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 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 astrazeneca (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 productssupporting health authority interactions, such as for icsr related queriescontribution 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 readinesscontributing 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 expertiseparticipating in ad-hoc local marketing company projectsensure 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 needsconduct 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 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 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 regulationsglobal and local procedural and guidance documentsmarketed 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 productsrequirements essential degree qualified – pharmacy/ medical/ sciencepharmacovigilance knowledge excellencegood pharmacovigilance practiceknowledge of health authority regulationscross functional collaborative approacheffective and lateral thinkingproblem solvingvendor managementexcellent attention to detailexcellent written and verbal communication skillsdesirable influencing, and conflict resolution skills.medical knowledge in company therapeutic areasproject managementsuccessful participation in above-market projectsaudit & 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 gives 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 astrazeneca on facebook astrazeneca on instagram 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.
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