Quality Assurance R&D Pharmacovigilance Specialist

The primary objective of this function is to assure the development, implementation, and maintenance of Recordati's Quality Management System in relation to Pharmacovigilance, in alignment with Group and R&D quality standards. The role involves interaction with pharmacovigilance personnel at Headquarters, the PV contact person at each SPC Affiliate, and RRD PV personnel as required.

Requirements

• Management of Quality Assurance activities to assure the compliance with Good Pharmacovigilance Practice and Pharmacovigilance applicable regulation
• Management of SOPs/WIs on PV processes
• Pharmacovigilance Audits management
• QA Revision/approval of Deviations, CAPA, Change on PV topics
• Contribute of Training on GVP/Quality topics
• Contribute to Pharmacovigilance System Master File updates and review
• Contribute to Quality Management system periodic review
• Collaborate to budget preparation and revision for PV activities and invoice verification
• Quality oversight and support of the Pharmacovigilance teams with regard GVP
• Coordinate the activities of Local PV QA
• Active interaction and support within Group R&D QA
• Preparation of Group R&D SOPs/WIs on QA PV processes
• Revision of SOPs/WIs issued Recordati Departments/Affiliates
• Collaborate with QA R&D Document Management and Affiliates QA for the revision and update of SOPs/WIs Matrix
• HQ PV system, Affiliates, Service Providers, Business Partners Audit management
• Manage/oversight /coordinate Affiliates’ PV audits
• HQ and Affiliates Risk assessment management for audit prioritization (Affiliate, Partners, Service Providers, PV System
• Strategic and Annual PV Audit Programme management
• Ensure HQ and Affiliates inspection readiness
• Revision /approval of HQ and Affiliates Audit Plan/Report, Deviations, Audit/Inspection CAPA, Change controls on PV topics