Sr. Manager, Global PV System Management & Alliance

Alfasigma; Bologna; In loco; EUR 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

Alfasigma is seeking a Senior Manager for Global Pharmacovigilance System Management & Alliance to oversee governance, alignment, and compliance across PV activities. You will work with the QPPV and Global PV Director to maintain critical PV systems and agreements.

You will coordinate PVAs, support PSMF updates, lead PV training, audits, and inspections, and ensure PV documentation meets GVP and ISO 9001 standards across global operations.

Competenze

• Degree in Pharmacy, Life Sciences, or related field.

Mansioni

• Coordinate, review, and maintain global Pharmacovigilance Agreements (PVAs) with partners.
• Support the Global PV Governance Director and QPPV in maintaining the Pharmacovigilance System Master File (PSMF).
• Plan, coordinate, and oversee PV training programs for employees, vendors, and affiliates.
• Review and approve PV training materials to ensure regulatory alignment.
• Participate in internal and external PV audits and inspections.
• Ensure timely updates of the global product list used for PV.
• Oversee Regulatory Intelligence activities including monitoring and impact assessments.
• Collaborate with cross-functional teams to drive PV quality and compliance.

Conoscenze

GVP Knowledge

Stakeholder management

Quality systems

GxP awareness

English proficiency

Formazione

Degree in Pharmacy or Life Sciences

Strumenti

MS Office

Descrizione del lavoro

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Sr. Manager, Global PV System Management & Alliance

Alfasigma is a privately held global healthcare company founded over 75 years ago in Italy, where it remains headquartered today in Bologna and Milan. The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa.

Over three years ago, we embarked on a transformative journey to become a truly global innovative healthcare company with a leading focus on Gastrointestinal (GI) health. We have experienced remarkable growth, nearly doubled our revenues, expanding geographically, and integrating several key acquisitions. We have also evolved our portfolio, expanded into rare and specialty segments, and strengthened our pipeline and people's capabilities.

But our journey is far from complete! In fact, this is just the beginning of a bold new chapter in Alfasigma's history. We are committed to advancing innovation and leveraging our deep expertise to provide better health and a better quality of life for patients and consumers worldwide and expand our reach across diverse markets.

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.
• 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

Why Join Alfasigma:

At Alfasigma, we foster a culture where the courage to innovate is key to our success.
We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development.

Our commitment to people and patients is at the heart of everything we do. We value diversity and welcome individuals with unique perspectives and experiences. We believe that open-mindedness, collaboration, and a shared passion for innovation are essential to achieving meaningful progress.

Join Alfasigma and become part of a forward-thinking team dedicated to shaping the future of the pharmaceutical industry.