Data Analyst - REMS Compliance

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Position Summary

REMS Compliance is responsible for defining, developing, and executing the REMS noncompliance and audit programs, including tracking data and metrics when FDA requires a Risk Evaluation and Mitigation Strategy (REMS) that includes auditing the legal entities providing therapy to patients. REMS Compliance collaborates with Local Market Patient Safety (LMPS) and relevant functions to provide global tracking and oversight of Risk Minimization Programs (RMinP) 3rd Party nonadherence events.

• Subject Matter Expert (SME) for all aspects of REMS and RMinP 3rd party noncompliance and nonadherence data analytics.

• Contributes to the development, implementation, use and improvement of electronic tools used to perform noncompliance, nonadherence, and surveillance activities. Leverages automation and electronic capabilities to streamline processes and enhance operational excellence.  Appropriately increases/enhances electronic enablement.

• Drives continuous process improvement and efficiency by leveraging existing and emerging technology solutions through collaboration with WWPS and IT functions. Contributes to special projects.

• Adopts the BMS Quality Management System (QMS) within the team’s scope and identifies opportunities for 1) increasing operational excellence, 2) continuous improvement, and 3) progressing the maturity model of the BMS QMS.

Duties/Responsibilities

• REMS Compliance electronic system Super User and SME.

• Contributes to validation projects and system testing. Interface with the IT Delivery Team(s).

• Responsible for downloading, visualizing, organizing, and verifying data: 1) required for Health Authority inspections and submissions (such as REMS Assessment Reports and Information Requests), 2) supporting REMS audit and noncompliance programs, 3) supporting RMinP 3rd Party nonadherence programs, and 4) needed to facilitate management oversight.

• Monitors and triages incoming messages to the REMS Compliance and RMinP Compliance shared mailboxes. 

• Responsible for timely (usually same day) responses to requests affecting external REMS participants, such as creating/disabling/updating pharmacy staff profiles in REMS systems, handling password re-sets, managing/improving automated reports, and resolving or escalating systems issues.

• Adopts the BMS QMS by leading the development and implementation of written procedures for data-centric processes, such as preparing and validating data tables, developing yearly audit plan that require risk-ranking sites, etc.

Qualifications

• A minimum of 5 years’ experience using data analysis tools such as Excel, pivot tables, Tableau and/or SpotFire.

• Experience with electronically enabled processes in a regulated environment a plus.

• Experience working with and analyzing large data sets to identify inconsistencies and errors.

• Proven ability to support decision-making by distilling and communicating quantitative information.

• Advocates and propagates the highest standards of quality and compliance.

• Strong time-management, organizational, and problem-solving capabilities. Ability to work independently and to define and set targets for completion of tasks, both as an individual and within a team.

• Demonstrated ability to work in a complex, changing environment and accountable for actions and results.

• Delivers on assign tasks with high standards, high productivity and meeting established standard