Pharmacovigilance (Psmf) Specialist

This role will play a key part in supporting with managing the QPPV office and ensuring the QPPV has access to and regularly receives all relevant information required to demonstrate oversight of the pharmacovigilance (PV) system. In addition, responsible for update and maintenance of the Pharmacovigilance system master file (PSMF). This role will also ensure projects adhere to Good Pharmacovigilance Practice and regulatory requirements.

This role requires you to be a passionate pharmacovigilance professional, who is a dedicated and enthusiastic team player, that strives to gain and maintain an exceptional reputation for Clinigen and their Clients and who is knowledgeable, cares and produces high quality work.

**Key Responsibilities**:

- Develop and maintain an understanding of the different components of the PV system and their interactions.
- Update and maintain the Pharmacovigilance System Master File (PSMF) for the UK, EU and/or global.
- Responsible for the PSMF process, which includes maintaining a system/process (i.e., manage and maintain the PSMF schedule, the allocation and training of PSMF key contributors and ensure the PSMF schedule is kept up to date at all times).
- Responsible for timely collation and compiling of the required data for the PSMF by liaising with relevant key stakeholders and/or the clients.
- Review of the collated information for completeness and accuracy.
- Responsible for timely sign-off of the PSMF as per the procedures.
- Manage the QPPV mailbox and respond to internal and client queries.
- Manage, co-ordinate and prepare for any periodic/ad-hoc QPPV related meetings. Schedule meetings, ensuring relevant key stakeholders are present, collating metrics/data for presentation, taking meeting minutes etc.
- Facilitate and enhance cross-functional communication with the QPPV Office and the global businesses.
- Ensure the QPPV has access to and regularly receives all information required to demonstrate oversight of the global PV system.
- Responsible for ensuring shared storage area such as SharePoint is kept up to date for QPPV oversight.
- Maintain awareness of all relevant national, European and global pharmacovigilance legislations.
- Provide support with XEVMPD updates, if required.
- Support with planned deviations and assess impact to the PV system with integration of newly acquired or approved products and update PSMF as required.
- Support with audits and inspections.
- Perform any ad-hoc activities that arise in relation to the PSMF management, and in the maintenance of processes and systems to assist with QPPV oversight.
- Attend meetings to assess impact to the PV system and decide if changes are significant or non-significant relating to PSMF update.
- Train and mentor junior employees.
- Increase awareness of the PSMF by training relevant individuals on the legislation and company procedure.

**Requirements**:

- Previous experience with QPPV office management and PSMF desired, but not essential.
- Strong PV background relating to post-marketing experience essential. Clinical experience desired but not essential.
- Previous knowledge and experience with XEVMPD beneficial.
- Ability to present complex data/information at all levels of the organisation and externally
- Attention to detail and the ability to work effectively in an environment characterised by tight timelines and changing priorities
- Understanding of impact of emerging regulatory requirements and implications globally
- Proven leadership skills with regards to people, projects, and execution of plans and processes
- Excellent organisational and prioritisation skills and strong analytical / problem solving skills
- Excellent oral and written communication skills and commitment to mentoring / training PV team
- Extensive knowledge of MS Office Applications and systems
- Proven ability to work collaboratively within a matrix and/or cross-functional environment. Ability to build relationships with key internal and external customers
- Self-motivated and organised, with the ability to work unsupervised for periods of time

**Benefits**
- 27 days holiday plus 8 bank holidays
- Pension contributions 4.5% matched
- Life assurance 4 x annual salary
- Flexible Benefits Platform with £25/month Company contribution
- Annual salary review
- Independent financial advice service
- Enhanced Employee Assistance Programme
- Shopping discounts with retailers
- Long service awards
- Recognition scheme & employee of the year awards