • Access processes and identify opportunities to improve efficiency, effectiveness and compliance and lead projects to the implementation of process improvements.
  • Manage Argus system changes to ensure accurate and timely assessment of impact to global PV process.
  • Maintain standards and procedures for identification and management of Product Quality Complaints associated with safety information coordination with other PV functions and QA units related to triage, case processing, investigation, reconciliation, and reporting.
  • Perform impact analysis for global regulatory intelligence results and assist PV Process as SME during audits and inspections.
  • Manage planned and unplanned deviations and ensure accurate periodic review.
  • Establish strong strategic relationships and act as point of contact across business stakeholders to develop a deep understanding of the business strategy and operations.
  • Partner with cross functional IT & Drug Safety teams to integrate technology solutions and manage product lifecycle projects, change requests, enhancements, and releases.
  • Advise, inform, and support the application system owners and super-users and act as a first line of support for business application related issues or requests.
  • Conduct root cause analysis, in collaboration with other cross-functional stakeholders, to identify potential solutions to issues and to prevent future problems.
  • Manage day-to-day user cases, including (but not limited to) new user requests, resolution of operational systems issues, and troubleshooting of various business applications in scope.
  • Provide periodic financial reports and budget plan, vendor issues report vs SLAs to the Business Applications Management (BAM) Lead.

 

 

Essential Skills & Requirements:

 

  • Extensive experience with Pharmacovigilance and Drug Safety Solutions (e.g. Oracle Argus suite of products, IQVIA technologies)
  • Hands-on experience of Oracle Argus Safety products including environment recommendations, cross-platform integrations, customizations (configuration and E2B profiles) and related IQ, OQ, PQ activities
  • Knowledge of WHODRUG and JDRUG dictionaries, MedDRA dictionary, AgXchange, and Axway (EDI Gateways)
  • Knowledge of periodic reports to regulatory agencies like FDA, PMDA, EMA
  • Over 10 years’ experience coordinating application-based activities within a life science focused organization
  • A scientific/technical degree level qualification (e.g. Computer Science)
  • Proven experience of agile management and DevOps
  • Demonstrated knowledge of the ITIL framework and working in a ticket/SLA based environment (i.e., ServiceNow, JIRA)
  • Experience and ability to thrive in ambiguous situations and delivery value in a dynamic environment
  • Strong experience in liaising and managing third party vendor managed services where required to support the application portfolio and integration layer
  • Experience with KPI performance monitoring and SLA management across internal service desk and support vendors
  • Excellent interpersonal communication skills and multicultural awareness; strong personal integrity, and teamwork abilities
  • 10% international travel availability throughout the year

 

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Tagged as: Pharmacovigilance Business Application Manager