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Drug Safety Specialist

2+ years
Not Disclosed
10 Oct. 14, 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 seeking a full-time, office-based Clinical Safety Coordinator to join our Clinical Safety department in India. This role will focus on handling and processing adverse events from various sources, including clinical trials and post-marketing surveillance. If you're looking for an exciting career where you can leverage your expertise and further develop your skills, this opportunity is for you!

Responsibilities

  • Determine the plan of action for incoming calls
  • Collect, process, and track incoming adverse and serious adverse events
  • Write safety narratives
  • Report on various safety data
  • Collaborate with internal departments and clinical research sites to ensure compliance with safety processes

Qualifications

  • Bachelor’s degree in a healthcare-related field (Nursing, Pharmacy, Pharmacology, etc.)
  • Preferred clinical experience in Clinical Research, case processing, and post-marketing pharmacovigilance
  • Proficient in English
  • Strong knowledge of Microsoft® Office
  • Broad understanding of medical terminology
  • Excellent organizational and communication skills

About Medpace
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. With local regulatory and therapeutic expertise across major areas including oncology, cardiology, metabolic disease, endocrinology, and more, we are headquartered in Cincinnati, Ohio, and employ over 5,000 people in 40+ countries.

Why Choose Medpace?
People. Purpose. Passion. Make a difference tomorrow. Join us today.
Our work over the past 30+ years has positively impacted countless patients and families facing various diseases. The efforts we make today will improve lives for those living with illness 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
Medpace has been recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023, and 2024, and has received CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility.