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Drug Safety Specialist

2-5 years
Not Disclosed
15 June 19, 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, 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 Clinical Safety department in India. This position will be focused on the handling and processing of adverse events from all sources, including clinical trials and post marketing surveillance.

If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you!


Responsibilities

  • Determine plan of action for incoming calls;

  • Collect, process, and track incoming adverse and serious adverse events;

  • Write safety narratives;

  • Report on various safety data; and

  • Collaborate with internal departments and investigative clinical research sites to ensure compliance with safety processes.


Qualifications

  • Bachelor's degree in Healthcare related field; Nursing, Pharmacy, Pharmacology, etc 

  • Clinical experience or Clinical Research, case processing and Post marketing Pharmacovigilance experience is preferred;

  • Proficient English is required 

  • Proficient knowledge of Microsoft® Office;

  • Broad knowledge of medical terminology; and

  • Strong organizational and communication skills.


Medpace Overview

Medpace is a full-service clinical contract research organization (CRO). We provide 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 its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 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 who face hundreds of diseases across all 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 upon position and level)

  • Competitive PTO packages

  • Company-sponsored employee appreciation events

  • Employee health and wellness initiatives

  • Flexible work schedule

  • 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 recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility