Corporate Head Of Pharmacovigilance & Qppv

WE ARE HIRING!

CORPORATE HEAD OF PHARMACOVIGILANCE & QPPV

Neuraxpharm is looking for people who want to make a difference and improve patients’ lives within the CNS area. We want individuals who will go the extra mile and make great things happen.

Being part of this team does not mean you are just working for a company, but for a cause!

Neuraxpharm is looking for a Corporate Head of Pharmacovigilance & QPPV based in Barcelona (hybrid role)

Your mission:

The Corporate Head of Pharmacovigilance and EU/UK QPPV is accountable for the strategic leadership, governance, maintenance and continuous improvement of the Neuraxpharm Pharmacovigilance System, ensuring that it remains effective, compliant and inspection-ready across all territories in which Neuraxpharm holds marketing authorizations.

The role leads the Corporate Pharmacovigilance function and provides oversight of pharmacovigilance activities performed by affiliates, partners and external service providers, ensuring that significant safety, compliance, quality, operational and resourcing risks are identified, assessed, escalated and appropriately managed.

The role ensures appropriate integration of new affiliates, products, territories, acquisitions, divestments and licensing arrangements into the pharmacovigilance system through documented, risk-based transition and implementation plans.

As EU and UK QPPV, the role fulfils the applicable legal and regulatory responsibilities and has sufficient authority, organizational independence, access to relevant information and direct access to Senior Management to influence the pharmacovigilance system, its quality system and the allocation of adequate resources.

Your major accountabilities:

• Lead, develop and ensure appropriate resourcing and competencies of the Corporate Pharmacovigilance team.
• Maintain and continuously improve the Neuraxpharm Pharmacovigilance System and its quality system, including integration of new affiliates and compliance with applicable global and local requirements.
• Maintain oversight of the safety profiles and benefit-risk balance of medicinal products for which Neuraxpharm holds marketing authorizations, ensuring timely escalation and management of emerging safety issues and validated signals.
• Establish and maintain a risk-based governance and oversight framework for pharmacovigilance activities performed by affiliates, partners and external service providers, including compliance metrics, quality issues, deviations, CAPAs, audits and periodic governance reviews.
• Ensure effective exchange of safety and compliance information across Neuraxpharm functions, affiliates, partners and pharmacovigilance service providers.
• Ensure appropriate pharmacovigilance training and awareness across the Neuraxpharm Group and verify its effectiveness through the pharmacovigilance quality system.
• Ensure continuous inspection readiness and provide leadership for regulatory inspections and significant partner audits, including response strategy, CAPA governance and effectiveness verification.
• As EU and UK QPPV, fulfil the applicable legal and regulatory responsibilities and ensure permanent and continuous availability through documented deputy, escalation and business continuity arrangements.
• Provide QPPV oversight and, where applicable, review or approve signal management outputs, aggregate safety reports, risk management plans, additional risk minimisation measures and responses to competent authorities.
• Ensure that emerging safety issues, validated signals, significant changes to the benefit-risk balance and urgent safety restrictions are promptly evaluated, escalated, documented and appropriately managed.
• Ensure that the Pharmacovigilance System Master File and its summary accurately and reliably describe the Neuraxpharm Pharmacovigilance System and are maintained in an inspection-ready state.
• Maintain oversight of individual case safety report management, literature monitoring, product data, safety data exchange agreements, regulatory submissions and other critical pharmacovigilance processes.
• Ensure that pharmacovigilance agreements clearly define responsibilities, timelines, safety-data exchange and oversight arrangements, and that relevant changes are implemented in a controlled manner.
• Establish and maintain a risk-based governance model for external pharmacovigilance service providers, including performance indicators, compliance metrics, quality issues, deviations, CAPAs, audit outcomes, service risks and periodic governance reviews.
• Ensure that outsourcing does not compromise the MAH accountability, QPPV authority or timely QPPV access to relevant safety, quality and compliance information.
• Ensure continuous pharmacovigilance inspection readiness and lead the pharmacovigilance response to regulatory inspections and significant partner audits, including preparation, coordination, response strategy, CAPA governance and effectiveness verification.
• Ensure that significant and critical pharmacovigilance compliance issues are subject to timely escalation, documented root-cause analysis, appropriate corrective and preventive actions and effectiveness checks.
• Maintain a risk-based pharmacovigilance audit strategy and programme in collaboration with Quality Assurance, and ensure appropriate follow-up of audit findings.
• Ensure appropriate governance of reference safety information and timely implementation and communication of safety-related variations in collaboration with Regulatory Affairs and other relevant functions.
• Assess the pharmacovigilance impact of acquisitions, divestments, licensing agreements, portfolio transfers, new products, new territories, new affiliates and changes to the operating model, and ensure appropriate transition plans.
• Define and periodically assess the resources, capabilities and competencies required to operate an effective and compliant pharmacovigilance system, escalating material gaps to Senior Management.
• Ensure business continuity and disaster recovery arrangements are established, documented and periodically evaluated for critical pharmacovigilance processes and systems.
• Ensure appropriate governance, data integrity, validation and regulatory compliance of pharmacovigilance systems and digital solutions, including controlled use of automation and artificial intelligence with appropriate human oversight and risk management.Chair or provide pharmacovigilance leadership to applicable safety governance forums and ensure that safety decisions, accountabilities and follow-up actions are documented

We would like you to have:

• Minimum 10 years of progressive experience in pharmacovigilance within the pharmaceutical industry and/or a pharmacovigilance service provider, including significant experience in global PV operations, quality systems, regulatory inspections and outsourced-service oversight.
• Demonstrated experience leading a pharmacovigilance function or multidisciplinary PV team, including people development, resource planning and senior-management escalation.
• Previous experience acting as EU/EEA QPPV, UK QPPV or Deputy QPPV is strongly required.
• Experience in benefit-risk governance, partner and affiliate oversight, due diligence, integration and pharmacovigilance transitions is desirable.
• Expert knowledge of applicable EU, UK and relevant international pharmacovigilance legislation, GVP and associated regulatory guidance.
• Strong knowledge of pharmacovigilance quality systems, audits, inspections, deviations, CAPAs and inspection readiness.
• Working knowledge of data protection, records management, data integrity and validated pharmacovigilance systems.
• Strong digital literacy and experience governing pharmacovigilance systems, data and technology-enabled processes.
• Life Science degree in Medicine, Pharmacy or another relevant Life Sciences discipline.
• Documented adequate theoretical and practical knowledge for the performance of EU and UK QPPV responsibilities.
• Demonstrated knowledge of benefit-risk evaluation and relevant areas including medicine, pharmaceutical sciences, pharmacoepidemiology and biostatistics.
• Relevant professional training or certification in pharmacovigilance systems, EudraVigilance, MedDRA or benefit-risk evaluation would be an advantage
• Mobility: 20-30%
• Language: Fluent English