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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. Entrepreneurial organization in constant evolution With our innovative spirit, we use all our know-how, resources and human capital to develop solutions that meet patients’ unsatisfied needs. Our endeavour to find new therapeutic alternatives had led us to join forces with other leading pharmaceutical companies that share our enthusiasm and to establish alliances in order to progress together in healthcare.

Ready to be a #Challenger?

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.
• Life and accident insurance.
• On-site medical service
• Benefits and Savings Club.
• Training and language learning platform
• Wellness platform with unlimited free psychologist sessions
• Cabify transportation service for employee use
• Development plans, internal mobility policy.

What will the Selection process be like? ️

Stay tuned to your phone and email! The first thing we will likely do is contact you through one of the two channels.

Prepare well! We will continue with an in-person / virtual interview depending on availability and what we agree upon; there may be one or two interviews in the process, and depending on the type of process, there may also be some kind of test.

Wait for the result! We care that you feel guided throughout each selection process and know what to expect from us, so we will always try to inform you of the status of the process.

Do you think this offer is not for you?

Follow us on social media like LinkedIn / Instagram and stay tuned for any offers we may release; the opportunity to be a new Insuder is waiting!

COMMITMENT TO EQUAL OPPORTUNITIES

The InsudPharma group is aware that business management must align with the needs and demands of society, and therefore assumes the commitment to equal opportunities and treatment between men and women, as stated in the current regulations on the matter - Organic Law 3 / 2007, and we do not discriminate against any person on the grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.

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