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Director, Drug Safety (MD required)

  • Job type: Permanent
  • Location: Parsippany
  • Salary: $180000 - $220000 per annum
  • Job reference: kyrch
  • Sector: Clinical, EPM Scientific
  • Date posted: 11/07/2017
Director, Drug Safety (MD required)

A growing Life Sciences (Pharmaceutical AND Medical Device) company with International presence is looking for a Director, Drug Safety to join their rapidly expanding team! They are expanding their PV team and are looking for hands-on individuals to contribute to their growth and success!

The Director, Drug Safety will have the following responsibilities:

The Director, Drug Safety will have an MD and be responsible for supporting the Global Head, Pharmacovigilance. They will have experience authoring safety and periodic reports such as PADER, PBRER, DSUR, RMP as well as using safety databases. The Director, Drug Safety will provide medical review of AE and they will be involved with clinical trials, signal detections, and understand the submissions. They will work in all phases of the product life-cycle.
  • Perform signal detection
  • Process aggregate reports on a Global level
  • Preform medical review on marketed/pre-marketed products and medical devices
  • MedRA coding
  • Draft PV SOPs
The ideal candidate will have the following skill set:
  • Medical Degree (MD)
  • Minimum of 7+ years industry experience
  • Strong knowledge FDA and other international regulations
  • Excellent communication skills
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