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Drug Safety Coordinator

  • Ref: 283908
  • Type: Direct Hire
  • Location: Stamford, CT
  • Industry: Biopharmaceuticals / Biotherapeutics
  • Job Level: Experienced Non-Manager
  • Pay: $75,000.00 - $80,000.00

Opportunity Description

Drug Safety Coordinator needed for a direct hire in Stamford, CT in the biopharmaceuticals industry. As the Drug Safety Coordinator, you will be in charge of managing and tracking receipt of initial and follow-up reports from study sites. The applicant must be able to multi-task and have great interpersonal skills. 

Company Information

Our client is a growing biotechnology company that only strives to make leaps forward in the future of their industry. As a member of this team, you will be a part of a core group that works hard and is dedicated to the progression of their organization. 

Job Duties

  • 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.

Education

  • Bachelor Degree in nursing, pharmacy or a health/science field.

Experience & Skills Required

  • 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.
  • Experience with use of Adobe Acrobat (Reader and Writer), Microsoft XL and Microsoft Word.
  • 3-5 years of relevant database case processing experience.