QA R&D PHARMACOVIGILANCE SPECIALIST

Pharma Point Srl; Milano; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company is seeking a Quality Assurance Pharmacovigilance Specialist in Milan. The candidate will manage quality assurance activities, ensuring compliance with Good Pharmacovigilance Practices and overseeing audits. Previous experience in the pharmaceutical industry and strong knowledge of quality assurance standards are required. Fluent English is essential, along with a willingness to travel periodically.

Competenze

• Prior experience in a similar role within pharmaceutical companies or PV CROs.
• Strong understanding of quality assurance standards.
• Willingness to travel periodically.

Mansioni

• Ensure compliance with Good Pharmacovigilance Practices.
• Manage SOPs/work instructions related to pharmacovigilance.
• Oversee and coordinate pharmacovigilance audits.

Conoscenze

Experience in pharmaceutical quality assurance

Understanding of Good Pharmacovigilance Practices

Fluent in English

Descrizione del lavoro

Overview

For a leading pharmaceutical company, Pharma Point is looking for a Quality Assurance Pharmacovigilance Specialist.

The selected candidate will be responsible for ensuring the development, implementation, and maintenance of the company’s Quality Management System in the area of Pharmacovigilance, in accordance with the quality standards of the Group.

Key Responsibilities

• Management of Quality Assurance activities to ensure compliance with Good Pharmacovigilance Practices (GVP) and applicable regulations
• Management of SOPs / Work Instructions related to pharmacovigilance processes
• Oversight and coordination of pharmacovigilance audits
• QA review / approval of deviations, CAPAs, and change controls related to PV topics
• Support in the review and update of the Pharmacovigilance System Master File
• Risk assessment management to prioritize audits (affiliates, partners, vendors, PV system)

Qualifications

• Previous experience in a similar role within pharmaceutical companies and / or PV CROs
• Strong understanding of Quality Assurance standards
• Willingness to travel periodically
• Fluent in English, both written and spoken