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.
Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required.
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 data entry
Medical terminology and coding
Regulatory reporting and compliance
Literature screening and review
xEVMPD product record validation
Nice-to-have
Fosters constructive working relationships
Passionate about developing people
Authentically be yourself culture
Key Requirements
Bachelor’s Degree in life science, RN, or pharmacist
Equivalent combination of education and experience