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Experienced Clinical Safety Coordinator

3+ years
Not Disclosed
10 Jan. 13, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Clinical Safety Coordinator (Latin America)

Location: Office-based, Latin America
Department: Pharmacovigilance
Company: Medpace


Job Summary

Medpace is expanding its Latin American operations and is looking for a full-time Clinical Safety Coordinator to join the team. In this role, you'll play a critical part in the pharmacovigilance process, ensuring the safety and regulatory compliance of clinical trials. This position offers an exciting opportunity to apply your expertise, while contributing to projects that are vital to Medpace's success.


Responsibilities

  • Oversee the submission of safety reports to Competent Authorities and Ethics Committees in compliance with regulatory timelines.
  • Collaborate with internal departments globally and locally, such as Clinical Operations, Data Management, and Regulatory Submissions.
  • Draft study-specific safety documents as required.
  • Work with a global team to distribute safety reports across regions.

Qualifications

  • Education:
    • Bachelor's degree in Life Sciences or a related field.
  • Experience:
    • At least 3 years of experience working in drug safety.
    • Familiarity with safety reporting to regulatory authorities in Spanish-speaking LATAM countries.
    • Experience with Electronic Data Capture (EDC) systems and clinical databases.
  • Knowledge:
    • Strong understanding of Good Clinical Practice (GCP) guidelines and medical terminology.
    • Knowledge of safety reporting guidelines.
    • Proficiency in Spanish (fluency required).
  • Skills:
    • Strong attention to detail and ability to manage safety reports effectively.

About Medpace

Medpace is a global clinical contract research organization (CRO), offering Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Medpace is headquartered in Cincinnati, Ohio, with over 5,000 employees across 40+ countries.

We focus on accelerating the development of safe and effective medical therapeutics, leveraging local regulatory expertise across key therapeutic areas including oncology, cardiology, metabolic disease, endocrinology, and more.


Why Join Medpace?

People. Purpose. Passion.

  • Impact patient lives through advanced clinical trials.
  • Collaborate with a global team in a fast-growing and dynamic environment.
  • Contribute to projects that improve the future of medicine.

Medpace Perks

  • Flexible work environment.
  • Competitive compensation and benefits.
  • Generous PTO packages.
  • Career growth opportunities with structured professional development.
  • Company-sponsored events, wellness programs, and more.

Awards & Recognition

  • Recognized by Forbes as one of America’s Most Successful Midsize Companies (2021–2024).
  • Winner of CRO Leadership Awards for expertise and quality.

What to Expect Next

A Medpace team member will review your qualifications and contact you with next steps if your profile is a fit for the role.

Medpace is an Equal Opportunity Employer committed to diversity and inclusion.