Specialist, Pharmacovigilance
Core
Execute day-to-day operations and compliance activities to maintain high-functioning Pharmacovigilance (PV) systems across assigned region remit.
Role type
Specialist, Pharmacovigilance
Builds
PV systems and compliance frameworks
Domain
Pharmaceutical industry, Pharmacovigilance
Deliverable
infrastructure
Required skills
Develop and maintain local/regional procedures, Perform impact assessment of new/updated corporate policies, Assist with PV Exception Reporting and CAPA process, Support business continuity plan and testing, Support regional ICSR management, Manage internal PV audits and Regulatory Authority inspections, Develop CAPA in response to observations, Ensure PV requirements for safety information handling, Ensure overall training compliance, Maintain PV Training Matrix
Preferred skills
Experience in disease management in a patient/health related field
Technologies
Microsoft Word, PowerPoint, Excel
Responsibilities
Develops and maintains local/regional procedures in line with corporate procedures and local requirements; Performs the impact assessment of new/updated corporate policies, process, and procedures; Actively assists with the local PV Exception Reporting/ corrective and preventive actions (CAPA) process; Supports the provision of metrics that will ensure oversight of all aspects of the performance and functioning of the PV system; Supports regional ICSR management as needed; Actively assists in managing internal PV audits, audits of affiliate service providers/third parties and Regulatory Authority PV Inspections; Ensures all PV requirements are in place for activities where there is a reasonable possibility for the identification and/or handling of safety information; Ensures overall training compliance with corporate procedures and local PV requirements.
Seniority
Specialist, operational execution