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Risk Management Lead (Pharmacovigilance / PV / Drug Safety)

Risk Management Lead (Pharmacovigilance / PV / Drug Safety) - Cambridge, MA

A pharmaceutical company in Cambridge is looking for a risk management lead to join their team in Cambridge, MA. The risk management lead will act as the drug safety expert for assigned products and will be responsible for the development of REMS, DRMP's & RMP's. The risk management lead will also prepare project timelines, ensure documents adhere to regulatory requirements, and provide medical/safety input of pBRER, RMP, DSUR, etc. Strong candidates will have extensive experience within a drug safety / pharmacovigilance role at a pharmaceutical or biotechnology company.

Risk Management Lead (Pharmacovigilance / PV / Drug Safety) - Cambridge, MA

Requirements:

  • 2+ years of experience writing and preparing risk management documents, including Risk Management Plans, Pharmacovigilance Plans and Risk Minimization Plans or REMS for submission to regulatory agencies.
  • Previous drug safety / pharmacovigilance experience within an industry setting (pharmaceutical, biotech, CRO)
  • Advanced degree in a scientific discipline preferred
  • Strong Communication Skills
  • Proficient in Microsoft Office

If interested in exploring this opportunity further, please email your CV to myself at J.Segal(at sign)realstaffing.com

Sthree US is acting as an Employment Business in relation to this vacancy.