Quality Assurance Pharmacovigilance Specialist

Buscojobs; Lombardia; In loco; EUR 35.000 - 55.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company is seeking a Quality Assurance Pharmacovigilance Specialist in Milan, Lombardy. The role focuses on managing the Quality Management System within Pharmacovigilance, ensuring adherence to industry standards. Candidates should have prior pharmacovigilance experience, a solid understanding of QA standards, and be willing to travel.

Competenze

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

Mansioni

• Management of Quality Assurance activities to ensure compliance with Good Pharmacovigilance Practices.
• Oversight and coordination of pharmacovigilance audits.
• QA review/approval of deviations, CAPAs, and change controls related to PV.

Conoscenze

Quality Assurance Standards

Pharmacovigilance Practices

Risk Assessment

Auditing

Documentation

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

Quality Assurance Specialist • Milan, Lombardy, Italy