Overview:The Exeltis Pharmacovigilance team is seeking an experienced Drug Safety Senior Specialist to Manage its global operational pharmacovigilance support for the Exeltis R&D development candidates and marketed products. The candidate will be responsible for data review, compilation and analysis including case management of reported adverse events in the Exeltis global safety database. The position is located in the PV HQ in Madrid.Responsibilities:Specific responsibilitiesPre-marketing responsibilities:- Safety monitoring of interventional phase I, II, III clinical trial- Provide recommendations and guidance to study clinical operation teams and Contract Research Organizations (CRO) personnel and assist in audit readiness and preparation.- Review clinical research protocols and investigate any potential safety risks associated with the study.- Develop safety protocols and procedures for clinical research studies.- Monitor the safety of clinical trial participants and ensure compliance with safety guidelines.- Identify and report any potential signal or safety issue that may arise during a clinical study.- Develop the development safety update report (DSUR) for clinical trials.- Analyse patient data to detect any changes in safety profiles.- Assist in the development of patient information materials and consent forms.- Liaise with regulatory agencies to ensure compliance with safety-related regulations.- Advise researchers on safety issues related to their study designs.- Monitor and evaluate the effectiveness of safety protocols during clinical trialsPost-marketing responsibilities:- Safety monitoring of post-authorization safety studies, market access and other types of phase IV activities.- Management of Adverse Events including activities such as processing spontaneous, regulatory and literature adverse event case reports and conducting follow-up.- Participation in the processes involving the collection, processing, review, and distribution of adverse event information regarding marketed Exeltis products.- Contribute to ensure compliance of pharmacovigilance activities including activities such as conduct case reconciliation with concerned departments, affiliates, distributors, or business partners.- Collaborate in the maintenance of the Quality PV system of Exeltis Organization, giving support in the elaboration, update, and implementation of Standard Operating Procedures (SOPs).- Collaborate in the continuous monitoring of the risk-benefit balance of products owned by Exeltis.- Keep PV files safe, accurate, updated, and complete, in compliance with internal standards and applicable regulations.Qualifications:Requirements- Education: Science (e.g. Pharmacy, Biochemistry, Biology) or medical degree.- Languages: Fluent in Spanish and a decent English provisional level verbally and in writing.- Experience (years/area): +5-7 years' experience with clinical trial operations and safety reporting in a pre and post marketing setting.- Specific Knowledge: Deep knowledge of the current European (GVPs) and UK PV Legislation. Knowledge and management of electronic PV databases. Deep knowledge of Clinical trials regulations.- Travels: Minimal travel activity is expected.- Personal skills: Entrepreneurial, analytical skills, adaptability/flexibility, initiative, sociable, responsible.
