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Clinical Trials Specialist
2 semanas atrás
At TN Portugal, we are seeking a highly skilled Clinical Trials Specialist to join our team. This role is perfect for individuals who have a strong background in pharmacovigilance and case processing.
About the RoleThis is an exciting opportunity for you to work with us on various clinical trials projects. As a Clinical Trials Specialist, your primary responsibility will be to manage and process Individual Case Safety Reports (ICSRs) from all sources, including post-marketing and clinical trials.
You will work closely with our project teams to ensure that all contracted activities are completed in compliance with applicable regulations, company procedures, and client-specific requirements.
In this role, you will have the opportunity to develop and maintain relationships with colleagues across different departments and locations, fostering a collaborative and supportive working environment.
Key Responsibilities- Processing of ICSRs: You will be responsible for processing ICSRs from all sources, ensuring that they are compliant with applicable regulations and company procedures.
- SAE/SUSAR Management: You will manage submissions, unblinding, and clinical trial reconciliations for SAEs and SUSARs.
- Database Outputs: You will prepare database outputs for periodic reporting, such as PBRER, DSUR, and PADER.
- Mentoring and Training: You will mentor and train new employees within the department, focusing on procedure optimization and development.
- A degree in a life science or biomedical field, with a strong background in pharmacovigilance and case processing.
- Demonstrated experience in managing and processing ICSRs, as well as experience in SAE/SUSAR management.
- Excellent time and issue management skills, with the ability to multitask and prioritize tasks effectively.
- Strong interpersonal and communication skills, with the ability to build and maintain relationships with colleagues and clients.
- Advanced English language skills, both verbal and written.
We offer a dynamic and supportive working environment, with opportunities for professional growth and development. Our team is committed to delivering high-quality services to our clients, and we are looking for like-minded individuals to join us.
