Medical Director, Pharmacovigilance

Recruiter
AbbVie
Location
North Chicago, Illinois
Posted
Sep 11, 2019
Closes
Sep 13, 2019
Ref
526800f496ff
Organization Type
Corporate
  • Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance
  • Safety surveillance for pharmaceutical / biological / drug -device combined products
  • Contribute to the authorship of key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans
  • Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
  • Analyze and interpret aggregate safety data and communicate these analysis and interpretation to cross-functional teams
  • Ability to effectively write, review and provide input on technical documents
  • Lead the strategy for periodic reports (PSUR's, PADER's etc.)
  • Oversight of safety surveillance and pharmacovigilance activities for products in clinical trials and post marketing
  • Lead and implement risk management strategy for assigned products


  • MD / DO with 2+ years of residency with patient management experience and Master Public Health is preferred in addition to MD / DO but not required
  • 2 - 4 years of Pharmacovigilance experience in the pharmaceutical industry
  • Effectively analyze and guide analysis of clinical data and epidemiological information
  • Effectively present recommendation / opinions in group environment
  • Write, review and provide input on technical documents
  • Self-starting and can work independently
  • Work collaboratively and lead cross-functional teams