Principal DutiesĀ
⢠Collaborates with internal departments on implementation of quality principles and regulatory requirements related to Good Pharmacovigilance Practice (GVP)Ā
⢠Coordinates PV-related aspects of inspection readiness activities
⢠Assists and other departments in addressing audit findings and development of Corrective and Preventative Actions (CAPAs)Ā
⢠Participates in development and reporting of compliance metrics related to GVP activitiesĀ
⢠Conducts effectiveness checks and internal assessments of current processes and procedures to identify potential process improvement opportunitiesĀ
⢠Assist in hosting of regulatory inspections related to PVĀ
⢠Applies departmental SOPs and participates in the development of departmental SOPs, as appropriateĀ
⢠Responsible for maintenance, update, and change control of the Pharmacovigilance System Master File (PSMF)Ā
⢠Monitors commitments from internal audit and regulatory inspection findingsĀ
⢠Performs late case investigations and writes delayed case reports
Integrated Resources INC
https://careers.smartrecruiters.com/IntegratedResourcesINC