• Pharmacovigilance (PV) Quality Assurance System Governance.
• Maintaining oversight of the quality systems within Pharmacovigilance department.
• Review &/or Approval of Quality system documents related to Pharmacovigilance.
• Ensure compliance with written procedures/policy/manuals.
• Ensure all time readiness of Pharmacovigilance function for client audits/visits and regulatory inspections.
• Handling of External Audits, Regulatory Inspections, & client visits related to Pharmacovigilance function.
• Monitor the deficiencies and deviations within PVD and shall ensure compliance and implementation of Corrective and Preventive Actions (CAPA) in accordance with relevant QMS SOP.
• On-boarding & training of new joinee within PVD – Compliance with defined requirements and completeness of Individual training plans, on-job trainings, Job Responsibilities etc
• Perform quality review of PV activities to monitor the PV process on regular basis.
• Conducting or Assisting in QMS Audits, Vendor Qualification Audits, For Cause Audits and Pre-Inspection Audits for PV function of Pharmazone.
• Addressing external queries pertaining to quality and compliance of PV.
• Distribution of documents to the PV personnel after coordinating with Quality Management System department.
• Any other responsibilities assigned by management time to time.