Pharmacovigilance Agreement Senior Specialist

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

Descrizione del lavoro

A multinational pharmaceutical company is seeking a Pharmacovigilance Agreement Senior Specialist to oversee agreements and ensure regulatory compliance. The ideal candidate should have at least 5 years of relevant experience, a Bachelor's degree in a related field, and strong collaboration skills. This position offers a full-time employment opportunity based in Lombardia, Italy.

Competenze

• Minimum of 5 years experience in pharmacovigilance at pharmaceutical companies or healthcare organizations.
• Experience with operational procedures and regulations, especially EU regulations.
• Strong knowledge of PV legislation and guidelines.

Mansioni

• Preparation, review, and maintenance of Pharmacovigilance Agreements with business partners.
• Assist in developing and updating procedures and PV agreement templates.
• Collaborate with management on Pharmacovigilance System Master Files.

Conoscenze

Project Management capabilities

Collaboration with internal teams

Good knowledge of English

IT skills in Microsoft Office

Formazione

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

Descrizione del lavoro

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