Local Case Intake Team Leader

Local Case Intake Team Leader -Global Business Services

📍 Location: Guadalajara

📌Strong English & Portuguese communication skills required.

📌Must Submit Resume in English

📌 Positions are open to Mexican Citizens and official residents of Mexico.

About the AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development, and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. 

At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity. 

At AstraZeneca we:

• Believe in lifelong learning.
• Endeavor to be a great place to work.
• Encourage a “speak up” culture.
• Lead the way in sustainable IT & social impact.
• Actively work towards becoming a digital organization.

About The 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.

The Local Case Intake Team Manager will manage the team responsible for local case intake activities for designated MCs and/or Regions as determined by the GBS PV Strategy and Operating Model:

• 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
• Participate 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  

The Local Case Intake Team Leader will be accountable for:

• Maintain in-depth knowledge of the local health authority regulations and update regional lead & local teams with any new changes in legislation/guidance for discussion and escalation to relevant stakeholders in global Patient Safety as required.
• Ensure that local procedural documents/ standard operating procedures are followed for reporting/processing/ translation of AEs and are up to date & available for any patient safety audit and inspection.
• Ensure local information relating to pharmacovigilance activities is reflected correctly in the Pharmacovigilance System Master File (PSMF)
• Maintain oversight of all patient safety-related processes within the appropriate Regions and/or MCs
• Maintain current knowledge of the marketed status of products in the local country and reference documents (such as Product Information/Datasheet)
• Support full and prompt response to any patient safety query from the local regulatory authority related to patient safety function as determined by GBS and AstraZenece agreed KPIs and SLAs.
• Facilitate the necessary quality, including correctness and completeness, of PV data submitted to the local regulatory authority.
• Support local safety management agreements and clinical study protocols to fulfil AstraZeneca and local regulatory safety reporting requirements.
• Ensure cross-function collaboration through sharing patient safety knowledge with the local MC teams (e.g., Marketing, Sales, Regulatory Affairs, Medical Affairs)
• Ensure timely submission of ICSR, follow-up cases, and other safety documents to local health authorities.
• Oversee Health Authority interactions and queries, such as for ICSR-related products, related safety concerns, and educational materials associated with the Risk Management Plan (RMP)
• Ensure corrective and preventative actions are taken in the event of local non-compliance or breach of agreed SLAs.
• Support assessment of all non-serious AEs from spontaneous sources and the upgrade of relevant events to serious in accordance with the AstraZeneca Always Serious List.
• Support review of medical and scientific literature to identify possible Adverse events in accordance with AstraZeneca and local regulatory pharmacovigilance requirements.
• Establish strong relationships and effective cross-function collaboration with regulatory, marketing, medical, and other internal and external stakeholders’ functions to deliver patient safety requirements for business and regulatory needs.
• Ensure that the local case intake team completes all required patient safety training, global PS systems (e.g. Argus) and adheres to internal processes and external regulations.  Act as a mentor to support newly appointed Case Intake Advisors
• Ensure an after-hours process is in place and maintained, to ensure a customer can report an AE and respond to regulatory authority questions.
• Oversee filing and archiving practices of patient safety documents.
• Manage patient safety compliance data for the case intake team is up-to-date (e.g. monthly)
• Ensure appropriate Local Case Intake Advisor cover is in place so that all activities continue to be performed within the required timeframes when out of the office, on holiday, unexpected leave etc.  
• Support patient safety projects at local & global levels    

Requirements

Essential

• 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

• 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

(Hybrid - Expectation of working in the office 3 days a week)
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility.

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together.

Interested? Come and join our journey.

So, what’s next!

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

Where can I find out more?

Our Social Media:

Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

AstraZeneca is an equal opportunity employer.

AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.