Available Positions

Drug Safety Associate at Pharmaceutical Company in New York, New York, United States —

  • Pharmaceutical
  • Pharmaceutical Company
  • New York, New York, United States
  • 8/13/19

Job ID: 60535

Job Description

·  Develop a thorough knowledge of company products and clinical programs associated with these products

·  Coordinates and performs adverse event data entry, coding and assessment of adverse events, query suggestions

·  Accurately and within the defined timeframe processes clinical trial cases in the ARISg safety data base

·  Maintains the ARISg safety database on a weekly/monthly basis to ensure the data is accurate and up to date

·  Prepares, tracks and follows up on case queries

·  Performs the coding reviews for adverse events, medical history and concomitant medications from the ongoing clinical trials

·  Assists in resolving database discrepancies and SAE reconciliations from ongoing clinical trials

·  Acts as the Safety Lead for ongoing clinical development programs

·  Performs as a backup for case book-in and conducts the case archiving

·  Provides peer review quality control for ICSRs from Clinical trial cases assigned

Qualifications

·  Bachelor’s degree, or higher in nursing or pharmacy;

·  Minimum of 2 years of relevant experience, working with a safety database (ARISg preferred);

·  Minimum of 2 years of relevant experience on MedDRA and WHO-DD coding

·Proven ability in processing of clinical safety data for investigational products in the biopharmaceutical industry

·Demonstrated oral, written and interpersonal communication skills, with writing expertise in the scientific or medical field highly preferred

·Demonstrable organizational and time management skills with the ability to triage and manage multiple responsibilities with a high degree of self-motivation and accountability

·Familiarity with key safety regulations such as FDA, ICH, and EMA

·Proven knowledge of Microsoft Office Suite applications, specifically Word, Excel and PowerPoint

·Proven attention to details

·Must possess the ability to work effectively in a fast-paced environment, and deal effectively with changing priorities.

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