Pharmacovigilance Regulatory

The Pharmacovigilance Regulatory & Compliance Officer is mainly responsible for :

Contributing to maintain or improve quality performance and compliance of operational PV activities  Ensuring Deviation and CAPA Management, Document Control, and other Quality Management System activities.  Developing, managing, and executing quality management processes to ensure quality standards are maintained and compliant with regulatory requirements. Coordinating PV audits and Inspections

Specific Activities & Responsibilities :

Investigating and documenting late ICSR, Aggregate Report, ESI and any other submission required to regulatory bodies, monitoring the timely exchange of ICSRs with Business Partners. Generation, quality review, and distribution of compliance and quality metrics and trending activities. Coordinating compliance, quality, and process improvement initiatives while providing input into corrective/preventative actions and effectiveness measures for Corrective and Preventative Action plans (CAPA), as appropriate. She/he contributes in monitoring and escalate compliance issues related to global PV obligations to senior management. Contributing in the Identification of potential quality failures and establish appropriate corrective actions including coordination of their implementation. Management of the Quality document planning  Serving as Subject Matter Expert (SME) for Operational Managers in investigating and Deviations, Quality Events, identifying CAPAs. Ensuring the third parties (Business partners and vendors) qualifications and its documentation. Coordinating collection of information as requested in risk analysis questionnaire from Business Partners and Regulatory Authorities. Coordinating audits and regulatory inspections by engaging with auditor/inspector in agenda finalization, document provision; ensuring internal logistics and SMEs are in place; host and facilitate the audit/inspection; coordination and management of audit CAPA responses; and finally ensuring audit information is maintained and stored in the dedicated tool. Supporting internal audit activities, throughput coordination and management of CAPA responses, which requires close collaboration with management. Liaising and communicating with all applicable internal and external stakeholders on all aspects of Quality responsibilities in a professional and business focused manner to ensure good relations between the Quality, and other internal team members.  Contributing on the PV Quality Review Process (Quality controlled document management, CAPA closure, deviation, KPI, change control… Contributing in monitoring vendors quality in liaison with the operational team. When monitoring compliance, she/he Investigates and documents scores below quality thresholds. Opens Quality Investigations when trend is identified Works with key stakeholders to ensure robust corrective/preventative and effectiveness checks are implemented Generating, reviewing, and distributing compliance and quality metrics for the oversight of the Quality Management System. Collaborating with key stakeholders to ensure metrics meet oversight needs Developing, reviewing, implementing, and/or validating new metrics presentations, visualizations, and reports Ensuring the performance of the Business continuity tests.

General responsabilitiies

Create and maintain quality documents related to her/his scope of activities and she/he ensures that those quality documents are in line with the regulatory requirements Periodically report on her/his activities to the direct line manager Identify potential risks in terms of activities under her/his scope and informs immediately her/his direct line manager Contribute to preparing and monitoring inspections and audits by business partners on a Global Safety departmental level and at the affiliate level.

Profile 

Pharmacist, Scientist At least 5 years of experience within the pharmaceutical industry in the PV field including 3 years in PV quality and analysis of data. Excellent knowledge of regulatory requirements at the worldwide level. Project Management experience with organizing actions and managing team activities. Experience developing and conducting presentations for different levels of management with the ability to tailor presentations to the appropriate level of detail. Fluency in English. Good IT experience: pack office and internal tool

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