Head of PV, UK and Ireland
We are partnering with a well-known global Pharmaceutical client with the hiring of a Head of Pharmacovigilance. This is a sole responsibility position working as part of a wider med team.
A business that is passionate, innovative and committed to growth. One that aims to lead the way within their market and continually improve their product portfolio. Our client has impressive pipeline with several products being launched over the next three years.
This opportunity will be responsible for leading and managing all activities related to safety management for the companies product portfolio. You must have a solid background within PV to be considered and experience in either OTC, prescriptions, dermatology or medical devices would be an advantage.
You will be responsible for ensuring the timely handling of all local PV activities in line with the current national and global PV requirements. Managing all PV operations by delegation of the UK QPPV.
Other duties include the following:
* UK and Ireland contact person and local expert of PV. Adhering to current best practice and future developments. Notify GPV, UK QPPV and update SOPs with any changes in the UK PV legislation or national requirements.
* Receive and respond to PV correspondence from the UK Regulatory Authority in conjunction with the UK QPPV and other departments, as required.
* Comply with and maintain local PV agreements with licence partners and any other company or organisation that potentially handles safety information on the company's products.
* Ensuring the PV/MI mailbox and portal are maintained and reviewed each business day.
* Ensure accurate and timely data entry of adverse event/ safety information, including ongoing discussions with GPV regarding case handling, coding practices etc.
* Appropriate submission and compliance monitoring of individual and periodic safety reports to the UK Regulatory Authority and responsible Ethics Committee(s).
* Maintain Key Performance Indicators of the PV activities; share their results with the UK QPPV and GPV.
* Ensuring a national system is in place for 24-hour contact regarding safety-related issues.
* Organise with the UK QPPV and QA an audit program of partners and services providers that contribute to pharmacovigilance activities. Ensure appropriate CAPA management.
* Communicate changes on product SPCs and PILs to external bodies; alert BNF, MIMS, C&D, PJ and UKMI to changes to Product Licences and SPCs, update on website and communicate changes to internal customers.
* Deliver training support on MI and defined product topics.
* Review promotional material in line with Code of Practice
* Ensure compliance with ABPI.
To be considered you must:
* Be degree educated within Pharmacy, Medical, Nursing or have a Life Science degree
* Demonstrable experience leading PV activities
* Excellent knowledge of PV regulations and legislation for UK and Ireland
* Demonstrable MI experience
* Strong communicator
* Excellent attention to detail
* Team player
What is on offer?
A competitive salary banding, 15% bonus, competitive car allowance £7,500, private healthcare, critical illness cover, pension contribution of up to 12%, 25 days annual leave (opportunity to buy an extra 5 should you wish).
Product Quality Assurance
Attention To Detail