Medical Director, Pharmacovigilance

Lake County, IL, US
Oct 11, 2019
Required Education
Position Type
Full time
  • 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 analyses and interpretation to cross-functional teams.
  • Ability to effectively write, review and provide input on technical documents.
  • Be responsible for 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 a 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