Barcelona, Catalonia, Spain
Experienced
Establishing and driving Patient Safety (PS) strategy and operational excellence at country level, in compliance with the national and international regulations/standards/guidelines and corporate procedures, for all marketed and investigational products - drugs and medical devices - under the responsibility of all Novartis companies and divisions. Leading the local PS department, ensuring the oversight of the quality management system for the PV system at local level, in collaboration with the local leadership and local/regional Quality Assurance (QA) function.
Establishing and driving patient safety strategy and operational excellence at the cluster level. Acting as a role model in terms of operational excellence, leadership, and stakeholder and people management at the cluster level in complex clusters with high regulatory impact and demanding health authorities.
• Ensuring collection, reporting and handling of safety information associated with Roche products according to global Roche and local regulatory requirements within the assigned PV Hub coverage areas. • Supporting and acting as a deputy PV Hub Manager • Technically and functionally leading the staff of the PV Hub • Managing daily workload of Hub unit within the department with line management responsibilities • Liaising with PV Hub manager with regard to resources, timelines and issues with quality, reorganizing daily workload based on priority, proactively communicating to management new issues, offering solutions and reporting availability to take on new assignments • Training new staff and mentoring less experienced members of the team
Main responsibilities: - Structured entry of serious and non-serious adverse events onto Client’s global PV safety database according to Client’s User Manual. - Extraction of relevant information from routine source documents and/or information coming from the Client affiliates via the LAM or from E2B messages - Preliminary evaluation and assessment of case reports for seriousness, global listedness and causality of all serious and non-serious adverse events - Accurate and timely AE/SAE data entry taking into account the automated case prioritization by Client’s global PV database and timely processing of action items considering the system-generated due dates for completion. - Creation of comprehensive case descriptions (narratives) in English language extracting relevant PV information from routine source documents - Checking of incoming PV information for consistency and completeness - Requisition of clarifications and additional PV information from Bayer affiliates and/or subcontractors within set timelines, as detailed in Client’s global SOPs - Verification of the accuracy of MedDRA and WHO-DD coding of reported adverse events, concomitant drugs
Bioanalytical Group, Analytical Development Department Main responsibilities: - Development of new analytical methods for biosimilar monoclonal antibody characterization - Supporting formulation development of new biosimilar products - providing drug product stability data and analytical background - Introduction of new analytical methods
Main responsibilities: • Servicing of manual and automated spectroscopic instruments around the world • Promoting new accessories for spectroscopic equipment, service contracts, spare parts and custom-tailored support plans • Providing technical back up as required via emails or phone calls • On site trainings for the new or already existing customers • Writing and updating of technical documents
- Lead a team in Drug Safety offering Pharmacovigilance services to a Client delivering a high quality data in stipulated timelines - Overall in-charge of day-to-day activities for team in Pharmacovigilance/Drug Safety - Involve in direct reportees development in identifying training needs - Oversight of direct reportees activities, leave management and conduct regular team meetings - Perform tasks/activities as communicated by the Project Leader - Escalation of identified unresolved issues to project leader and manager on time and ensure issue resolution in a timely manner - Interactions and telecons - Coordinate and communicate effectively with primary contacts at Client teams to ensure satisfactory progress of project work and timely resolution of issues
• Supporting PV activities within the hub coverage area to ensure PV activities are completed consistently in a timely manner • Guiding PV associates during daily activities including quality review • ICSR case processing, depending on workload • Interaction with primary contacts within the hub coverage area and global Roche community