Performing submissions of ICSRs/aggregate reports to all concerned parties. Active participation in trainings, maintenance and development of quality system documents for Safety Reporting area.
Numbers & Facts
Location
Raleigh, NC
Description
Job Description
Supporting the client in all aspects of safety submission
Supports the Submission Manager in development, documentation, implementation and maintenance of submission processes and standards
Ensures personal knowledge and understanding of global regulatory reporting requirements to ensure compliance
Performing submissions of ICSRs/aggregate reports to all concerned parties
Performing exchanges of ICSRs with all concerned parties as per applicable documents
Providing support in all PV operations associated with Safety Reporting
Performing Quality control of ICSR Reportability Assessment
Performing Quality control of daily safety submission activities
Active participation in trainings, maintenance and development of quality system documents for Safety Reporting area
Provide training for junior members of the team
Acts as an SME for Submissions in audits and inspections representing Submissions business processes and standards