Local Case Intake Advisor

Local Case Intake Advisor -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 Case Intake Advisor is responsible for managing the intake, processing, and reporting of individual case safety reports (ICSRs) at the local level.  This role will support specific local Marketing Companies to ensure compliance with Astra Zeneca (AZ) and relevant national regulatory requirements, serving as the primary liaison point between those Marketing Companies and GBS-PS.

The Local Case Intake Advisor will be fluent in English and Portuguese.

Core responsibilities may include:

• Supporting Individual Case Safety Reports (ICSRs) processing and handling, including adverse event reporting from clinical and post-marketed sources for AstraZeneca products
• Supporting Health Authority interactions, such as for ICSR related queries
• Contribution to effective operational implementation of the Quality Management System appropriate to the GvP discipline, including procedural document management, implementation of AE/PV training requirements across internal personnel and third-party suppliers, managing quality incident reporting, and audit & inspection readiness
• Contributing to the PV aspects relating to Organised Data Collection Programmes, Digital and Social Media activities, and other arrangements with external parties (such as Licence Partners (LP), Externally Sponsored Research (ESR), ODCP providers, partnerships or other collaborations etc)
• Provide Patient Safety expertise and guidance within the local Marketing company (e.g., Marketing, Sales, Regulatory Affairs, Medical Affairs) related to issue management for key products, risk management, formulating action plan/implementation, information gathering/extracting data, monitoring results of actions plans, and provide safety data expertise
• Participating in ad-hoc local Marketing Company projects

•  Ensure conduct of PV and submission of all PV-related documents is in accordance with MC requirements and Good Pharmacovigilance Practice (GVP)

Additionally, the Case Intake Advisor should:

• Establish strong relationships and effective collaboration between regulatory, marketing, clinical and other internal and external stakeholders' functions to deliver patient safety requirements for business and regulatory needs
• Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to the role.

The Local Case Intake Advisor will be accountable for:

• Support provision of the following activities:
  • Pharmacovigilance activities including local processes, procedures and systems in place for collection, reporting and tracking of Adverse Events (AEs), handling of Individual Case Safety Reports (ICSRs) for AEs from clinical and post-marketed sources (including literature) and Organised Data Collection Programs.
  • Review, assessment and processing of safety data and information received from various sources, distributing reports and/or metrics onwards to both internal and external third parties following applicable regulations and standard operating procedures (SOPs), under guidance and support of the appropriate Local Case Intake Team Managers and/or senior team members.
  • Identification of Product Quality Complaint (PQC) and Product Security complaints, including collection of information necessary for AE complaint reporting.
  • Prompt support for responses to any queries from regulatory authorities related to the Patient Safety function.
  • Implementation of Corrective and Preventative Actions in the event of local non-compliance and processing of completed late logs.
  • Reconciliations ensuring the accuracy of pharmacovigilance data that is transferred and received.
  • Periodic screening of regulatory authority database for adverse events.
  • If required, perform literature search and related activities for MC product portfolio.
  • Undertake manual follow-up where required disseminating clear and accurate information based on approved call scripts and/or other AZ approved resources.
  • Filing and archiving practices of patient safety documents.
• Actively contribute to maintaining the core components of Good Pharmacovigilance Practice, via contribution to all safety related processes and brand activities within countries of remit and being audit and inspection ready.
• Support external service providers to meet the company and local regulatory PV requirements.
• Support the local PS team in relation to audits or regulatory authority inspections.
• Complete all required patient safety trainings in adherence to internal processes and external regulations, and obtain access to relevant systems, such as Safety Database, Regulatory systems, Human Resources systems, Quality Management Systems, and other global or local systems commercial databases as appropriate.
• Maintain current and in-depth knowledge of:
  • Relevant country regulatory authority regulations
  • Global and local procedural and guidance documents
  • Marketed status of products in the local country and reference documents (i.e. Core Data Sheet)
  • Conditions, obligations and other commitments relating to product safety or the safe use of AZ products

Requirements

Essential

• Degree Qualified – Pharmacy/ Medical/ Science
• Pharmacovigilance knowledge excellence
• Good Pharmacovigilance Practice
• Knowledge of health authority regulations
• Cross functional collaborative approach
• Effective and lateral thinking
• Problem solving
• Vendor management
• Excellent attention to detail
• Excellent written and verbal communication skills

Desirable

• Influencing, and Conflict Resolution skills.
• Medical knowledge in company Therapeutic Areas
• Project management
• Successful participation in above-market projects
• Audit & Inspection experience

(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.