Quality Assurance Pharmacovigilance Specialist

Pharma Point; Roma; In loco; EUR 40.000 - 65.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company is seeking a Quality Assurance Pharmacovigilance Specialist in Rome, Italy. You will manage quality assurance activities, ensuring compliance with Good Pharmacovigilance Practices and applicable regulations. The ideal candidate should have experience in a similar role, a strong understanding of quality assurance standards, and be fluent in English. Willingness to travel is also required.

Competenze

• 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.

Mansioni

• Management of Quality Assurance activities for compliance with Good Pharmacovigilance Practices.
• 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.

Conoscenze

Experience in pharmaceutical companies

Understanding of Quality Assurance standards

Fluent in English

Descrizione del lavoro

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)

Requirements

• 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