Experienced Clinical Safety Coordinator (Drug Safety)

3+ years

Not Disclosed

Remote - Europe

10 Nov. 22, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Clinical Safety Coordinator
Company: Medpace
Location: Latin America

Job Summary
Medpace is expanding its Latin American operations and is seeking a full-time, office-based Clinical Safety Coordinator. This role is integral to our pharmacovigilance process, working within a global team to support safety reporting and regulatory compliance. If you’re looking for a dynamic career where you can grow and leverage your drug safety expertise, this position is the perfect fit.

Key Responsibilities

Oversee submission of safety reports to Competent Authorities and Ethics Committees in compliance with regulatory timelines.
Collaborate regularly with internal departments, including Clinical Operations, Data Management, and Regulatory Submissions.
Draft study-specific safety documents as needed.
Support the global distribution of safety reports.

Qualifications

Bachelor’s degree in Science (BSc) or related field.
Strong knowledge of Good Clinical Practice (GCP) guidelines and medical terminology.
Familiarity with Electronic Data Capture (EDC) systems and clinical databases.
Proven experience in safety reporting to regulatory authorities in Spanish-speaking LATAM countries.
Minimum 3 years of drug safety experience.
Knowledge of applicable safety reporting guidelines.
Strong attention to detail and fluency in Spanish.

Why Join Medpace?

Purposeful Impact
Play a key role in advancing global healthcare and improving lives through clinical research.

Supportive Environment

Flexible work settings and a competitive benefits package.
Career growth opportunities through structured development pathways.
A collaborative, global team environment.

Community and Wellbeing

Employee health and wellness initiatives.
Regular employee appreciation events.
Opportunities for community involvement with local nonprofit organizations.

About Medpace
Medpace is a global clinical contract research organization (CRO) specializing in Phase I-IV trials. We deliver innovative solutions to the biotechnology, pharmaceutical, and medical device sectors. With operations in 40+ countries, we are dedicated to accelerating the development of effective medical therapeutics.

Awards & Recognition

Named one of America’s Most Successful Midsize Companies by Forbes (2021–2024).
Recipient of CRO Leadership Awards for quality, reliability, and expertise from Life Science Leader Magazine.

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Experienced Clinical Safety Coordinator (Drug Safety)

Job Description

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