Senior Medical Director/Product Safety Team Lead (Oncology)

Lake County, IL, US
Apr 07, 2019
Required Education
Position Type
Full time
The primary job functions for this position include human safety surveillance related to pharmaceutical products and medical devices and risk identification and assessment. The analysis and interpretation of large amounts of safety data in specific therapeutic areas will be paramount, as will the written and oral communication of said analyses. The effective functioning of product safety teams is an important responsibility.
  • Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance
  • Responsible for 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
  • Effectively write, review and provide input on technical documents independently
  • Oversight and responsibility for leading 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
  • Responsible for implementing risk management strategies for assigned products
  • Proactively engaging, inspiring, coaching and mentoring team and colleagues

  • MD / DO with 2+ years of residency with patient management experience
  • 5 - 8 years of Pharmacovigilance experience in the pharmaceutical industry
  • Ability to lead cross-functional team in a collaborative environment
  • Fluency, both written and oral, in English
  • Evaluate and make independent decisions
  • Work collaboratively and lead cross-functional teams
  • Write, review and provide input on technical documents
  • Effectively analyze and guide analysis of clinical data and epidemiological information
  • Effectively present recommendations / opinions in group environment both internally and externally
  • Master Public Health is preferred in addition to MD / DO, not required

Equal Opportunity Employer Minorities/Women/Veterans/Disabled