Quality Assurance R&D Pharmacovigilance Specialist

4 settimane fa

Milano, Lombardia, Italia Experteer Italy A tempo pieno
Job Purpose

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. Responsibilities include coordinating the activities of Affiliates' QA R&D for Pharmacovigilance and liaising with local QA teams. Additionally, the resource will manage the activities of its reporting personnel at RRD Sarl - Group QA R&D – PV RRD. The resource will report directly to the Group R&D – R&D QA Manager.

Key Responsibilities

Management of Quality Assurance activities to assure 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 to Training on GVP/Quality topics. Contribute to Pharmacovigilance System Master File updates and review. Contribute to Quality Management system periodic review. Collaborate on budget preparation and revision for PV activities and invoice verification. Quality oversight and support of the Pharmacovigilance teams regarding 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 by 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. Required Education

Life science or other relevant qualifications. Required Skills and Experience

• 6-8 years experience in the same role in Pharmaceutical companies and/or PV CROs.
• Project Management.
• Microsoft Word, Excel, PowerPoint, Teams, and Outlook.
• Software knowledge (e.g., eDMS).
• Computer System Validation knowledge.
• Knowledge of QA Standards.
• Ability to propose solutions, take decisions and/or refer to manager.
• Ability to work across cultures.
• Flexible and adaptable.
• Initiatives and self-motivation capacities.
• Positive thinking and enthusiasm.
• Ability to travel on a periodical basis.
• Strict on confidentiality, rules, procedures, and timelines.
• Positive attitude and ability to interact and communicate diplomatically and professionally with internal and external customers in a global environment.
• Excellent organization skills and ability to handle multiple competing priorities within tight timelines.
• Management / Leadership skills. Required Languages

Fluent in English (spoken and written).

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