A global pharmaceutical company is looking for a pharmacovigilance professional to join their team on a permanent basis in Oxfordshire.
This role is predominantly focusing on covering clinical safety, oversight of the pharmacovigilance system and ensuring compliance.
- Ensure that all current PV requirements for interventional clinical trials are effectively incorporated into company processes and documented in SOPs
- To ensure full compliance with efficient processes for safety-related aspects of all organised data collection systems, which comprise: interventional clinical trials, non-interventional studies (NIS) and patient data collection systems (PDCS).
- Ensure that all changes in legislation relating to PV requirements for interventional clinical trials, eg the new EU Clinical Trials Regulation, are proactively incorporated into Ipsen processes so that there is no loss of compliance and business continuity is maintained
- Define relevant Key Performance Indicators (KPIs) and quality standards and ensure that these are measured and monitored, and implement corrective and preventive actions (CAPAs) as required
- Implement corrective and preventive actions (CAPAs) as required for any deviations from the NIS PV requirements
- For all audits and inspections, serve as the GPS expert for these processes
- Act as the primary source of subject-matter expertise to address any questions from company staff or from external contacts regarding these activities and processes
This company has a very exciting pipeline and as a result is in the process of expanding it's operations in the UK.
If this role is of interest, don't hesitate to apply!
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales