Senior PV Manager (Line Management)
My Large Pharmaceutical client is looking to hire a Senior PV Manager into their European team. This is a senior role in the organisation, and will incorporate Line Management.
- To manage and maintain the UK Pharmacovigilance (PV) Quality System ensuring it is fully operational at all times, has a complete set of up to date Quality documents and a local PV system file which is monitored, reviewed and conducted in a compliant and efficient manner, in line with global/regional regulatory requirements and Companies policies and procedure
- To deputise for the Head of PV in UK including representing UK PV in front of a cross functional audience at a local, regional and global level, including Global PV and the UK MT to ensure PV business contingency is available at all times
- Lead, initiate and implement PV related projects impacting either the UK affiliate and/or EMEA HQ and act as PV representative for Special Projects as the business needs dictate (e.g. Drug Safety and Healthcare Compliance Projects) in collaboration with the Global PV function.
- Degree in a science/healthcare-related subject.
- Understanding of European regulatory and PV environment and code(s) of practice
- Good understanding of PV principles, concepts, practices & standards
- Understanding of Good Clinical Practice concepts
- Understanding of country specific variations and Astellas processes and procedures
- Line management experience (ideally)
- Pharmacovigilance experience within the pharmaceutical industry is essential
- Experience with audits and/orinspections and CAPA management
Great company culture - placed a number of candidates within the business and team.
Development - always have clear defined path
Work Life balance - Core hours 10-4pm
Please email email@example.com or apply on Pharmiweb.