Pharmacovigilance Regional Coordinator

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Diversity, Equity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world. When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough. At Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location. We are looking for a Pharmacovigilance Regional Coordinator based in São Paulo, Bogotá or Mexico City. Essential Job Duties and Responsibilities Patient Support Program (PSP) Pharmacovigilance interface o Support PSP PV interface, facilitating the implementation of processes improvement. o Participate on the review evaluation of new PSPs, new PSP benefits and PSP strategies/campaigns implementation, besides PSP closure, supporting adequate PV requirements accomplishment. o Liaise with the LSOs on PSP protocols/scripts updates. o Implement periodic meetings with PSP stakeholders aiming ensure proper visibility to PV Case Management team regarding any PSP activity that may cause processing impact. o Be responsible for insights and data generation, seeking to bring safety valuable data to PSP and the company business. Procedural and Regulatory Framework o Maintain proper oversight of internal procedures and regulatory requirements and ensure activities are conducted in accordance. o Liaise with the LSOs to ensure that any changes in local regulations are properly communicated, assessed and implemented with the PSPs. o Support LSOs on reconciliations when needed. o Maintain updated training program to the PSPs. o Support the maintenance of PSP PV controlled documents. Good Pharmacovigilance Practices and Inspection Readiness o Disseminate quality and compliance culture among the team and interface areas. o Ensure activities are conducted in accordance with Good Pharmacovigilance Practices. o Support PV Case Management Team in monitoring PV compliance metrics, implement corrective and preventive actions, when needed. Promptly escalate any non-conformance identified. o Support audits and inspections when required. Process improvement o Actively seek opportunities for process improvement and optimization; implement the changes as applicable. Regional and Global projects o Actively participate in regional and/or global project Pharmacovigilance related.