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.Establish strong relationships and effective collaboration between regulatory, marketing, medical, and other internal and external stakeholders, to deliver patient safety requirements for business and regulatory needs.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 readyMaintain current and in depth knowledge ofrelevant country health authority regulationsglobal and local procedural documents and guidancesmarketed status of products in the local country and reference documents (e.g. Core Data Sheet)conditions or obligations and other commitments relating to safety or the safe use of the products.Complete all required patient safety trainings, adhere to internal processes and external regulations, 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.Effective operational and 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.Support projects at local & global levels.Support external service providers to meet the company and local regulatory PV requirementsSupport provision of the following activities:local information relating to pharmacovigilance activities is reflected correctly in the Pharmacovigilance System Master File (PSMF)capture and escalate as appropriate changes in legislation/guidancecreation, implementation, and maintenance of local risk management plans and risk minimization activities to support regulatory submissions in collaboration with cross-functional teams.full and prompt response to any query from the local regulatory authority related to patient safety function.Health Authority interactions, such as for ICSR-related queries, product-related safety concerns, and activities associated with Risk Management Plan (RMP)local safety management agreements and clinical study protocols to fulfill The Company and local regulatory safety reporting requirementsmaintenance of local procedural documents related to patient safety activitiesdelivery of PS training to local staff and locally engaged vendors including annual refresher training.processing and handling of Individual Case Safety Reports (ICSRs), including adverse events from clinical and post-marketed sources (including Literature)

local processes, procedures, and systems are in place for reporting, collection, translation, processing, and reporting of clinical and post-marketed adverse events from all sources, and implementation of corrective and preventative actions are taken in the event of local non-complianceQuality (including correctness and completeness) and timely submission of PV data submitted to the local regulatory authority (for example ICSR and follow-up information, SUSARs, PBRERs, DSURs, Signals, RMPs, DHPCs, etc)reconciliations, ensuring the accuracy of pharmacovigilance data that is transferred & receivedmanagement of the PV aspects relating to Organised Data Collection Programmes, Digital and Social Media activities, and other arrangements with external parties (such as Externally Sponsored Research (ESR), health authorities’ partnerships, or other collaborations)management of local safety agreements and update relevant Pharmacovigilance Agreement Listings systemsmaintenance and testing of local Business Continuity Process (BCP)after-hours process, ensuring a customer can report an AE and respond to regulatory authority questionsfiling and archiving practices of patient safety documentsretention of up-to-date organization charts, job descriptions, training records, and curriculum vitae

Qualifications

Pharmacovigilance knowledge excellenceGood Pharmacovigilance PracticeKnowledge of health authority’s regulationsCross functional collaborative approachEffective and lateral thinkingProblem solvingVendor managementExcellent attention to detailExcellent written and verbal communication skills

Date Posted

30-Dec-2024

Closing Date

16-Mar-2025

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 authorization and employment eligibility verification requirements.