Experienced Clinical Safety Coordinator (Drug Safety)

Medpace, Inc.; Buenos Aires; Presencial; ARS 97.979.000 - 135.663.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Office-based culture

Occasional WFH after training

Health benefits

Retirement plan

PTO benefits

Company social events

Descripción de la vacante

Medpace, Inc. is seeking a full-time, office-based Clinical Safety Coordinator to join our growing LATAM team in Buenos Aires. You will contribute to pharmacovigilance processes and collaborate with global cross-functional partners to ensure safety reporting and compliant documentation.

The role requires a life sciences degree, GCP knowledge, and fluency in Spanish and English, with 3 years of drug safety experience. This position offers on-site work with opportunities for professional growth.

Formación

• Bachelor's degree in life science is required.
• Fundamental knowledge of GCP guidelines and medical terminology.
• Knowledge of EDC systems and other clinical databases.
• Experience safety reporting to regulatory authorities in Latino LATAM Spanish-speaking countries.
• Drug safety experience.
• Knowledge of applicable safety reporting guidelines.
• Strong attention to detail.
• 3 years of experience in drug safety.
• Fluency in Spanish & English.

Responsabilidades

• Oversight of submission of safety reports to authorities in regulatory timelines.
• Regular interaction with Clinical Operations, Data Management and Regulatory Submissions.
• Draft study-specific safety documents as required.
• Work in a global team to distribute safety reports globally.

Conocimientos

Fluency in Spanish & English

Drug safety experience

Knowledge of GCP

Attention to detail

Safety reporting guidelines knowledge

Educación

Bachelor's degree in life science

Herramientas

EDC systems

Clinical databases

Descripción del empleo

Job Summary

Our Latin American activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical SafetyCoordinator to join our team! This position plays a key role inthe pharmacovigilanceprocess 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) providing phase l-lV 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 the advancement of clinical research. We leverage in-country regulatory and therapeutic expertise across all major therapeutic areas including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries.

Why Medpace?

When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration.

Purpose-Driven Work

• Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence

Collaborative Culture

• Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.
• Leadership throughout Medpace is both accessible and approachable

Continuous Growth & Development

• Office based environment with on-site mentors
• Defined career paths with clear advancement opportunities
• Industry renowned onboarding and training programs designed to accelerate professional development
• Ongoing training and continuous learning opportunities throughout your career
• An environment that encourages employees to influence change, contribute ideas, and grow quickly

Other Employee Benefits

• Competitive compensation programs that recognize and reward performance
• Comprehensive health, wellness, retirement, and PTO benefits
• Office based culture with occasional WFH that provides flexibility for eligible positions after training
• Company-sponsored social events

Please note benefits may vary based on country.