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Head of Safety UK and ROI & UK QPPV

Location: 

Slough, Berkshire, United Kingdom

Job Function:  Drug Safety & Pharmacovigilance
Job ID:  65598

Head of Safety UK and ROI & UK QPPV

 

To strengthen our Drug Safety Team based in our Slough site in the UK, we are looking for a talented individual to fill the position of: Head of Safety UK and ROI & UK QPPV. 
 

As the Head of Safety UK and ROI & UK QPPV you will accountable for ensuring Pharmacovigilance systems, operations and procedures are in place within the local organization for UK and Republic of Ireland territories of the BII (British and Irish) Affiliate.

 

You like to work in an environment where you can:

  • Be the primary contact for pharmacovigilance at the Affiliate.
  • Be the local UK QPPV and nominated contact person for pharmacovigilance as notified to the local Health Authorities.

 

You will contribute by:

  • Maintaining a functional connection with the EEA Qualified Person for Pharmacovigilance (QPPV) e.g. participating in regular Local Safety Officer (LSO) meetings organized by corporate Patient Safety.
  • Ensuring maintenance of local Pharmacovigilance System Master File (PSMF) in collaboration with the EEA QPPV office.
  • Implementing and maintaining a pharmacovigilance system for the UCB products authorized in the territory and ensure compliance with applicable regulatory and company requirements.
  • Working in close collaboration with corporate Patient Safety teams to ensure that local obligations are managed and compliance to local authorities is maintained.
  • Providing input into global/local processes to secure compliance.
  • Maintaining quality management system related to the pharmacovigilance, including management of Standard Operating Procedures (SOPs), Associated Instructions (AIs) and documents (e.g. forms, templates) to describe local processes and requirements and perform regular gap analysis as needed to ensure alignment with global SOPs.
  • Maintaining oversight of local deliverables delegated to service providers;
  • Ensuring timely management of deviations and risk mitigation by defining appropriate CAPAs and ongoing trend analysis as appropriate.

 

Interested? For this position you’ll need the following education, experience and skills:

  • Expert in pharmacovigilance, with an in-depth expert knowledge of associated regulatory requirements.
  • Scientific background in Central Nervous System and/or immunology therapeutic areas is desirable.
  • Ability to plan, organize, prioritize, and execute multiple tasks within assigned objectives to aim for 100 % compliance.
  • Have strong interpersonal skills, especially in individual leadership and adaptability.
  • Strategic leadership, qualities of authenticity, resilience and adaptability;
  • Role model; high level of integrity and honesty, both internally and externally coupled with the ability to inspire direct team and others.

 

Why you should apply

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

 

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.


Job Segment: Immunology, Law, Quality Manager, Pharmacovigilance, Compliance, Healthcare, Legal, Quality

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