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
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