Clinical Safety Coordinator

Medpace; São Paulo; Presencial; BRL 60.000 - 100.000; Tempo integral

Resumo da oferta

An established industry player is seeking a Clinical Safety Coordinator to join their growing Latin American team. This full-time role involves overseeing safety report submissions and collaborating with various departments to ensure compliance with regulatory timelines. The ideal candidate will have a strong background in drug safety and a keen attention to detail. Join a forward-thinking organization that values purpose and passion, and make a difference in the lives of patients and families facing health challenges. This opportunity not only offers a chance to grow your career but also to contribute to meaningful work in the clinical research field.

Serviços

Hybrid work-from-home options

Competitive PTO packages

Company-sponsored employee appreciation events

Employee health and wellness initiatives

Flexible work schedule

Competitive compensation and benefits package

Structured career paths with opportunities for professional growth

Qualificações

• Bachelor's degree in Life Science area required.
• 2-3 years of experience in drug safety preferred.

Responsabilidades

• Oversight of safety reports submission to authorities.
• Draft study specific safety documents as required.
• Work globally to distribute safety reports.

Conhecimentos

Attention to detail

Knowledge of Good Clinical Practice (GCP)

Medical terminology

Safety reporting to regulatory authorities

Experience in drug safety

Formação académica

Bachelor's degree in Life Science

Ferramentas

Electronic Data Capture (EDC) systems

Clinical databases

Descrição da oferta de emprego

Job Summary

Our Latin American activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Safety Coordinator to join our team! This position plays a key role in the pharmacovigilance process at Medpace. Working in a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

Responsibilities

1. Oversight of submission of safety reports in the appropriate format to Competent Authorities/Ethics Committees in compliance with regulatory timelines;
2. Regular interaction with other internal departments globally and locally, such as Clinical Operations, Data Management, and Regulatory Submissions;
3. Draft study specific safety documents as required;
4. Work in a global team to distribute safety reports globally.

Qualifications

1. Bachelor's degree in Life Science area required;
2. 2-3 years of experience of working within drug safety preferred;
3. Demonstrate fundamental knowledge of Good Clinical Practice (GCP) guidelines and medical terminology;
4. Knowledge of Electronic Data Capture (EDC) systems and other clinical databases;
5. Experience safety reporting to regulatory authorities in Spanish speaking LATAM countries;
6. Knowledge of applicable safety reporting guidelines;
7. Strong attention to detail.

Medpace Overview

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral, and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.

Why Medpace?

People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

Medpace Perks

• Hybrid work-from-home options (dependent upon position and level)
• Competitive PTO packages
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives
• Flexible work schedule
• Competitive compensation and benefits package
• Structured career paths with opportunities for professional growth

Awards

• Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023, and 2024
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What to Expect Next

A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

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