Drug Safety Specialist

Exeltis; Madrid; Presencial; EUR 40.000 - 80.000; Jornada completa

Descripción de la vacante

An established industry player is seeking a dedicated Drug Safety Specialist to enhance its pharmacovigilance efforts. In this pivotal role, you will oversee the safety monitoring of clinical trials, ensuring compliance with regulations while collaborating with clinical operation teams. Your expertise will contribute to the development of safety protocols and the timely reporting of adverse events, ultimately improving health outcomes for patients. Join a forward-thinking organization committed to innovation and excellence in healthcare, where your contributions will make a significant impact on global health solutions.

Servicios

Flexible Start Time

Permanent Contract

Attractive Salary Package

Formación

• 3-5 years in clinical trial operations and safety reporting.
• Fluent in English, both verbally and in writing.

Responsabilidades

• Lead global pharmacovigilance support for R&D candidates.
• Monitor safety of clinical trial participants and ensure compliance.
• Develop safety protocols and procedures for clinical research.

Conocimientos

Clinical Trial Operations

Safety Reporting

Analytical Skills

Adaptability

Entrepreneurial Spirit

Educación

Pharmacy Degree

Biochemistry Degree

Biology Degree

Medical Degree

Descripción del empleo

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. In order to provide better therapeutic solutions and reach more people worldwide, Exeltis has taken its operations to every continent, giving even more patients rapid and effective access to our wide range of products.

What are we looking for?

The Exeltis Pharmacovigilance team is actively seeking an experienced Drug Safety Specialist to lead global operational pharmacovigilance support for our R&D development candidates and marketed products. In this critical role, the candidate will be responsible for the timely reporting of adverse events from clinical trials to health authorities, ethics committees, and clinical trial investigators.

Our ideal candidate is passionate about clinical trials and possesses prior experience in clinical operations (such as CRA, CRC, or CTM) within a research-focused R&D or pharmacovigilance department. A proven track record in supporting late-phase clinical trial activities is essential.

This position is located at our Pharmacovigilance headquarters in Madrid.

The challenge!

• Safety monitoring of interventional phase I, II, III clinical trial activities.
• Safety reporting of SAEs / SUSARs to health authorities, ethics committees, and clinical trial investigators.
• 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 trials.
• 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.

What do you need?

• Education : Science (e.g. Pharmacy, Biochemistry, Biology) or medical degree.
• Languages : Fluent in English provisional level verbally and in writing.
• Experience (years / area) : +3-5 years’ experience with clinical trial operations and safety reporting in a pre and post marketing setting.
• Specific Knowledge : Proficient knowledge of clinical trials regulations and safety reporting regulations under Good Clinical practise (GCP) and Good Pharmacovigilance Practise (GVP).
• Travels : Minimal travel activity is expected.
• Personal skills : Entrepreneurial, analytical skills, adaptability / flexibility, initiative, sociable, responsible.
• Flexible start time from Monday to Friday (full-time).
• Permanent contract.
• Attractive salary package.