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Clinical Safety Coordinator - Pharmacovigilance / Drug Safety

2+ years
Not Disclosed
10 Oct. 23, 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 Summary
We are currently seeking a full-time, office-based Clinical Safety Coordinator to join our team in the Singapore office. This role is essential for accomplishing tasks and projects that contribute significantly to the company’s success. If you are looking for an exciting career where you can utilize your expertise and further develop your skills, this is the opportunity for you!

Responsibilities

  • Collaborate closely with the Clinical Safety Manager to ensure that project deliverables are met.
  • Collect, process, and track serious adverse event (SAE) reports and clinical event documents.
  • Generate and track safety narratives for study reports.
  • Coordinate safety surveillance activities, including lab reviews and trend analyses.
  • Generate Investigator Safety Letters and distribute them to health authorities.
  • Assist in the preparation of clinical safety documents.
  • Perform safety submissions of expedited and periodic reports for Singapore, Taiwan, and China.

Qualifications

  • Bachelor’s degree in health or life sciences, with 1 year of clinical safety experience or 2 years of pharmaceutical research experience.
  • Proficient in a variety of clinical safety tasks as detailed in the responsibilities section.
  • Excellent time management skills with the ability to work under tight timelines.
  • Strong ability to interact well in a team environment while also being able to work independently and manage your workload.
  • Proficient in Microsoft Office and experienced in using safety databases efficiently.
  • Strong attention to detail.
  • Demonstrate comprehensive knowledge of Good Clinical Practice (GCP) guidelines.

Medpace Overview
Medpace is a full-service clinical contract research organization (CRO) that provides Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through a scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across major areas, including oncology, cardiology, metabolic disease, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ over 5,000 people across 40+ countries.

Why Medpace?
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families facing various diseases across key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

Medpace Perks

  • Hybrid work-from-home options (dependent on position and level)
  • Competitive PTO packages
  • Company-sponsored employee appreciation events
  • Employee health and wellness initiatives
  • Flexible work schedules
  • Competitive compensation and benefits package
  • Structured career paths with opportunities for professional growth

Awards

  • Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023, and 2024.
  • Continually honored with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility.

Join Medpace and be part of a mission that makes a difference!