AX-7147 Head of Pharmacovigilance UK / Regulatory Oversight
New position within an established Pharma Company to lead their UK and Ireland PV function. Excellent opportunity to take on a lead role acting as the Responsible Person for the affiliate and providing oversight and management of outsourced work, the strategy for all contractual requirements and ensuring all processes are in place for complaint handling.
Established Pharma Organisation – strong portfolio
Stand-alone UK & Ireland position
Office based in Cambridge with flexibility for some home working
Primary responsibility for UK and Ireland specific PV activities relating to pipeline assets, business development and new marketing authorisations as well as post-approval PV activities associated with the commercialised product portfolio.
You’ll provide operational leadership and technical expertise to ensure compliant performance of PV activities including vendors. You’ll also ensure that portfolio risks around safety and Pharmacovigilance are optimally managed including establishing and maintaining credible and long-term and partnerships with internal and external stakeholders around all aspects of PV.
Ideally have a knowledge of the UK and Ireland pharmaceutical regulatory environment to provide strategic and managerial oversight and advice to the business. This is a minor part of the objectives and the emphasis is to find a PV professional with knowledge of UK regulatory framework.
QUALIFICATIONS / EXPERIENCE REQUIRED:
Educated to degree level (Bachelors or Masters) in a relevant discipline.
A proven pharmacovigilance strategist and thought leader with a successful track record of ensuring business success in an affiliate position and specifically within UK and Ireland.
Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.
Competitive, including a flexible pot and additional bonus.
For a confidential discussion please telephone Christian Simon at AXESS Limited on 020 8560 2300.
To apply, please click APPLY ONLINE.
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