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Experienced Clinical Safety Coordinator (Drug Safety)

Medpace
Medpace
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, 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.