非公開
SUMMARY:
Responsible for the collection, processing, evaluation and reporting of incoming
Serious Adverse Event (SAE) data according to applicable regulatory
guidelines/requirements, Worldwide Standard Operating Procedures (SOPs) and project
specific instructions.
Serves as Lead PV Associate on small to moderate sized studies that are simple to moderate
in complexity and scope of work with support from senior staff.
RESPONSIBILITIES:
Tasks may include but are not limited to:
With guidance and oversight:
Author Safety Management Plan for assigned studies
Attend internal and client meetings as appropriate
Attend and present at Investigator Meetings
Review incoming SAE data for completeness and accuracy
Perform data entry in the Safety Database and/or complete applicable tracking of
incoming safety information
Generate queries for missing or unclear information and follow-up with sites for
resolution
Perform QC of SAEs processed by other PV Associates
Generate regulatory reports and perform safety submissions as needed
Prepare and submit periodic safety reports as needed
Maintain knowledge and understanding of safety related regulations and guidelines
Maintain basic understanding of budget and scope of work for assigned projects,
ensuring compliance and escalation of any potential changes in scope
May assist with bid defenses or other presentations
May mentor or train new PV staff
Perform other duties as assigned
フルリモートが可能なグローバルCROです