PATIENT SAFETY CASE INTAKE ADVISOR - GLOBAL BUSINESS SERVICES (ENGLISH & CANADIAN FRENCH)

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

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

ABOUT THE ROLE

The 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 Local Case Intake Advisor will be proficient in English and Canadian French.

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 suppliers, handling 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 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 Things we value 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 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.
• Maintain current and in-depth knowledge of:
• Relevant country regulatory authority regulations
• Global and local procedural and mentorship 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