Principal PV Process Leader in Hertfordshire
Mary Bolt is recruiting for a Principal PV Process Leader to join a research-focused healthcare company at their site based in Hertfordshire on a permanent basis.
Our client is a global pharmaceutical company providing an innovative range of diagnostic solutions and medicines.
The role is based at our client's site in Hertfordshire which is commutable from many towns from Middlesex to Cambridgeshire. There are good road and public transport networks and London is easily reachable. Hertfordshire boasts many landmarks as well as beautiful countryside.
The main purpose of the role will be to:
- Take the responsible lead role in the design, development, maintenance & support of one or more core Global Drug Safety processes, that are required to deliver effective scientific safety activities and/or PV system activities (e.g. ICSR management, signal management, and risk management).
- Serve as the principal subject matter expert (SME) for the assigned area(s) of process, working either in close partnership with accountable Global Process Owners and Business Process Owners.
- Collaborate and closely interface with internal policy governance bodies/stakeholders (e.g. EU QPPV, Drug Safety Committee, GVP Council, etc.) in adapting core processes in line with business needs and external requirements.
Further responsibilities will include:
- Maintaining expert knowledge of key regulatory and legislative changes and scientific best practices in the assigned SME area(s) and ensuring future changes are anticipated and planned.
- Providing SME input/leadership into activities designed to promote continuous improvement, and gather broad organizational input to potential process improvements and ideas or opportunities for further innovation as well as providing SME input/leadership to project prioritisation and capacity management activities.
- Influencing externally in the assigned areas of expertise (e.g. involvement in expert working groups or industry associations, external policy influence) and promoting activities externally (e.g. via publications or scientific conferences) as well as networking with internal & external groups to understanding their needs and ideas; identifying and anticipating solutions and working collaboratively to find solutions.
To succeed in this role, you will come from a background in:
- Educated to degree level or above in life science or a related field with significant experience in pharmacovigilance and extensive experience in managing PV Agreements/Contracts, and/or SDEAs.
- Demonstrable 'hands on' experience of delivering or managing safety and pharmacovigilance activities described by the assigned safety processes as well as practical experience of applying business process improvement methodologies and a proven ability to influence external policy.
- The ability to operate effectively in, and lead as needed, multi-functional matrix teams with excellent written and verbal communication skills and the ability to present and critically discuss clinical data in relation to its significance and impact on the core safety processes in both internal and external discussions.
For more information or to apply for this position, please contact Mary Bolt on 01438 768717 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL44063 in all correspondence.