Quality Assurance Pharmacovigilance Specialist
Descrizione dell'offerta
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