Drug Safety Associate

Responsibilities:

  • Book-in and perform case processing of serious ICSRs and other qualified case reports in the safety database.
  • Manage and track receipt of initial and follow-up reports from study sites.
  • Monitor and track reports in the safety desk.
  • Manage and track report submission and distribution.
  • Manage and track compliance with Pharmacovigilance agreements.
  • Support aggregate report preparation activities.
  • Participate and support other functional unit activities as assigned.
  • Consistently apply case processing and archiving policies and practices per Company SOP.
  • Coordinate activities of Drug Safety Functional Unit.
  • Support and participate in inspection preparedness activities.

Desired Qualities:

  • Must have the ability to multi-task and work with minimal supervision.
  • Must be able to solve routine problems and to surface issues constructively.
  • Must be able to make basic decisions with understanding of the consequences.
  • Achieve personal objectives while meeting departmental standards of performance.
  • Receptive to acquiring new knowledge and learning new skills.
  • Highly organized with attention to detail.
  • Ability to work within deadlines and prioritize cases accordingly.
  • Great interpersonal skills.
  • Fluent in written and spoken English.

Desired Skills:

  • Safety database case processing experience, preferably Oracle Argus.
  • Basic knowledge of relevant FDA/GCP/ICH guidelines and AE reporting requirements.
  • Experience with MedDRA and WHODrug coding dictionaries.
  • Basic understanding of clinical trial operation.
  • Proficiency with use of Adobe Acrobat (Reader and Writer), Microsoft XL and Microsoft Word.

Desired Qualifications

  • Bachelor Degree in nursing, pharmacy or a health/science field.
  • 3-5 years of relevant database case processing experience.
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