Pharmacovigilance Agreement Senior Specialist

Overview

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

Responsibilities

• Preparation, review, and maintenance of Pharmacovigilance Agreements (PVAs) with Zambon business partners (including distributors, licensees, licensors) and affiliates, in accordance with Zambon standard procedures and applicable regulations.
• Assist in the development and update of relevant 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 and consistency with the EU PSMF.
• Support the monitoring of key performance indicators of the PV system.
• Supports QPPV to ensure adequate and continuous oversight of the Zambon Pharmacovigilance System quality and performance.
• Support audits and inspections, contributing to, and monitoring of, corrective and preventative actions related to the PV system performance.

What we are looking for

• Bachelor’s degree in Pharmaceutical Chemistry, Physical Sciences, or a related scientific discipline.
• A minimum of 5-year experience in the pharmacovigilance department of pharmaceutical companies or healthcare organizations.
• Experienced in operational, pharmacovigilance procedures and regulations, with particular emphasis on 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 effectively with internal teams and external business partners.
• IT Tools (Microsoft Office tools).

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Other and Science

Industries

• Pharmaceutical Manufacturing