Experienced Clinical Safety Coordinator (Drug Safety)

Medpace; Buenos Aires; On-site; BRL 264,270 - 369,978; Full time

Benefits offered by this job

Flexible work environment

Competitive compensation and benefits package

Competitive PTO packages

Structured career paths

Employee health and wellness initiatives

Job summary

A leading clinical research organization in Brazil is seeking a Clinical Safety Coordinator to oversee safety report submissions and interact with internal departments. This role requires a Bachelor’s degree in life science, 3 years of drug safety experience, and fluency in Spanish and English. The coordinator will play a crucial role in pharmacovigilance processes and enjoy a flexible work environment with competitive benefits.

Qualifications

• Bachelor's degree in life science area is required.
• Demonstrate fundamental knowledge of Good Clinical Practice (GCP) guidelines.
• 3 years of experience working in drug safety and experience safety reporting.

Responsibilities

• Oversight of submission of safety reports in compliance with regulatory timelines.
• Regular interaction with various internal departments globally.
• Draft study-specific safety documents as required.

Skills

Knowledge of Good Clinical Practice (GCP)

Fluency in Spanish & English

Attention to detail

Experience in drug safety

Education

Bachelor's degree in life science

Tools

Electronic Data Capture (EDC) systems

Job description

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

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

Qualifications

• Bachelor's degree in life science area is required;
• Demonstrate fundamental knowledge of Good Clinical Practice (GCP) guidelines and medical terminology;
• Knowledge of Electronic Data Capture (EDC) systems and other clinical databases;
• Experience safety reporting to regulatory authorities in Spanish speaking LATAM countries;
• Drug safety experience;
• Knowledge of applicable safety reporting guidelines;
• Strong attention to detail;
• 3 years of experience of working within drug safety; and
• Fluency in Spanish & English

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

• Flexible work environment
• Competitive compensation and benefits package
• Competitive PTO packages
• Structured career paths with opportunities for professional growth
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives

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.