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