Medical Device Safety Data Analyst -Whippany, NJ

 

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Medical Device Safety Data Analyst -Whippany, NJ 

 

Medical Device Safety Data Analyst - Whippany, NJ

PURPOSE

The purpose of the Medical Device Safety Data Analyst position is to conduct the primary, recurrent and further analyses to generate the data essential to provide the answers to medical questions and regulatory requirements. You will work closely with Global Safety Leaders (GSLs) and Medical Device Safety (MDS) within the PV Benefit Risk Management (BRM) department, who will rely on the data output generated by you. In addition, you will advise on matters relating to data processing and the advanced use of analytical tools. This is to be seen as a key element for the ongoing upskilling of BRM to utilize new analytical tools. This requires close collaboration between the BRM and PV Analytics units, which, in turn, will lead to increased exchange of information both within and between the working groups.

 

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role are to:

Conduct the primary, recurrent and further analyses to generate data from the ARGUS PV database relating to reports and documents to be sent to the regulatory authorities (e.g. PBRER, DSUR,RMP), subject-specific inquiries from authorities, interaction between internal medical committees (e.g. the Global Safety Committee) and internal documents for approved products (e.g. Company Core Data Sheet), signal detection and signal management matters, activities relating to the weekly or product-specific ongoing monitoring and any data from clinical settings or other data sources, with emphasis on adverse event reporting databases.

• Strategize and align with BRM in developing data analysis strategies and in generating outputs using suitable PV database retrieval strategies;
• Independently ordering and creating the required output formats;
• Independently generate data and analyses by creating overviews, summaries, preliminary selections, and criteria searches;
• Format and edit data in line with the required conditions (sorting, filtering, flagging);
• Perform calculations relating to frequencies, exposures, and reporting rates;
• In alignment with the GSL or MDS, create, update, and adjust work templates/workbooks (e.g., in Spotfire) or Excel outputs for recurrent analyses for ongoing monitoring or aggregated reports;
• Create visualizations in the form of graphics and tables for regulatory reporting, internal safety updates, signal evaluations and other analysis purposes and product-specific matters;
• Generate the data including descriptive statistics, trend analysis, outliers, and correlations, and provide a preliminary assessment of relevant data, as well as reviews of prior data and relevant comparisons;
• Advise the GSLs on database content by knowing data entry rules and policies and recommending suitable presentation formats;
• Advise senior management in the BRM organization on the use of tools, structure of queries (e.g., in accordance with MedDRA criteria, WHO Drug) and the best presentation formats for results data;
• Act as advanced trainer to BRM on analytical tool use, database content and query strategies, as well as providing deep content expertise in creating enduring training materials;
• Establish and maintain libraries of items of interest linked to the database for output harmonization;
• Develop standardized solutions for recurring data analysis tasks across BRM groups;
• Responsible for the technical onboarding and initial training for new colleagues on the PV BRM workflows by demonstrating important programs and tools, helping with software and system access and other tool-related and process-oriented procedures;
• Contributing to problem solving in BRM processes by interfacing with PV Analytics, PV Single Case Processing, and any other PV roles;
• Promoting cross-group standardization of processes for activities within the therapeutic BRM groups. Holding structured information exchange sessions on specific topics to improve quality assurance;
• The partnership between the BRM-DA and BRM will further improve the speed and quality of data outputs from PV databases, their interpretation, documentation, and communication. The BRM o