Head of Global Pharmacovigilance Governance

Are you passionate about ensuring compliance, quality, and performance in pharmacovigilance systems on a global scale? Would you like to play a key strategic role in shaping PV governance in an international pharmaceutical company?

At Alfasigma , we are looking for a Head of Global PV Governance to lead the team responsible for the quality and performance oversight of the Pharmacovigilance (PV) system. This role will oversee the Global PV System . The selected candidate will be accountable for ensuring regulatory compliance, driving global consistency, and supporting effective collaboration across internal stakeholders and external partners.

Key Responsibilities

• Lead and coordinate the Global PV Governance team, ensuring alignment across compliance, systems coordination, and affiliate support.
• Oversee PV Compliance activities including NC/CAPA management, regulatory intelligence, quality control, and audit readiness.
• Supervise the Global PV System, managing the Global PSMF, PV Agreements (PVAs), and PV training programs.
• Ensure effective coordination with affiliates, supporting local PSMFs, PVAs, SOPs, and training initiatives.
• Foster continuous improvement, harmonization, and operational excellence within the global PV governance framework.
• Collaborate with senior leaders and business partners to align PV governance with broader company strategies.

Requirements

• Advanced degree in scientific disciplines (e.g., Pharmacy, Medicine, Chemistry, Biology or related fields).
• Minimum 10 years of experience in pharmacovigilance, with at least 5 years in a leadership role.
• Strong expertise in GVP, international PV regulations, and governance of PV systems.
• Proven track record in managing complex PV systems and leading global teams.
• Deep knowledge of compliance processes, audit management, and regulatory intelligence.
• Excellent communication, negotiation, and stakeholder management skills.
• Strategic thinking, strong problem-solving capabilities, and results orientation.
• Fluency in English is required.

Company:

Alfasigma is a global pharmaceutical company founded over 75 years ago in Italy, where it is headquartered (in Bologna and Milan). The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa. It has offices in many countries, including Italy, the US, Spain, Germany, Mexico, and China; production sites in Italy (Pomezia, RM; Alanno, PE; Sermoneta, LT; Trezzano Rosa, MI), Spain (Tortosa, Baix Ebre), and the United States (Shreveport, Louisiana); and R&D labs in Italy (Pomezia and Bergamo). Alfasigma employs approximately 4,000 people dedicated to research, development, production, and distribution of medicinal products, contributing to its mission to provide better health and a better quality of life for patients, caregivers, and healthcare providers. It focuses on three main therapeutic areas: Gastroenterology, Vascular, and Rheumatology. Its portfolio spans from primary care to specialty care, rare disease medications, and consumer health products, including medical foods and nutraceuticals.