Senior Associate Operational Excellence & Compliance

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