QA R&D PHARMACOVIGILANCE SPECIALIST

Pharma Point Srl; Milano; In loco; EUR 40.000 - 65.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company, Pharma Point Srl, seeks a Quality Assurance Pharmacovigilance Specialist in Milan. The role focuses on ensuring compliance with quality management systems and pharmacovigilance practices. Ideal candidates will have experience in pharmaceutical settings and be fluent in English.

Competenze

• Previous experience in a similar role within pharmaceutical companies or PV CROs is essential.
• Strong understanding of QA standards is crucial.
• Willingness to travel periodically.

Mansioni

• Manage Quality Assurance activities to ensure compliance with Good Pharmacovigilance Practices.
• Oversee pharmacovigilance audits and manage relevant SOPs.
• QA review/approval of deviations and change controls.

Conoscenze

Quality Assurance standards

Compliance with Good Pharmacovigilance Practices

Risk assessment management

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