THE COMPANY

Fusion Pharma provides a bespoke consultancy service within the pharmaceutical industry for Regulatory Affairs, Quality Assurance, Pharmacovigilance and Medical activities. Our first priority is to have a positive workplace culture where employees feel respected and valued. To achieve this, we only hire talented, dedicated and passionate individuals who share these same values. We take our work-life balance seriously and offer remote and flexible working along with 6 weeks holiday each year and an attractive Vitality private healthcare plan. By prioritising this, our clients benefit from our energetic and committed team who work hard to make our clients’ goals, their goals!

We continue to grow and are delighted to be recruiting for our next member of the team to head up the Pharmacovigilance Department, reporting into the Managing Director. This role is suited to someone who is enthusiastic, enjoys a challenge and is ready to make their next career move.

 

THE ROLE

There are two aspects to this role as it is split between working on client projects and company projects. You will maintain an oversight of both aspects and ensure compliance of all PV deliverables.

1) Client projects

There are vast opportunities to utilise your experience and develop it further by supporting our established ‘big pharma’ clients through to start-ups, such as:

  • Being responsible for a portfolio of products within our outsourcing model
  • Work collaboratively with internal and external stakeholders to ensure the PV aspects of projects are managed in line to meet clients’ expectations
  • Representing the PV department during internal / external audits or Health Authority inspections

2) Company projects

As a fast-growing consultancy you will be involved in business development and continuous improvement activities, such as:

  • Project management
  • Cross-functional working with Quality, PV and Medical functions
  • Writing SOPs, blogs and marketing materials
  • Keeping your knowledge current within your SME area
  • Growing your team in line with business needs

 

THE ESSENTIAL EXPERIENCE

  • Solid knowledge of UK and EU Pharmacovigilance principles concerning clinical trials and post marketing activities
  • Demonstrable experience in all aspects of PV activities e.g. case processing, aggregate reporting, regulatory reporting, signal detection etc.
  • Direct experience in:
    • PV systems development and implementation
    • Health Authority inspections
    • Implementation of EU PV legislation
    • Writing / delivering PV training
    • Handling of non-serious and serious adverse events
  • Proficient in writing PV documentation such as PBRER, DSUR, RMP, PSMF and SOPs
  • Good knowledge of GxP requirements.

Advantageous experience includes line management and previously working within a consultancy environment.

 

THE ESSENTIAL REQUIREMENTS

  • Life Sciences degree (minimum)
  • Fluent in written and spoken English with excellent communication skills and attention to detail
  • Minimum of 5 -7 years PV experience (aligned with essential experience described above)
  • Proficient in Microsoft Office applications with the ability to learn new electronic systems
  • Proven competency in working autonomously and multi-tasking in fast-paced environment
  • Committed to representing Fusion Pharma to a high standard, face to face and remotely
  • Role requires an enthusiastic, motivated and driven individual
  • The successful candidate will have a professional work setting for company video calls and a high-speed, reliable internet connection

 

THE BENEFITS

  • Salary negotiable depending on experience
  • Permanent and full time
  • Flexible working hours
  • Remote working
  • 6 weeks holiday
  • Private healthcare
  • Pension

 

Please send your CV to hello@fusion-pharma-limited.com if you are interested in this position.