Job Details

  • Title: Drug Safety Specialist
  • Code: RCI-03127
  • Location: Waltham Massachusetts (MA) 02451
  • Posted Date: 10/14/2020
  • Duration: 2 Months
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  Job Description

Responsible for the collection, data entry, routing, follow-up, and timely reporting/submission of safety information (including expedited and aggregate reports) related to drug products from a variety of sources (clinical trial, spontaneous, literature) in compliance with SOPs and regional & international regulations.

This position is especially important in light of the approval and marketing of products and the number and diversity of clinical trials. Authorities conduct periodic, detailed audits to ensure integrity of AE processing, thoroughness of documentation, accuracy of results, and timeliness of reports.

This position is also responsible for self-initiated quality review within each distinct process step.

Years of Experience: 3 - 6 Years PV exposure

Preferred, but not required:
• Medical/Nursing/Pharmacy background
• Sharepoint/Microsoft tools like outlook, PowerPoint and excel/general technical and computer skills
• Safety database experience
• Experience in organizing and conducting Safety governance/Regulatory Affairs meetings Additional Skills:
Language: English (Speak, read, Write)

Minimum Degree Required: Bachelor’s Degree