DRUG SAFETY SENIOR SPECIALIST

Who we are?Exeltis is a leader in the field of #Women's Health. It researches, innovates and creates new treatments and devices to improve the health and wellbeing of women all over the world. With a global footprint spanning more than 40 countries, Exeltis has a team of over 4,000 professionals and a global manufacturing network. Exeltis has one overarching goal: to offer women support and care throughout every single stage of their lives.About the roleThe 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.Specific responsibilitiesPre-marketing responsibilities:Monitoring of interventional phase I, II, III clinical trial activities.Recommendations and guidance to study clinical operation teams and Contract Research Organizations (CRO) personnel and assist in audit readiness and preparation.clinical research protocols and investigate any potential safety risks associated with the study.Safety protocols and procedures for clinical research studies.The safety of clinical trial participants and ensure compliance with safety guidelines. and report any potential signal or safety issue that may arise during a clinical study.The development safety update report (DSUR) for clinical trials patient data to detect any changes in safety profiles.In the development of patient information materials and consent forms.With regulatory agencies to ensure compliance with safety-related regulations.Researchers on safety issues related to their study designs and evaluate the effectiveness of safety protocols during clinical trialsPost-marketing responsibilities:Monitoring of post-authorization safety studies, market access and other types of phase IV activities of Adverse Events including activities such as processing spontaneous, regulatory and literature adverse event case reports and conducting follow-up.In the processes involving the collection, processing, review, and distribution of adverse event information regarding marketed Exeltis products.To ensure compliance of pharmacovigilance activities including activities such as conduct case reconciliation with concerned departments, affiliates, distributors, or business partners.In the maintenance of the Quality PV system of Exeltis Organization, giving support in the elaboration, update, and implementation of Standard Operating Procedures (SOPs).In the continuous monitoring of the risk-benefit balance of products owned by Exeltis.PV files safe, accurate, updated, and complete, in compliance with internal standards and applicable regulations.Requirements and Personal SkillsScience (e.g. Pharmacy, Biochemistry, Biology) or medical degree.Fluent in Spanish and English verbally and in writing.(Years/area):+5-7 years’ experience with clinical trial operations and safety reporting in a pre and post marketing setting.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.Minimal travel activity is expected.Soft skills:Entrepreneurial, analytical skills, adaptability/flexibility, initiative, sociable, responsible.WHY YOU SHOULD JOIN EXELTIS ?It´s a company people can’t get enough of. Its pace, its projects, its mission, its vision, its culture and its people will have you hooked. And there’s space for everyone. A wealth of different nationalities, an endless array of profiles, styles, ages, experience levels, and we’re all rowing in the same direction.