Pharmacovigilance Regulatory & Compliance Officer

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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