Patient Safety Case Intake Advisor - Global Business Services (English)

📌Positions are open to Mexican Citizens and official residents of Mexico.
📍Location: Guadalajara (hybrid)
📌Strong English skills required

Must Submit Resume in English

About the AstraZeneca

AstraZeneca is a global biopharmaceutical business that concentrates on discovering, developing, and commercializing 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 an outstanding workplace culture that encourages innovation and collaboration. Here, employees are empowered to express different perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.

About The role

The Patient Safety Case Intake Advisor is responsible for handling 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 Patient Safety Case Intake Advisor will be proficient in English.

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 subject area, including procedural document management, implementation of AE/PV training requirements across internal personnel and third-party suppliershandlingng quality incident reporting, and audit & inspection readiness
• Chipping in 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 mentorship 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, supervising 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 Patient Safety Case Intake Advisor should:

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

The Local Case Intake Team Leader 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 mentorship 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 vital for AE complaint reporting.
  • Timely 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 chip in 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.
  

Requirements

• Degree or equivalent experience Qualified – Pharmacy/ Medical/ Science
• Pharmacovigilance knowledge
• 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

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 daring - 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 groundbreaking methods and bringing unexpected teams together.

So, what’s next!

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

Where can I find out more?

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 parental 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.

Expectation of working in the office 3 days a week statement

When we put unexpected teams in the same room, we ignite daring 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.

Join us in our outstanding and bold world!!!