This position will ensure medical safety data review and evaluation in accordance with post-market and pre-market regulatory requirements. Communicates potential and known risks, when appropriate, to Management, Quality Assurance, Regulatory Affairs, and Clinical Affairs personnel. Conduct clinical trial safety and commercial safety activities.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively in front of the groups of customers or employees of organization.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
Ability to apply common sense understanding to carry out detailed written or oral instructions. Works on assignments that are moderately complex in nature where judgment is required in resolving problems and making routine recommendations.
Basic computer skills are required.
Certificates and Licenses:
No certifications needed
This job has no supervisory responsibilities.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
The noise level in the work environment is usually moderate. The duties may require working in a Controlled Environment Room (CER).
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.
While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel and reach with hands and arms. The employee is frequently required to walk and sit.