Quality Assurance Pharmacovigilance Specialist

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

Descrizione del lavoro

A leading pharmaceutical company is seeking a Quality Assurance Pharmacovigilance Specialist to manage Quality Assurance activities and ensure compliance with Good Pharmacovigilance Practices. The ideal candidate will have experience in the pharmaceutical sector and a strong understanding of quality assurance standards. Fluency in English and willingness to travel are necessary. This role is based in Milan, Italy.

Competenze

• Previous experience in a similar role within pharmaceutical companies and/or PV CROs.
• Strong understanding of Quality Assurance standards.
• Willingness to travel periodically.

Mansioni

• Management of Quality Assurance activities to ensure compliance with GVP.
• 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

Quality Assurance standards

Good Pharmacovigilance Practices (GVP)

Fluent English

Descrizione del lavoro

Quality Assurance Pharmacovigilance Specialist

For a leading pharmaceutical company, Pharma Point is looking for a

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