In sintesi
- Mansioni: Gestisci il sistema di farmacovigilanza globale e le alleanze strategiche per garantire la sicurezza dei pazienti.
- Azienda: Azienda innovativa nel settore farmaceutico con un forte focus sulla compliance e la qualità.
- Benefit: Retribuzione competitiva, opportunità di crescita professionale e ambiente di lavoro dinamico.
- Altre informazioni: Ambiente stimolante con opportunità di apprendimento continuo e sviluppo delle competenze.
- Perché questo lavoro: Fai la differenza nella sicurezza dei pazienti e collabora con team internazionali.
- Qualifiche: Laurea in farmacia o scienze della vita e almeno 3 anni di esperienza in farmacovigilanza.
La retribuzione prevista è compresa tra 70000 - 90000 € per anno.
Job description
Scope of the Role
The Global Pharmacovigilance System & Alliance Senior Manager plays a critical role in ensuring the effectiveness, compliance, and continuous maintenance of the Company’s Global Pharmacovigilance (PV) System.
Acting in close collaboration with the Global PV Governance Director and on behalf of the Qualified Person for Pharmacovigilance (QPPV), this position is responsible for overseeing key pharmacovigilance governance activities, maintaining compliance with global regulatory requirements, and supporting the management of strategic alliances and third-party partnerships.
The role ensures that pharmacovigilance processes, systems, agreements, and documentation remain compliant with applicable global regulations, internal procedures, and industry best practices, contributing to patient safety and regulatory excellence across all Company operations.
Your Role
- As Global Pharmacovigilance System & Alliance Senior Manager, you will:
- Coordinate, review, and maintain global Pharmacovigilance Agreements (PVAs) with Contract Service Organizations, distributors, licensees, and other business partners, including related delegation and termination letters.
- Support the Global PV Governance Director and QPPV in maintaining and continuously updating the Pharmacovigilance System Master File (PSMF).
- Plan, coordinate, and oversee global Pharmacovigilance training programs for employees, field force personnel, vendors, and affiliates.
- Review and approve local PV training materials to ensure consistency with global standards and regulatory requirements.
- Participate in and support internal and external Pharmacovigilance audits.
- Support Pharmacovigilance inspections conducted by Competent Authorities at a global level.
- Ensure the accurate maintenance and updating of the Company product list used for PV activities.
- Manage Global Regulatory Intelligence activities, including regulatory monitoring, gap assessments, and impact evaluations.
- Ensure timely execution of all assigned PV activities in accordance with current legislation, GVP requirements, internal SOPs, and working instructions.
- Draft, review, and update Global Pharmacovigilance SOPs and Working Instructions within the assigned area of responsibility.
- Oversee and maintain the Global Pharmacovigilance archive and ensure inspection readiness.
- Collaborate effectively with cross-functional stakeholders to drive compliance, operational excellence, and continuous improvement of the PV Quality System.
Who You Are
Education & Experience
- Degree in Pharmacy, Life Sciences, or a related scientific discipline.
- Minimum 3 years of experience in Pharmacovigilance activities associated with GVP Modules I and II, or at least 2 years of experience in GVP Quality Assurance.
- Solid experience working within global Pharmacovigilance and Quality Systems environments.
- Technical Expertise
- Strong knowledge of EU Good Pharmacovigilance Practices (GVP) and international Pharmacovigilance regulations.
- Good understanding of pharmacovigilance quality systems and governance processes.
- Strong knowledge of ISO 9001 principles and quality management systems.
- Experience in regulatory intelligence, compliance monitoring, and impact assessment activities.
- Proficiency in Microsoft Office applications.
- Professional working proficiency in English.
- Competencies & Skills
- Excellent communication, stakeholder management, and interpersonal skills.
- Strong negotiation capabilities, particularly in managing and negotiating Pharmacovigilance Agreements with external partners.
- Ability to prioritize effectively and manage multiple activities in a dynamic environment.
- Strong analytical thinking and sound decision-making skills.
- Continuous learning mindset with a strong interest in evolving global regulatory requirements.
- Proven ability to work collaboratively across cross-functional and international teams.
- High level of attention to detail, compliance focus, and commitment to quality and patient safety.
The compensation range indicated in this job posting represents an estimated average range for the position.
The final remuneration will be determined based on the selected candidate’s experience, skills, and qualifications, in accordance with applicable EU pay transparency and pay equity requirements
Sr. Manager, Global PV System Management & Alliance in Bologna datore di lavoro: Alfasigma
Alfasigma è un datore di lavoro eccezionale, che offre un ambiente di lavoro stimolante e collaborativo a Bologna o Milano. Con opportunità di crescita professionale e un forte impegno per l'innovazione, i dipendenti possono sviluppare competenze in SAP S/4HANA e Finance Transformation, contribuendo a progetti internazionali significativi. La nostra cultura valorizza la diversità e promuove la condivisione della conoscenza, rendendo ogni giorno un'opportunità per imparare e crescere insieme.
