Pharmacovigilance Technician
hace 1 semana
.Viatris Pharmaceuticals S.L. At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via : Access Providing high quality trusted medicines regardless of geography or circumstance; Leadership Advancing sustainable operations and innovative solutions to improve patient health; Partnership Leveraging our collective expertise to connect people to products and services. Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment. For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world. The Role & What You Will Be Doing Every day, we rise to the challenge to make a difference, and here's how the Pharmacovigilance (PV) Technician role will make an impact : The PV Technician is responsible for the maintenance and continuous improvement of the pharmacovigilance (PV) system at the PV Department at the Spanish affiliate. Perform, plan and assist in the day-to-day work at the PV department. Monitor PV mailbox and other communication channels for incoming ICSRs on drugs and parapharmaceuticals (medical devices, cosmetics and food supplements). ICSR management (for drugs, medical devices, cosmetics and food supplements) and CSR reconciliations with applicable stakeholders. Assist in review of PV SOPs and other department's SOPs for alignment. Directly involved in the continuous improvement work with regards to local PV procedures and tools; including writing localSOPs, work instructions and job aids. Actively participate in audits and inspections. Perform local quality and compliance (QC) work. Take corrective and preventive actions as needed including completion of deviation forms (PIFs), tracking and documentation. Support Corrective Action and Preventive Action (CAPA) plans and continuous improvement work within the PV area. Assist in Risk Management Plan activities and Direct Healthcare Professional Communications (DHPC). Identify, negotiate and establish the applicable pharmacovigilance agreements. Maintain them updated. Assist in CEP (Customer Engagement Program) activities, such as digital media, Market Research Programs and Patient Support Programs. Assist in local PSUR / ACO work. Responsible for being up to date with written procedures and current legal requirements and internal standards within the PV area of the products in scope