CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency, dialysis and nephrology & rare disease. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives.
A position has arisen in the Pharmacovigilance Quality Assurance (PVQA) 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.
- 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 CSL Vifor
- 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
- Define key functions and methods of Global Drug Safety Quality Assurance together with Senior Management of CSL Vifor QA & CMRS and GDS.
- Assess overall training needs for Pharmacovigilance with input from Senior Management and staff and help to develop the CSL Vifor PV training
- Provide PV training to CMRS staff as well as special training groups from business and sales.
Procedural Documentation / Contracts
- Regularly review valid GDS procedural documents to assess compliance with applicable regulatory requirements; and to assess internal and cross procedural consistency
Audits / Inspections
- Establish and manage annual internal PV audit programme based on a risk assessment and including audits of departments, processes, affiliates, partners and vendors
- Analyse results of PV audits in conjunction with the EUQPPV and communicate issues and areas of risk to Senior Management
- Lead global PV inspection activities, including preliminary preparation, internal host support and document/interviewee facilitation
- 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 %)
- 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