Sr Medical Director, Product Safety Lead

3 weeks ago

North Chicago, United States Capabilix Full time
Job DescriptionJob Description
  • Description:
    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
  • Lead, set the strategy and when appropriate write the key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses, 15 day aggregate reports.
  • Apply current regulatory guidance as appropriate for safety surveillance and authorship of safety documents
  • Analyze, interpret, and summarize aggregate safety data and communicate these analysis and interpretation to cross-functional teams and senior management
  • Independently write, review, and provide input on technical documents
  • Oversight and responsibility for leading the strategy as well as writing, when applicable, the key sections for periodic reports (e.g. PSURs,DSURs, PADERs and Safety sections of the IBs)
  • Lead and set the strategy, in collaboration with the development medical lead of study protocols and informed consents
  • Responsible for implementing risk management strategies for assigned product
  • Proactively engaging, inspiring, coaching and mentoring team members and colleagues
  • Opportunities to co-author publications and participate in initiatives to continue developing and growing as a safety leader

Significant Work Activities

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Frequent to continuous computer usage (greater or equal to 50% of the workday) is required

Qualifications

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

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