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Experienced Clinical Safety Coordinator

3+ years
Not Disclosed
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 Clinical Safety Coordinator to join our office-based team. This role is vital to the pharmacovigilance process, requiring close collaboration within a global team to support safety reporting and regulatory compliance. If you are looking for a dynamic opportunity to grow your expertise and make a significant impact in drug safety, this position is ideal for you.


Key Responsibilities

  • Manage the submission of safety reports to Competent Authorities and Ethics Committees, ensuring compliance with regulatory timelines.
  • Collaborate with global and local internal departments, including Clinical Operations, Data Management, and Regulatory Submissions.
  • Draft study-specific safety documents as needed.
  • Work within a global team to ensure the timely distribution of safety reports.

Qualifications

  • Bachelor’s degree in Life Sciences or a related field.
  • Strong understanding of Good Clinical Practice (GCP) guidelines and medical terminology.
  • Experience with Electronic Data Capture (EDC) systems and clinical databases.
  • Proven track record in safety reporting to regulatory authorities within Spanish-speaking LATAM countries.
  • Minimum of 3 years of drug safety experience.
  • Familiarity with applicable safety reporting guidelines.
  • Excellent attention to detail.
  • Fluency in Spanish.

Why Join Medpace?

Purposeful Work
Make a meaningful impact by advancing global healthcare and improving the lives of patients worldwide.

Supportive Culture

  • Flexible work environment and structured career paths for professional growth.
  • Competitive compensation and benefits packages.
  • Collaborative team environment with employee appreciation initiatives.

Community and Wellness

  • Employee health and wellness programs.
  • Opportunities for community involvement with nonprofit organizations.

About Medpace
Medpace is a global full-service clinical contract research organization (CRO) specializing in Phase I-IV trials. We deliver innovative solutions for the biotechnology, pharmaceutical, and medical device industries. Headquartered in Cincinnati, Ohio, we operate in over 40 countries and are committed to improving lives through safe and effective medical therapeutics.


Awards & Recognition

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