Description :
Job Title PSUR Coordinator
External Job Description This position is responsible for the compilation of data for Periodic Reports. These reports are submitted at various times, dependent on local regulations. Assists in preparation for the creation of these reports includes participation in data collection and database searching.
1. Package the data for use in upcoming reviews and distribution.
2. Create submission cover letter.
3. Prepare MedWatch reports for regulatory submission.
4. Maintenance and distribution of affiliate contact table. Update and maintain Hospira Offline Matrix. Provide support that will help facilitate local regulatory reporting by Hospira.
5. Accurate and timely data entry of information into tracking tools. Follow up as appropriate to obtain sufficient data. Distribute documents/reports for review, sign-off and archiving. Actual mailing of documents to the regulatory authorities and associated task. Records electronic and hard copy information. Assist in special projects as assigned.
Skills/Experience Education/Certification Associates Degree preferred.
Knowledge of adverse event case processing, some medical terminology preferred, industry or regulatory environment beneficial, proficient typing skill, computer literacy, Microsoft 2000 applications experience required. Good written and oral communication skills required. Strong multitasking and organizational skills. Requires meeting multiple deadline demands.
Must work well with others. Dedicated to meeting expectations and requirements. Strong attention to detail and accuracy is a must.
State WI
Site Lake County IL
Location/Building HW1 (Pleasant Prairie)
Job Family Quality Assurance & Reg. Affairs
Job Category Full Time
Shift First
Start Time 8:15
Stop Time 4:55
Auto req ID 5085BR
