Contract EU Pharmacovigilance Project Manager
CK Clinical are recruiting for a EU Pharmacovigilance Project Manager to join a rare disease pharmaceutical company with both marketed products and ongoing clinical trials across the EU and UK.
This will be a fully remote position.
RESPONSIBILITIES:
As EU Pharmacovigilance Project Manager you will be instrumental in maintaining the integrity and effectiveness of our pharmacovigilance practices. Your role will include the integration of PV systems with our US parent company, ensuring regulatory compliance, preparing for inspections, managing outsourced PV activities, and upholding our quality management systems.
Key duties will include:
- Supporting the seamless integration of PV systems post-acquisition, aligning with both US and EU/UK regulatory standards
- Working with QA to maintain the Quality Management System, including handling deviations, implementing Corrective and Preventive Actions (CAPAs) and performing effectiveness checks
- Leading periodic reviews and update of Standard Operating Procedures (SOPs) relevant to pharmacovigilance activities
- Liaison with wider department to update and maintain the Pharmacovigilance System Master File (PSMF) ensuring it accurately reflects the PV system
- Provision of robust support to the Qualified Person for Pharmacovigilance (QPPV) in all relevant aspects of PV
- Oversight, review and auditing of CROs and third party vendors, ensuring compliance with Safety Data Exchange Agreements
As EU Pharmacovigilance Project Manager you will require:
- A degree in Pharmacy, Medicine, Nursing, or a related life science field
- Extensive pharmacovigilance experience gained within the pharmaceutical sector
- Comprehensive knowledge of PV regulatory requirements in the EU and UK
- Proven track record of managing outsourced PV activities and vendor relationships
- Exceptional organizational and project management skills
Up to £750 per day, outside IR35
Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 56611 in all correspondence.