Job Description
Ensure compliance with local and global PV regulations
Collect, assess, and report ICSRs in a timely and accurate manner
Prepare and review global and local PV documents
Conduct and oversee literature screening for safety information
Support signal detection and escalate safety concerns to global teams
Maintain and update PV system, SOPs, safety agreements, and compliance records
Deliver PV training on adverse event (AE) and Product quality complaint (PQC) Reporting
Ensure inspection readiness and support audits and regulatory inspections
Collaborate with global PV teams and local stakeholders to align local practices with international standardsEnsure compliance with local and global PV regulations
Collect, assess, and report ICSRs in a timely and accurate manner
Prepare and review global and local PV documents
Conduct and oversee literature screening for safety information
Support signal detection and escalate safety concerns to global teams
Maintain and update PV system, SOPs, safety agreements, and compliance records
Deliver PV training on adverse event (AE) and Product quality complaint (PQC) Reporting
Ensure inspection readiness and support audits and regulatory inspections
Collaborate with global PV teams and local stakeholders to align local practices with international standards