Pharmacovigilance Agreement Senior Specialist

Pharmacovigilance Agreement Senior Specialist

Apply for the Pharmacovigilance Agreement Senior Specialist role at Zambon, a multinational pharmaceutical company dedicated to innovation and patient health.

The Role:

Zambon S.p.A. is seeking a Pharmacovigilance Agreement Senior Specialist to join its Drug Safety Unit.

Main Responsibilities:

• Preparation, review, and maintenance of Pharmacovigilance Agreements (PVAs) with Zambon business partners (distributors, licensees, licensors) in accordance with standard procedures and applicable regulations.
• Assist in the development and update of procedures, PV agreement templates and pharmacovigilance clauses to ensure consistency and regulatory compliance.
• Collaborate with the management of Zambon EU, UK Pharmacovigilance System Master Files (PSMFs), and other national PSMFs, ensuring alignment with the EU PSMF.
• Support the monitoring of key performance indicators of the PV system.
• Support QPPV to ensure continuous oversight of the Zambon Pharmacovigilance System quality and performance.
• Support audits and inspections, contributing to corrective and preventative actions related to PV system performance.

Qualifications:

• Bachelor’s degree in Pharmaceutical Chemistry, Physical Sciences, or related discipline.
• Minimum of 5 years experience in pharmacovigilance at pharmaceutical companies or healthcare organizations.
• Experience with operational procedures and regulations, especially EU regulations; knowledge of quality assurance basics preferred.
• Good knowledge of English language.
• Strong knowledge of PV legislation and guidelines.
• Project Management capabilities/organizational skills.
• Ability to collaborate with internal teams and external partners.
• IT skills in Microsoft Office.

Seniority level

• Mid‑Senior level

Employment type

• Full‑time

Job function

• Other and Science

Industries

• Pharmaceutical Manufacturing