Senior Pharmacovigilance Specialist

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VIATRIS ARABIA LIMITED "LLC" Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. We have been included on number of award lists that demonstrate the impact we are making. Primary Job Function: Primary role as local QPPV for Viatris in KSA. As Affiliate Safety Representative (ASR), accountable for the execution, maintenance, and continuous improvement of the Pharmacovigilance (PV) system for Viatris in Saudi Arabia (including legal entities under Viatris). To ensure adherence to established local and Viatris Global processes and guidelines, adhering to national and international regulations and guidelines for pharmacovigilance. Follow up and lead implementation of PV requirements within distributers dealing with Viatris in the region, to assure they meet Viatris required qualifications, through executing training programs and scheduled follow ups Core Job Responsibilities: ASR and Local QPPV As ASR and local QPPV, is responsible to organize, implement, and maintain the Affiliate PV System. After -Hours Availability Ensure after-hours availability as per local regulation. ICSR handling Ensures that local processes, procedures, and systems are in place for Individual Case Safety Report (ICSR) management including receipt, documentation, forwarding to relevant global team, tracking, follow up etc. Ensure collection of safety data and other PV-related responsibilities in relation to interventional studies (clinical trials) Ensure collection of safety data and fulfillment of other PV-related responsibilities in relation to Company-initiated Epidemiological Programs (CEPs) including PSPs, MRPs, registries, non-interventional studies, etc." Ensures screening of Viatris-sponsored social media (web sites, web pages, blogs, vlogs, social networks, internet forums, chat rooms or health portals) for safety information is performed and reconciliation is in place as per required. Ensures screening of local medical or scientific literature and ensure proper translation if needed, for medical/ scientific journals are not included in global literature review. Ensures that patient confidentiality and privacy in accordance with local applicable laws and regulations are adhered to. Ensures handling of safety information including adverse event reports, product quality complaints (PQCs), and safety communications, received from internal teams, healthcare professionals, regulatory authorities, or other relevant sources. Periodic Safety Reporting Inform relevant global team about the requirement/ change in requirement of any Periodic Safety Update Report (PSUR) in liaison with local regulatory affairs. Provides safety information required for scheduling and preparation of periodic safety report, upon request to relevant global team . Compliance Monitors Affiliate PV system performance and compliance. Reports monthly compliance metrics to relevant global team . Maintains awareness of local PV legislation and of relevant international legislations, regulations, and guidelines. Ensures tracking and communicating changes in local PV regulations that may have an impact on global standards and procedures. Maintains compliance with local agreements, including reconciliation and safety data exchange between partner companies. Completes monthly ICSR reconciliation with regional stakeholders, including medical information and product complaints. Ensures deviation procedure is in place to document necessary planned deviations from procedures and to be used when managing non-conformities arising from product complaints (in association with QA). Training Maintains a version-controlled training matrix for local PV personnel. Ensures basic PV training of new Affiliate employees and refresher training at least annually and that appropriate training records are maintained. Ensures training on and compliance with global and local SOPs, and relevant regulations and legislations. Ensure that any training of partner company staff is completed according to local contract requirements and appropriately documented. Creates PV training material where applicable and approves PV Training material authored by others. SOPs Ensure implementation of PV standards and procedures, as applicable. Ensures local processes and procedures are developed and implemented to define PV responsibilities in line with global standards and procedures, as weIl as local regulations, as applicable. Audits and Inspections Be the key Affiliate contact for both internal PV audits and reg

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