Hybrid Associate Director, Signal Detection Scientist

Posted 1 hour ago

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About the role

  • Lead signal detection strategies for monitoring safety signals in pharmaceutical products. Collaborate with cross-functional teams to assess and evaluate post-marketing safety data.

Responsibilities

  • Lead the implementation of the Signal Management Group aggregate surveillance strategies for proactive and systematic detection and evaluation of new safety signals and emerging trends
  • Develop and implement product-specific surveillance plans
  • Perform post-marketing signal detection activities, including signal validation
  • Participate in communication of emerging signals in forums, such as the Product Team Meetings and Safety Management Team Meetings
  • Develop strategies for signal evaluation, including providing guidance on data sources and methods of analysis
  • Conduct systematic reviews of aggregate data with a focus on spontaneous adverse event reports
  • Prepare reviews of topics and summary analysis reports of safety data, with minimal guidance
  • Work with key customers and business partners (Medical Safety Officers, Safety Scientists, and other Safety Physicians) in developing and implementing product-specific surveillance plans

Requirements

  • Bachelor’s Degree required
  • Advanced Healthcare-related Degree (e.g., RN, BSN, PharmD) with 3+ years industry experience in pharmacovigilance/drug safety or related area
  • 1+ year of clinical/patient-care experience highly preferred
  • Understanding of global health authority regulations and guidance surrounding the processing, reporting, and evaluation of adverse events
  • Understanding single case medical assessment, post-marketing aggregate adverse event data reviews, evaluations of drug safety issues
  • Ability to lead projects
  • Skillful in presenting complex data in a concise and understandable scientific manner
  • Ability to thrive in a global, matrix environment – able to handle high workload and critical issues
  • Up to 10% travel – Domestic & International

Benefits

  • 120 hours vacation per calendar year
  • 40 hours sick time per calendar year
  • 13 days holiday pay per calendar year
  • 480 hours parental leave within one year of the birth/adoption/foster care of a child
  • 240 hours bereavement leave for an immediate family member
  • 80 hours caregiver leave in a 52-week rolling period
  • 32 hours volunteer leave per calendar year
  • 80 hours military spouse time-off per calendar year

Job title

Associate Director, Signal Detection Scientist

Job type

Experience level

Senior

Salary

$137,000 - $235,750 per year

Degree requirement

Bachelor's Degree

Location requirements

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