Local Case Intake Team Manager, GBS Patient Safety

Location: Lisbon, Portugal

Strong English Communication Skills Required

Introduction to role:

The Local Case Intake Team Manager is responsible for overseeing the local case intake process for a specific group of local Marketing Companies, ensuring efficient and compliant handling of adverse event reports. This role requires strong leadership skills, in-depth knowledge of pharmacovigilance regulations, and the ability to manage a team in a fast-paced environment. You will lead the team responsible for local case intake activities for designated MCs and/or Regions as determined by the GBS PV Strategy and Operating Model.

Accountabilities:

• Leading and managing a local case intake team, providing guidance, training, and performance management to ensure high-quality standards in case processing.
• Overseeing the intake, processing, and reporting of Individual Case Safety Reports (ICSRs) in compliance with the appropriate pharmacovigilance regulations and AZ standards.
• Ensuring timely and accurate processing of information for all patient safety cases.
• Overseeing Health Authority interactions, ensuring that Local Case Intake Advisors are delivering this aspect of their role and acting as an escalation point where Health Authority interactions require more senior involvement.
• Monitoring and analysing local case intake metrics for the local case intake team, preparing reports on key performance indicators (KPIs) and identifying areas for improvement.
• Staying updated on changes to local and global pharmacovigilance regulations, ensuring consistency between global and local processes as well as implementing and maintaining standard operating procedures (SOPs) for the latter.
• Participating in audits and inspections, ensuring the local case intake process is audit-ready.
• Conducting quality checks on completed cases to verify accuracy, consistency, and compliance with all requirements.
• Serving as a liaison between local and global levels, communicating changes related to the local pharmacovigilance organisation.
• Participating in ad-hoc Global, Regional, or local MC case handling projects.
  
  
  

Essential Skills/Experience:

• Degree Qualified – Pharmacy/ Medical/ Science
• Thorough knowledge and experience of pharmacovigilance within the pharmaceutical industry
• Thorough knowledge of the current pharmacovigilance and regulatory developments
• Experience in working cross-functionally
• Ability to set and manage priorities, resource goals and project initiatives
• Ability to influence strategically to obtain desired outcomes while maintaining effective, positive organisational relationships
• Excellent attention to detail
• Excellent written and verbal communication skills
  
  
  

Desirable Skills/Experience:

• Degree Qualified – Pharmacy/ Medical/ Science
• Thorough knowledge and experience of pharmacovigilance within the pharmaceutical industry
• Thorough knowledge of the current pharmacovigilance and regulatory developments
• Experience in working cross-functionally
• Ability to set and manage priorities, resource goals and project initiatives
• Ability to influence strategically to obtain desired outcomes while maintaining effective, positive organisational relationships
  
  
  

At AstraZeneca, we are dedicated to discovering, developing, and commercialising prescription medicines that address some of the world's most serious diseases. We foster an environment built on innovation and creativity where questioning minds never settle until new insights are uncovered. Our commitment to making the right choices drives us to spot opportunities and develop resilience to solve complex challenges. We value diversity and believe that sharing different perspectives is key to unlocking our plans for industry-leading growth.

Join us in pushing the boundaries of science to deliver life-changing medicines. Apply now!