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Descripción del trabajo
In a few words
Position : Drug Safety Specialist for CT Operations
Location : Madrid.
Experience : +3 years.
Want to know more?
Exeltis is an organization committed to innovation, excellence and healthcare. Our aim is to become a point of reference in the pharmaceutical sector. A step forward in improving health. Exeltis is the result of the natural evolution and sustained growth of Insud Pharma, an integrated health sciences group. It combines the Group’s know-how and experience with the innovative spirit of Exeltis, becoming a global organization with the capacity to discover, develop, produce, and market medicinal products and medical devices that can help to improve the quality of life of millions of people worldwide. Human wellbeing and health: our driving force. People are our core concern and guiding force. To provide better therapeutic solutions and reach more people worldwide, Exeltis has expanded its operations globally, giving even more patients rapid and effective access to our wide range of products. An entrepreneurial organization in constant evolution. With our innovative spirit, we leverage all our resources and human capital to develop solutions that meet patients’ unmet needs. Our efforts to find new therapeutic alternatives have led us to join forces with other leading pharmaceutical companies and establish alliances to advance healthcare together.
Ready to be a #Challenger?
What are we looking for?
The Exeltis Pharmacovigilance team is seeking an experienced Drug Safety Specialist to lead global operational pharmacovigilance support for our R&D development candidates and marketed products. The role involves timely reporting of adverse events from clinical trials to health authorities, ethics committees, and investigators.
Ideal candidates have experience in clinical trials and clinical operations (CRA, CRC, or CTM) within R&D or pharmacovigilance, especially supporting late-phase trials.
This position is based at our Pharmacovigilance headquarters in Madrid.
The challenge!
* Monitoring safety in phase I, II, III clinical trials.
* Reporting SAEs / SUSARs to authorities, ethics committees, and investigators.
* Providing guidance to study teams and CROs, and assisting with audits.
* Reviewing protocols and investigating safety risks.
* Developing safety protocols and procedures.
* Monitoring participant safety and compliance.
* Identifying and reporting safety signals.
* Developing DSUR reports.
* Analyzing safety data for changes in profiles.
* Assisting with patient information and consent forms.
* Liaising with regulatory agencies.
* Advising on safety-related study design issues.
* Monitoring safety protocol effectiveness.
* Ensuring PV activities compliance and maintaining accurate files.
What do you need?
* Degree in Science or Medicine.
* Fluent in English, both spoken and written.
* 3-5 years’ experience in clinical trial operations and safety reporting.
* Knowledge of GCP and GVP regulations.
* Minimal travel required.
* Entrepreneurial, analytical, adaptable, responsible, sociable.
Our benefits!
* Flexible start time, full-time.
* Permanent contract.
* Attractive salary package.
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