Senior Patient Safety Specialist (Karnataka)

About AstraZeneca AstraZeneca is a global science-led patient-focused biopharmaceutical company 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 Senior Specialist Global Patient Safety India Asia Frontier Role Profile Ability to manage high-level aspects of patient safety activities and processes at the country level in collaboration with internal and external stakeholders to ensure that local and global PV requirements are adhered to across the AstraZeneca portfolio Specialized in one or more processes within the PS safety team and provides oversight and expertise to the PS function Ability to manage PS systems databases activities and projects at the country level using patient safety knowledge and personal skills to run day-to-day PS work efficiently in compliance with local regulatory regulations and AstraZeneca requirements Ability to manage audits and local inspections and liaise cross-functionally to meet PS requirements Leadership skills and advanced PS knowledge are crucial for this role Has the functional knowledge to deliver high standards with increasing freedom to act without direct supervision The job holder is expected to manage risk and develop reporting tools and analysis processes to identify improvements Deliver a centrally managed provision of services such as documents systems management and solve complex problems within the patient safety area and participate in certain projects The Role holders is considered an expert in their field capable of providing technical guidance and will be expected to contribute to certain projects at a local level Accountabilities Responsibilities The Senior Specialist Global Patient Safety 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 The Core responsibilities may include Maintains in-depth knowledge of the local health authority regulations and updates regional lead local teams with any current changes in legislation guidance for discussion and escalation to relevant stakeholders in global Patient Safety as required Maintain local procedural documents related to patient safety activities are up to date Ensure local information relating to pharmacovigilance activities is reflected correctly in the Pharmacovigilance System Master File PSMF Maintain oversight of all safety-related processes issues and brand activities within their country including product risk management plans and associated activities Maintain up-to-date 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 guidance and working instructions Keep the 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 patient safety 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 portal VQV Nominated Signatory Portal Cover ERV Veeva CRM and 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 Ensure elements of Good Pharmacovigilance Practice are implemented at the local level Conduct activities and interactions consistent with AstraZeneca s values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to the role Managing Patient safety activities related to the processing and handling of Individual Case Safety Reports ICSRs and follow-up cases received from clinical and post-marketed sources for AstraZeneca products in addition to conducting Monthly quality control processes Ensure timely submission of ICSR follow-up cases and other safety documents PBRERs DSURs 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 Manage Health .