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Clinical Safety Coordinator - Pharmacovigilance / Drug Safety

1-2 years
Preferred by Comapny
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: Clinical Safety Coordinator - Pharmacovigilance / Drug Safety

Location: Singapore
Department: Clinical Safety
Job Requisition ID: 9542


About Medpace

Medpace is a full-service clinical contract research organization (CRO) specializing in Phase I-IV clinical development services for the biotechnologypharmaceutical, and medical device industries. With a mission to accelerate the development of safe and effective therapeutics, Medpace operates in 40+ countries, employing over 5,000 professionals worldwide.


Role Overview

Medpace seeks a Clinical Safety Coordinator for its Singapore office. This full-time, office-based role supports the Clinical Safety Manager in ensuring high-quality pharmacovigilance and drug safety deliverables. As a key contributor to the clinical safety team, you’ll engage in essential safety tasks, ensuring compliance and timely project execution.


Key Responsibilities

  • Project Coordination:

    • Collaborate with the Clinical Safety Manager to meet project deliverables.
    • Assist in the preparation of clinical safety documents.
  • Safety Reporting:

    • Collect, process, and track Serious Adverse Event (SAE) reports and related clinical event documents.
    • Generate and track study report safety narratives.
    • Perform safety submissions of expedited/periodic reports in SingaporeTaiwan, and China.
  • Safety Surveillance:

    • Coordinate activities such as lab reviews and trend analyses.
    • Create Investigator Safety Letters and distribute them to health authorities.

Qualifications

  • Educational Background:

    • Bachelor’s degree in health or life sciences.
  • Experience:

    • At least 1 year of clinical safety experience or 2 years in pharmaceutical research.
  • Skills & Expertise:

    • Proficiency in Good Clinical Practice (GCP) guidelines.
    • Excellent time management skills to meet tight deadlines.
    • Proficiency in Microsoft Office and experience with safety databases.
    • Strong attention to detail and ability to work both independently and within a team.

Why Join Medpace?

Singapore Perks & Benefits

  • Flexible work environment.
  • Competitive compensation and benefits packages.
  • Generous PTO policies.
  • Structured career growth opportunities.
  • Employee wellness and appreciation initiatives.

Recognition & Awards

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

How to Apply

Submit your application online under Job Requisition ID 9542 through the Medpace Career Portal.


Join Medpace today and contribute to advancing global healthcare through innovation and safety excellence.