Pharmacovigilance Agreement Senior Specialist

Zambon; Bresso; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company in Italy is seeking a Pharmacovigilance Agreement Senior Specialist to join its Drug Safety Unit. The ideal candidate will have a Bachelor's degree in a related scientific discipline and at least 5 years of experience in pharmacovigilance within pharmaceutical companies. Responsibilities include the preparation and maintenance of agreements, monitoring performance indicators, and ensuring regulatory compliance.

Competenze

• Minimum of 5-year experience in pharmacovigilance or healthcare.
• Strong understanding of EU regulations related to pharmacovigilance.
• Knowledge of quality assurance basics preferred.

Mansioni

• Prepare and maintain Pharmacovigilance Agreements with partners.
• Assist in developing relevant procedures and templates.
• Monitor key performance indicators of the PV system.
• Support audits and inspections related to PV.

Conoscenze

Pharmacovigilance procedures

Project Management

Collaboration

Communication skills

IT Tools

Knowledge of English

Formazione

Bachelor’s degree in Pharmaceutical Chemistry, Physical Sciences, or related scientific discipline

Strumenti

Microsoft Office

Descrizione del lavoro

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