Senior Manager, Safety Systems and Data Analytics

Company: Green Key Resources
Location: Somerville
Posted on: June 18, 2022

Job Description:

The Senior Manager, Safety System Support and Data Analytics will be responsible to implement and support use of the Safety Database(s) and other technical solutions to assist the Global Patient Safety and Risk Management staff in the medical/regulatory oversight of global pharmacovigilance activities Responsibilities:Proactively collaborate with internal stakeholders to determine appropriate departmental/company solutions for extraction and analysis of safety data. Experience in BI Publisher, Argus Analytics (OBIEE) is preferred.Responsible for the generation of formal reports, summaries, and listings in support of medical monitoring, signal detection and aggregate reporting deliverables (PBRER, DSUR) in conjunction with the database service providerSupervise and monitor the activities performed by vendors.Manage and administer global safety database.Work collaboratively with other groups (e.g., IT validation, Quality Systems Validation) to implement vendor system solutions and ensure systems meet regulatory standards.Develop SOPs relevant to the use and maintenance of the reporting tools to ensure inspection readiness. ---Provide support and education on Safety and Analytics systems to end users, and coordinate training for safety solutions.QualificationsBS Computer Science/equivalent qualification Minimum six (6) years in the pharmaceutical industry with experience in managing drug safety/risk management databases and interface tools, supporting pre- and post-approval products.Must be knowledgeable about the global safety reporting requirements and ICH E2B guidelines governing the global reporting of adverse events on investigational and/or marketed products (particularly ICH E2A, E2C and E2B).Strong planning, organization, written and oral communication skills.Demonstrated skills and experience in:Safety Systems -administration, gateway support, data collection, report generation.Argus Safety DatabaseArgus Safety configuration managementImplementing, validating, and upgrading safety applications like Argus Safety, Empirica Signal, Axway, and Drug Safety Triager.Signaling tools (e.g. Empirica, Spotfire)Regulatory Inspection readinessDeveloping/implementing data displays (Dashboards) of data for signaling, compliance and departmental KPI's & QPI'sRelational database technology and query (SQL) development

Keywords: Green Key Resources, Somerville , Senior Manager, Safety Systems and Data Analytics, Executive , Somerville, Massachusetts