Sr. Manager or Associate Director Drug Safety
Array BioPharma - Boulder, CO

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Summary:

This key position in the Drug Safety group is responsible for managing and overseeing the company’s drug safety reporting process. This person will supervise and mentor others in Drug Safety and will focus on efficient, accurate and timely reporting of adverse events. This person will also play an important role representing Drug Safety in interactions with clinical, scientific and regulatory groups at Array.

Responsibilities:
  • Responsible for reviewing, summarizing and interpreting medical safety clinical data in a timely fashion
  • Responsible for compliance related medical assessments
  • Assists with developing custom reports to assess safety data
  • Manages the reporting activities for the drug safety program
  • Leads, manages and mentors the Drug Safety team
  • Primary responsibility as administrative lead for managing the Drug Safety electronic reporting system
  • Authors new and revised SOPs/WIs for Drug Safety
  • Completes AE and Concomitant medication coding reviews on a periodic basis and as requested by Clinical Data Management
  • Participates in preparing and supports development and execution of risk management plans
  • Plays a key role in the development and implementation of a drug safety strategy
  • Participates in preparing and managing medical safety documents submitted to the regulatory authorities
  • Reviews protocols, IBs, and submissions to ensure procedural compliance and to assess the medical content for accuracy
  • Collaborates with other departments to ensure appropriate collection and handling of safety data
  • Interacts with senior management to report on project or program milestones
  • Provides strategic or operational input on project teams
  • Drafts safety sections and/or templates for various documents, as requested or required
  • BA or BS in Heath Science required; PharmD or MPH in Epidemiology desired
  • 7 years of experience in drug safety (level determined by experience)
  • 4 years of experience in oncology in the biotech/pharmaceutical industry
  • Experience supporting regulatory submissions (Safety Summaries, Risk Management Plans)
  • International Drug Safety reporting experience
  • Experience supporting regulatory submissions and strong knowledge of domestic and international drug safety regulations
  • Excellent scientific, clinical and analytical base knowledge
  • Significant experience working with study protocols, case report forms, investigator brochures and participation on IND annual reports
  • Eudravigilance certification desired
  • AE and Concomitant Medication coding experience and/or certification desired
Array BioPharma Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule drugs to treat patients afflicted with cancer. We offer an excellent compensation package including a competitive salary, company ownership and comprehensive benefits.

Array is an equal opportunity employer and drug free workplace.. .

Array BioPharma - 20 months ago - save job - block
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