Pharmacovigilance Quality Management Lead

Vor 2 Tagen

Glattbrugg, Schweiz Vifor Pharma Vollzeit

Vifor Pharma is experiencing rapid pipeline optimization and growth in Nephrology, Cardio-Renal and Rare diseases. A position has arisen in the Pharmacovigilance Quality Assurance (GPvP) group in a leadership role to manage a talented team of PV Quality Auditors and take responsibility for all PV Quality Assurance related topics within the wider Clinical and PV Quality group. You will be an experienced professional within PVQA or an experienced PV Operations professional with significant exposure to PVQA as part of your role. On offer is the opportunity to work within a growth pharmaceutical company with significant pipeline and commercial product and shape the capabilities of a small group of PV auditors to provide your main stakeholders with high confidence levels in a highly regulated sector.

**Responsibilities**
- Manage the further development and implementation of a risk-based global PV Audit program (including audits of Affiliates, Distributors, Contractors, special programs and systems) in support of clinical safety and Pharmacovigilance activities related to Vifor products
- Manage a robust Pharmacovigilance quality system at Vifor Pharma
- Monitor and assess global safety processes and procedures for consistency and compliance with global laws, regulatory requirements and Vifor policies and procedures
- Provide guidance and expert advice and act as point of contact in relation to interpretation of PV regulations, quality improvement, process and program initiatives and risk assessment for the Global Drug Safety Department (GDS) and all other stakeholders (Medical Affairs, Regulatory Affairs, Clinical Development, etc.) which are impacted by Good Pharmacovigilance Practices (GPvP).
- Lead the preparation, hosting and follow up of Regulatory Authorities inspections related to Pharmacovigilance activities at Vifor Pharma, including Affiliates
- Monitor deviations at Global drug safety, escalate as necessary and maintain CAPA oversight for all audits and Inspections
- Generate and provide metrics, status and trend reports and other information, as required by management

**Minimum Requirements**
- Sound knowledge of worldwide regulations pertaining to GPvP for pharmaceutical products
- Knowledge and experience in auditing
- Knowledge of quality management systems
- University degree or equivalent in health sciences, nursing, pharmacy or related field
- 2 to 5 years plus experience in PV auditing with EU/FDA /global regulatory requirements
- Minimum 5 years’ experience in the pharmaceutical industry
- Willingness to travel (approx. 25 %)

**Preferred Requirements**
- Experience in drug safety operational / medical role
- Knowledge regarding the use of electronic systems in a regulated environment
- Knowledge of drug development process within a regulatory environment

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