Global Pharmacovigilance System Specialist

Are you detail-oriented and passionate about regulatory compliance and quality in pharmacovigilance? Would you like to contribute to the robustness and efficiency of a global PV system within an international pharmaceutical company?

At Alfasigma , we are looking for a Global Pharmacovigilance System Specialist to join our Global Pharmacovigilance Department . This role supports the maintenance, quality control, and compliance of key PV processes and documentation, working under the supervision of the Pharmacovigilance Governance Coordinator. You will contribute to ensuring the integrity of PV operations across the company and its partners.

Key Responsibilities

• Manage and maintain Pharmacovigilance Agreements (PVAs) data within tracking systems
• Draft, negotiate and update PVAs and termination letters with third parties and external vendors
• Support the continuous update of the Pharmacovigilance System Master File (PSMF) Annexes
• Coordinate and deliver pharmacovigilance training to internal staff, Field Force, and external vendors
• Support PV KPIs monitoring and contribute to inspection/audit readiness activities
• Perform regulatory intelligence activities and maintain awareness of evolving PV legislation
• Write, review and update SOPs and Work Instructions in line with company standards
• Perform quality control activities on key documents and PV governance trackers
• Ensure the proper management of the pharmacovigilance archive

Requirements

• Degree in Pharmacy or another relevant scientific field (e.G., Biology, Chemistry)
• Previous experience in a pharmacovigilance department (minimum 1–2 years)
• Solid understanding of GVP principles and PV documentation management
• Experience with PV tracking systems and quality oversight processes
• Strong organizational and prioritization skills, with keen attention to detail
• Proficiency in Microsoft Office (Excel, Word, Outlook)
• Fluency in English is required

Location:
Bologna or Milan

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.