Descrizione dell'offerta
Job Title: EU - Qualified Person for Pharmacovigilance (QPPV)
Location: Italy Remote
Reports to: Global Head of Medical Safety and Pharmacovigilance
The Opportunity
Menarini Stemline is searching for an experienced Qualified Person for Pharmacovigilance (QPPV) who thrives on high-level safety oversight and shares a genuine passion for science and making a meaningful difference in patients' lives. This is a high-visibility role with a significant level of responsibility, offering the unique chance to fulfill the regulatory obligations for both the European Union (EU) and the United Kingdom (UK). In this position, you will ensure the robust maintenance of our Pharmacovigilance (PV) systems, oversee the benefit/risk profile of Stemline’s authorized products, and provide strategic leadership to our cross-functional teams and local PV representatives globally.
Responsibilities
Pharmacovigilance System Oversight
- Ensure the implementation, maintenance, and continuous improvement of a compliant EU and UK Pharmacovigilance system. - Maintain oversight of key PV processes including: - PV System Master File (PSMF) - Standard Operating Procedures (SOPs) - Signal management - Compliance metrics and KPIs - Training programmes - Vendor and partnership oversight - Review PV audit schedules and oversee the implementation of corrective and preventive actions (CAPAs). - Ensure timely and compliant submission of pharmacovigilance documentation to regulatory authorities including EMA, MHRA, and EU Competent Authorities. - Participate in compliance-related governance and decision-making forums.
Benefit-Risk Management
- Maintain oversight of the benefit-risk profile of authorised Stemline products. - Review and approve Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), and Post-Authorisation Safety Studies (PASSs). - Lead pharmacovigilance activities related to emerging safety concerns and risk minimisation measures. - Support regulatory actions associated with safety-related updates, variations, and communications.
Regulatory Authority Engagement
- Act as the primary contact for Pharmacovigilance inspections and regulatory interactions within the EU and UK. - Serve as the 24/7 contact point for applicable regulatory authorities. - Ensure timely and complete responses to health authority requests relating to product safety and benefit-risk assessment. - Monitor and interpret evolving pharmacovigilance regulations and assess their impact on the organisation.
Leadership & Cross-Functional Collaboration
- Partner closely with Regulatory Affairs, Medical Affairs, Quality Assurance, Clinical Development, and other internal stakeholders. - Promote a strong culture of compliance and patient safety throughout the organisation. - Provide guidance and oversight to local Pharmacovigilance representatives. - Support the development of pharmacovigilance capabilities across the organisation.
Background & Experience
- Qualified Healthcare Professional with significant experience in Pharmacovigilance, Drug Safety, or related disciplines. - Minimum of 12 years' relevant industry experience. - Extensive knowledge of EU and UK Pharmacovigilance regulations and requirements. - Demonstrated experience managing Pharmacovigilance systems within a regulated environment. - Strong understanding of benefit-risk management, signal detection, risk management activities, and post-marketing safety obligations. - Experience interacting with health authorities and supporting inspections and audits. - Proven ability to work effectively across complex, global organisations and influence cross-functional stakeholders. - Business-fluent English with excellent written and verbal communication skills is essential.
The selected candidate will be employed under Category "A" in accordance with the provisions of the current National Collective Bargaining Agreement (CCNL) for the Chemical and Pharmaceutical Industry, including all applicable contractual and remuneration terms, and in compliance with Legislative Decree No. 96/2026.
Menarini Stemline is an equal-opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees
Location: Italy Remote
Reports to: Global Head of Medical Safety and Pharmacovigilance
The Opportunity
Menarini Stemline is searching for an experienced Qualified Person for Pharmacovigilance (QPPV) who thrives on high-level safety oversight and shares a genuine passion for science and making a meaningful difference in patients' lives. This is a high-visibility role with a significant level of responsibility, offering the unique chance to fulfill the regulatory obligations for both the European Union (EU) and the United Kingdom (UK). In this position, you will ensure the robust maintenance of our Pharmacovigilance (PV) systems, oversee the benefit/risk profile of Stemline’s authorized products, and provide strategic leadership to our cross-functional teams and local PV representatives globally.
Responsibilities
Pharmacovigilance System Oversight
- Ensure the implementation, maintenance, and continuous improvement of a compliant EU and UK Pharmacovigilance system. - Maintain oversight of key PV processes including: - PV System Master File (PSMF) - Standard Operating Procedures (SOPs) - Signal management - Compliance metrics and KPIs - Training programmes - Vendor and partnership oversight - Review PV audit schedules and oversee the implementation of corrective and preventive actions (CAPAs). - Ensure timely and compliant submission of pharmacovigilance documentation to regulatory authorities including EMA, MHRA, and EU Competent Authorities. - Participate in compliance-related governance and decision-making forums.
Benefit-Risk Management
- Maintain oversight of the benefit-risk profile of authorised Stemline products. - Review and approve Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), and Post-Authorisation Safety Studies (PASSs). - Lead pharmacovigilance activities related to emerging safety concerns and risk minimisation measures. - Support regulatory actions associated with safety-related updates, variations, and communications.
Regulatory Authority Engagement
- Act as the primary contact for Pharmacovigilance inspections and regulatory interactions within the EU and UK. - Serve as the 24/7 contact point for applicable regulatory authorities. - Ensure timely and complete responses to health authority requests relating to product safety and benefit-risk assessment. - Monitor and interpret evolving pharmacovigilance regulations and assess their impact on the organisation.
Leadership & Cross-Functional Collaboration
- Partner closely with Regulatory Affairs, Medical Affairs, Quality Assurance, Clinical Development, and other internal stakeholders. - Promote a strong culture of compliance and patient safety throughout the organisation. - Provide guidance and oversight to local Pharmacovigilance representatives. - Support the development of pharmacovigilance capabilities across the organisation.
Background & Experience
- Qualified Healthcare Professional with significant experience in Pharmacovigilance, Drug Safety, or related disciplines. - Minimum of 12 years' relevant industry experience. - Extensive knowledge of EU and UK Pharmacovigilance regulations and requirements. - Demonstrated experience managing Pharmacovigilance systems within a regulated environment. - Strong understanding of benefit-risk management, signal detection, risk management activities, and post-marketing safety obligations. - Experience interacting with health authorities and supporting inspections and audits. - Proven ability to work effectively across complex, global organisations and influence cross-functional stakeholders. - Business-fluent English with excellent written and verbal communication skills is essential.
The selected candidate will be employed under Category "A" in accordance with the provisions of the current National Collective Bargaining Agreement (CCNL) for the Chemical and Pharmaceutical Industry, including all applicable contractual and remuneration terms, and in compliance with Legislative Decree No. 96/2026.
Menarini Stemline is an equal-opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees
Candidatura e Ritorno (in fondo)
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