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Responsible for the collection, data entry, routing, follow-up, and timely reporting/submission of safety information related to drug products from a variety of sources (clinical trial, spontaneous, literature), both U.S. and foreign, in compliance with SOPs, US regulations, and international ...

Job Description

Responsible for the collection, data entry, routing, follow-up, and timely reporting/submission of safety information related to drug products from a variety of sources (clinical trial, spontaneous, literature), both U.S. and foreign, in compliance with SOPs, US regulations, and international regulations.  This position is also responsible for self-initiated quality review within each distinct process step.

Routine safety surveillance/signal detection

Labelling

Medical literature review

Contribution to/Creation of regulatory responses 

Review of outsourced reports

Required:

  • Consumer health background
  • Global pharmacovigilance experience
  • Medical writing/literature review experience