Associate Director, Patient Safety Excellence

Location: Barcelona, Spain (on-site) 3 days working from the office / 2 days working from home

• Act as QPPV Pharmacovigilance (PV) Expert, continually strengthen QPPV oversight of the pharmacovigilance system, reach and influence internally and externally, thus driving gold standard pharmacovigilance quality, compliance and efficiency for AstraZeneca.
• In support of PV Excellence, manage and oversee QPPV Office deliverables; for example Pharmacovigilance System Master File (PSMF), Summary of Pharmacovigilance System (SPS), AstraZeneca profile in EudraVigilance and PRAC output monitoring,
• Contribute to continuous improvement projects relevant to the scope of the QPPV function. 

Typical Accountabilities

• Deliver according to the QPPV Office Operating Model to ensure PV System Quality and Compliance and strengthen QPPV oversight and influence. This includes, but is not limited to, the following activities:
  
  • Coordinate, manage and drive the review and update of the Pharmacovigilance System Master File (PSMF)
  • Triage and handling of PSMF & PRAC oversight related matters requiring QPPV input and/or awareness.
  • Monitor PRAC outputs as per SOP and guidelines. 
  • Develop standardised best practice, templates, authoring,  instructions and guidance for production of Patient Safety outputs in relation to e.g., PSMF.
  • As relevant interpret and validate current, new and changing legislation and contribute to interpretation and impact analysis 
  • Contribute to the EU QPPV’s management and oversight of the PV Quality System.  
  • Coordination and ownership of the lifecycle management of nominated processes (for example; EU QPPV Standard and PSMF and SPS Standard Operating Procedure (SOP).
  • Maintain and improve, as relevant, reporting tools and analysis processes to facilitate pharmacovigilance oversight.
  • Provide process training to CMO staff and other functional groups, including the PSMF Coordinator back up, as necessary.
  • Coordinate and manage AstraZeneca’s profile in EudraVigilance, including oversight of user access (Trusted Deputy role).
  • Provide specialist knowledge and support to be recognised as an expert and source of reference for safety teams and other stakeholders.
  • Upon request participate in and/or support activities for GVP audits/inspections.
  • Undertake other nominated tasks as requested; for example contribution to and coordination of projects led by the QPPV Office
  • Work collaboratively with other skill groups or functions to ensure alignment of activities and priorities, sharing of best practices, etc.
  • Establish a culture of continuous improvement, high performance, flexibility and quality emphasising a “can do” attitude and innovative approaches.
  • Seek personal and professional development opportunities, and share knowledge gained

Education, Qualifications, Skills and Experience

Essential

• Life science degree (MD, PharmD, RPh, RN, or related degree) or master’s degree in life sciences, or related field
• Extensive experience in patient safety/pharmacovigilance including applicable industry experience and seen as a subject matter expert
• Extensive operational experience in production of core safety outputs
• Good knowledge and comprehension of relevant pharmacovigilance legislation
• Excellent medical writing skills
• Excellent communication skills
• Experience and ability to develop and implement new standards and best practices
• Project management skills
• Proven ability to lead teams and collaborate in a continuous improvement
• Strategic thinking capability
• Good knowledge of the AZ organization
  

Desirable

• Regulatory strategy knowledge and experience
• Clinical development knowledge and experience
• Lean Sigma experience