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Snr Drug Safety Specialist

Newark Metro Area, NJ

Post Date: 08/03/2017 Job ID: JN -082017-19703 Job Type: Clinical
Drug Safety Specialist - BSN/RN, PharmD, related health care industry experience required
Experience in writing high quality case narratives particularly for clinical trials.
Experience assessing serious case reports; SAEs
The Drug Safety Specialist is responsible for:
Ensuring that individual Adverse Event Case Reports are evaluated, investigated and accurately documented
  • Support the triage of cases conducted by Senior Specialist as needed
  • Execute QC on key fields of serious cases
  • Update key fields in ARISg based on QC, as needed
  • Execute case assessment (review events, determine labeledness, identify co-manifestations, review coding, determine causality)
  • Produce Create clear concise clinical case narratives
  • PSURs

***ARISg or ARGUS experience highly desired.
***MUST be able to produce a high volume of high quality cases within a busy Drug Safety work environment. Healthcare professionals are preferred.

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