Principal Duties
• Collaborates with internal departments on implementation of quality principles and regulatory requirements related to Good Pharmacovigilance Practice (GVP)
• Coordinates PV-related aspects of inspection readiness activities
• Assists and other departments in addressing audit findings and development of Corrective and Preventative Actions (CAPAs)
• Participates in development and reporting of compliance metrics related to GVP activities
• Conducts effectiveness checks and internal assessments of current processes and procedures to identify potential process improvement opportunities
• Assist in hosting of regulatory inspections related to PV
• Applies departmental SOPs and participates in the development of departmental SOPs, as appropriate
• Responsible for maintenance, update, and change control of the Pharmacovigilance System Master File (PSMF)
• Monitors commitments from internal audit and regulatory inspection findings
• Performs late case investigations and writes delayed case reports