Safety-Focused Drug Trials Professional

We are seeking a highly skilled Drug Safety Specialist to join our team.

The successful candidate will be responsible for leading global operational pharmacovigilance support for our R&D development candidates and marketed products.

This is an exciting opportunity for an experienced professional to take on a critical role in ensuring the safety of our products and contributing to the success of our organization.

Responsibilities

• 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.

Requirements

Selection Process

The selection process will involve a series of interviews and assessments designed to evaluate your skills, experience, and fit for the role.

During the process, you will have the opportunity to ask questions and learn more about our organization and the position.

We are committed to making the selection process fair, transparent, and accessible to all candidates.

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