ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Supports the PMS process through:
* Development and maintenance of data systems & sources utilized for the performance of Post Market Surveillance activities
* Working cross-functionally with multiple departments to ensure data integrity and alignment globally
* Serving as the key point of contact with internal IT & Master Data Management teams
* Organization and management of PMS documentation
* Drive forward PMS data management process improvements
* Prepares data, tables and graphs for PMS Reports, PMS Trend Reviews and Management Reviews and supports other PMS team members with any other activities of report preparation as required.
* Supports requests for PMS data from Competent/Regulatory Authorities and Notified Bodies.
* Ensures compliance with all appropriate laws and regulations, relevant to the job function. Supports the implementation of policies and procedures to ensure compliance with appropriate statutes and regulations.
* Assists/participates in external and internal audits and in general quality system tasks
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE:
Bachelor's level degree in Computer Science, Engineering, or Science related disciple required. Advanced degree in same disciplines preferred.
Minimum 5 years of experience in roles focused on data management, data science, Excel, Access, SAP, and/or industry standard database tools. Experience within the medical device industry is preferred.
Equivalent years of graduate level education is acceptable in lieu of work experience.
Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures and government regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, customers and the general public.
Ability to apply advanced mathematical concepts, such as probability and statistical inference. Ability to apply mathematical operations to such tasks as frequency distribution, reliability, analysis of variance, correlation techniques, sampling theory and factor analysis. Strong computer skills are a must.
Ability to define problems, collect data, establish facts and draw valid conclusions. Ability to interpret an extensive variety of instructions furnished in written, oral, diagram or schedule form.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The Post Market Surveillance Specialist will spend approximately 80% of their working at a
computer keyboard. The Post Market Surveillance Specialist may spend up to 20% of his time walking or standing. The Post Market Surveillance Specialist must be able to speak and hear well enough to communicate effectively.
The Post Market Surveillance Specialist will not typically be exposed to a harsh or dangerous environment. The noise level will be quiet to moderate.
Associated topics: data architect, data center, data manager, data management, data quality, data scientist, database, etl, sql, teradata