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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