Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required
Job Summary
Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required.
Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process.
Matching Summary
Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required.
Skills & Requirements
Must-have
PVG quality and tracking systems
ICSR processing and reporting
Safety database entry and coding
Literature screening and review
xEVMPD product record validation
SPOR / IDMP activities
Quality review of ICSRs
TMF and PV System Master File maintenance
Nice-to-have
Fosters constructive working relationships
Participates in audits
Applies safety reporting regulatory intelligence
Key Requirements
Bachelor’s Degree in life science, registered nurse, pharmacist or equivalent