Experienced Clinical Safety Coordinator

3-5 years

Preferred by Comapny

Mexico

10 Nov. 25, 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 Opportunity: Experienced Clinical Safety Coordinator

Location: Mexico City, Mexico
Department: Clinical Safety
Job Requisition ID: 9568

About Medpace

Medpace is a full-service clinical contract research organization (CRO) offering Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Headquartered in Cincinnati, Ohio, Medpace operates in 40+ countries with over 5,000 employees, focusing on therapeutic areas like oncology, cardiology, metabolic disease, endocrinology, CNS, and anti-viral treatments.

Role Overview

Medpace is seeking an Experienced Clinical Safety Coordinator to join our Mexico City team. This position plays a critical role in the pharmacovigilance process, ensuring safety reports are submitted in compliance with regulatory requirements. This full-time, office-based role involves global collaboration and direct involvement with internal departments and regulatory authorities in Latin America.

Key Responsibilities

Safety Report Oversight:
- Ensure timely submission of safety reports to Competent Authorities and Ethics Committees in compliance with regulatory timelines.
- Oversee submission processes to meet applicable regulatory standards.
Team Collaboration:
- Coordinate regularly with Clinical Operations, Data Management, and Regulatory Submissions teams both globally and locally.
Document Drafting:
- Prepare study-specific safety documents as needed, tailored to project requirements.
Global Safety Distribution:
- Work in a global team to ensure efficient distribution of safety reports worldwide.

Qualifications

Education:
- Bachelor's degree in Life Sciences or a related field.
Experience:
- At least 3 years of experience in drug safety.
- Familiarity with safety reporting guidelines and Electronic Data Capture (EDC) systems.
- Proven experience in safety reporting to regulatory authorities in Spanish-speaking LATAM countries.
Skills:
- Strong knowledge of Good Clinical Practice (GCP) guidelines and medical terminology.
- Exceptional attention to detail and organizational skills.
- Fluent in Spanish; proficiency in English is a plus.

Why Medpace?

Mexico City Perks & Benefits

Flexible work environment
Competitive compensation and benefits packages.
Generous PTO policies.
Career development with structured paths for professional growth.
Company-sponsored events that foster appreciation and collaboration.
Employee health and wellness initiatives.

Recognition & Awards

Named one of America's Most Successful Midsize Companies by Forbes in 2021, 2022, 2023, and 2024.
Awarded CRO Leadership Awards from Life Science Leader Magazine for expertise, quality, capabilities, reliability, and compatibility.

How to Apply

Submit your application in Spanish or English through the Medpace Career Portal under Job Requisition ID 9568.

Join Medpace to make a meaningful impact in global clinical research and pharmacovigilance.

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Experienced Clinical Safety Coordinator

Job Description

Job Opportunity: Experienced Clinical Safety Coordinator

About Medpace

Role Overview

Key Responsibilities

Qualifications

Why Medpace?

Mexico City Perks & Benefits

Recognition & Awards

How to Apply

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