About The Role Sandoz is going through an exciting and ground-breaking period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an enticing time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us as a Founder of our 'new' Sandoz! Job Purpose: Support the management of Patient Safety activities in the Sandoz affiliate, to ensure that operational processes are compliant and driven reliably in the context of the Sandoz Pharmacovigilance System, patient safety operating model, and associated quality system. Support the Manager Country Patient Safety in leading patient safety activities in the Sandoz affiliate, in Influencing the affiliate organization to promote a thorough understanding of the pharmacovigilance system and adherence to safety requirements for local activities Ensuring the flawless flow of safety relevant information, within the affiliate, with local business partners and with regional hubs and 3rd party vendors Maintaining oversight on safety profiles of Sandoz products and provide safety expertise and support for all marketed and investigational products Participate in oversight mechanisms on safety activities, specifically those outsourced to vendors on behalf of the affiliate Participate in the maintenance of the local quality management system, including training, records management, regulatory intelligence, audit and inspection readiness Act as deputy for the Manager Country Patient Safety and operate on their behalf for delegated activities or in case of absence. Act as SME for assigned subject areas for interactions within the affiliate and at audits and inspections. Your Key Responsibilities: Management of Safety Information Management of Adverse Events: Ensure the local management of AE information, with in collaboration with external partners: Identification of sources of adverse event information and implement reporting modalities from any sources in the country Ensuring case processing (triage/documentation; translation; follow-up activities, reconciliation and archive, as applicable) Ensuring expedited ICSR reporting to regulators and other recipients b. Product Complaints management: Ensure exchange and reconciliation of product complaints associated with adverse events. c. Management of Periodic reports: Chip in to the planning of periodic reports to meet local compliance obligations, submit reports authored by global functions. d. Management of Local Literature: In collaboration with external vendor, identify the local journals required for screening. e. Risk Management: Take part in the implementation of local RMP commitefficiencyectiveness checks. QMS and supporting processes Local Procedures: Take part in the development, update and implementation of local procedures to supplement PS global procedures and to ensure compliance national requirements, where required. b. Trainings: Take part in the preparation of Patient Safety training materials and the organization of these trainings in the affiliate, including preparation of confirmations and certificates. c. Records management: Ensure archiving and access to all records are maintained to lead all aspects of the safety information at local level. d. Compliance Management: Create critical metric reports and participate in compliance governance to lead all aspects of compliance, participate in investigation of root causes and creation of corrective/preventative actions for any non-compliance. e. Audits and Inspections: Participate in audit/inspection readiness. f. Deviation and CAPA: Document local deviations and participate in the implementation of any corrective/ preventative action. g. PSMF/PSSF: Assist in the maintenance of the PSMF/PSSF as per local requirements h. PV Agreements: Management and distribution of vigilance clauses to other departments (such as Legal, Procurement, etc.) to be included in local agreements and provide advice the owners of local contracts/ agreements with impact in the vigilance system, about the vigilance provisions to be included i. BCP: Participate in the implementation and testing of local BCP plans j. IT systems: Maintain awareness of local IT systems relevant for patient safety Other agreed tasks assigned by manager Other ad hoc activities appropriate for the role and experience. Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Role Requirements What you'll bring to the role Education (minimum/desirable): Health Care Sciences Professional (e.g., Medical Doctor, Nurse, Pharmacist) or equivalent education, training, and experience. Languages: Proficient in written and spoken English. Proficient in written and spoken local language. Experience/Professional Requirement: Ideally 2 years' experience in drug-safety or pharmacovigilance and/ or experience in pharmaceutical industry Knowledge of national and international regulations for pharmacovigilance Knowledge of pharmacological and medical terminology Good communication and interpersonal skills Quality and results oriented Project management skills Computer skills You'll receive: Breakdown of benefits received in this role. Include flexible working, learning and development opportunities as well. Why Sandoz Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more! With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably. Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged! The future is ours to shape! Division SANDOZ Business Unit NON-NVS TSA SANDOZ GLOBAL DEVELOPMENT Work Location Hyderabad, AP Company/Legal Entity Sdz Pvt Ind Functional Area Research & Development Job Type Full Time Employment Type Regular Shift Work No Early Talent No