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Quality Assurance Pharmacovigilance Specialist
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Quality Assurance Pharmacovigilance Specialist
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
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.
- 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)
- 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
* Il benchmark retributivo si basa sugli obiettivi retributivi dei leader del mercato nei rispettivi settori. È pensato per orientare gli utenti Premium nella valutazione delle posizioni aperte e aiutarli a negoziare la propria retribuzione. Tale benchmark non è fornito direttamente dall'azienda, quindi la retribuzione effettiva potrà risultare anche notevolmente superiore o inferiore.