EndereçoAstraZeneca is one of the most fascinating biopharmaceutical companies in the world. From researchers to sales people, from lab technicians to the legal department, we all have a mission to turn ideas into science, science into revolutionary medicines that save and extend patients’ lives and benefit society. Our portfolio is solid and our pipeline is innovative with a focus on biological medicines in the Cardio-Metabolic, Respiratory and Oncology areas.
Patient Safety Senior Analyst
You will be responsible for:
● The Analyst, PS is accountable for maintaining local procedural documents related to Patient Safety activities are up to date.
● Maintain an 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 local information relating to pharmacovigilance activities is reflected correctly in the Pharmacovigilance System Master File (PSMF)
● Support all safety-related processes, issues, and brand activities within their country, including product risk management plans and associated activities.
● Maintain current knowledge of the marketed status of products in the local country and reference documents (such as Product Information/ core data sheet) in addition to maintaining up-to-date knowledge related to global Patient Safety procedures.
● Awareness of any conditions or obligations and other commitments relating to safety or the safe use of the products.
● Support the creation, implementation, and maintenance of local risk management plans and risk minimization activities to support regulatory submissions in collaboration with cross-functional teams.
● Support full and prompt response to any query from the local regulatory authority related to Patient Safety function.
● Facilitate the necessary quality, including correctness and completeness, of PV data submitted to the local regulatory authority.
● Fully trained on different global PS systems (Argus, JASPER, Orbit, My time and VQV, Nominated Signatory Portal, Cover, ERV, Veeva CRM, ECMS.)
● Support local safety management agreements and clinical study protocols to fulfill AstraZeneca and local regulatory safety reporting requirements.
● Support AstraZeneca’s external Patient Safety service provider to meet AstraZeneca and local regulatory pharmacovigilance requirements.
● Ensure cross-function collaboration through sharing Patient Safety knowledge with the local MC teams (e.g., Marketing, Sales, Regulatory Affairs, Medical Affairs)
● Support implementation of the elements of Good Pharmacovigilance Practice at the local level.
● 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.
● Contributes to the core components of the local pharmacovigilance system, by ensuring AZ has in place an effective pharmacovigilance system that complies with the local PV requirements.
● Supporting Patient safety activities related to the processing and handling of Individual Case Safety Reports (ICSRs), including adverse event reporting from clinical and post-marketed sources for AstraZeneca products.
● Ensure timely submission of ICSR, follow-up AE cases, and other safety documents (PBRERs, Signals, SUSARs, RMPs, DHPCs, etc) to local health authorities. ● Annual update and testing of local Business Continuity Process (BCP)
● Support delivery of PS training to local staff and locally engaged vendors including annual refresher training.
● Supporting Health Authority interactions, such as for ICSR-related queries, product-related safety concerns, and activities associated with risk Management Plan (RMP)
● Ensure collection, processing, and reporting of clinical and post-marketed adverse events from all sources.
● Ensures corrective and preventative actions are taken in the event of local non-compliance.
● Ensure local processes are in place and up to date to be ready for PS audit and inspection.
● Support assessment of all non-serious AEs from spontaneous sources and the upgrade of relevant events to serious in accordance with the AstraZeneca Always Serious List.
● Support review of medical and scientific literature to identify possible Adverse events in accordance with AstraZeneca and local regulatory pharmacovigilance requirements.
● Contribute to the 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 management 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)
● Support Patient Safety projects at local & global levels.
● Ensure submission of all PV-related documents on time as per the local health authority’s requirements and Good Pharmacovigilance Practice
● Establish strong relationships and effective collaboration between regulatory, marketing, medical, and other internal and external stakeholders’ functions to deliver Patient Safety requirements for business and regulatory needs.
● Complete all required Patient Safety training and adhere to internal processes and external regulations.
● Support management of local safety agreements and update Pharmacovigilance Agreement Listings (PAL)
● Support the reconciliation process to ensure the accuracy of pharmacovigilance data that is transferred & received.
● Ensure an after-hours process is in place, to ensure a customer can report an AE and respond to regulatory authority questions.
● Supports filing and archiving practices of Patient Safety documents.
● Ensure local processes, procedures, and systems are in place for reporting, processing, and translation of AEs from spontaneous and solicited sources.
● Ensure up-to-date organization charts, job descriptions, training records, and curriculum vitae are available.
You will need to have:
● Bachelor’s level degree required;
● Advanced/fluent english;
● Experience with pharmacovigilance process;
● Argus knowledge is desirable.
AstraZeneca is an equal opportunity employer and will consider all applicants qualified for their positions without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave, race or national or ethnic origin, age, religion or belief, identity gender, marital status, protected veteran status (if applicable), or any other feature protected by law. AstraZeneca only employs individuals with the right to work in the country (ies) where the vacancy 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 authorization and employment eligibility verification requirements.
