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Director, Global Safety Physician, Pharmacovigilance


Location: Norwood, Massachusetts
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Title:                     Director, Global Safety Physician, Pharmacovigilance

Job Profile:         10710 – Director, Pharmacovigilance

Location:             Cambridge, MA

Reports to:         Vice President, Pharmacovigilance

 

The Role:

The Pharmacovigilance function maintains public confidence through globally compliant clinical safety and risk management for Moderna’s entire product portfolio including the mRNA-1273 vaccine from Phase 1 through Post Marketing.  The Global Safety Physician reports to Moderna’s Vice President, Pharmacovigilance and performs clinical trial safety evaluation, post marketing surveillance, periodic regulatory reporting, risk management/minimization, and external communication with cross functional partners.

 

Duties Include but are not limited to:  

  • Provide clinical and scientific leadership within the pharmacovigilance function.
  • Engage cross-functional internal workstreams including therapeutic area development, biostatistics, clinical operations, and regulatory affairs.
  • Engage with external organizations, key opinion leaders, and advisors
  • Guide the operations of contract research organizations
  • Perform case series analysis of adverse events and review of passive surveillance data mining signals of disproportionate reporting as well as safety issues from other sources
  • Lead clinical safety and benefit risk sections of regulatory documents and preparation for meetings with regulatory and public health authorities as well as advisory committees
  • Provide clinical input to the design of clinical trials, signal refinement/validation activities, post authorization studies, risk minimization, and risk communication

 

Here’s What You’ll Bring to the Table:

 

  • MD or non-US equivalent with residency training, board certification, and at least three years of clinical practice experience
  • Additional graduate training in public health, epidemiology, or statistics is preferred
  • Minimum two years’ experience in pharmacovigilance in an industry setting. Exceptional candidates from academic, regulatory, and clinical development settings will also be considered.
  • Proven ability to:
    • Collaborate within technical teams to deliver high-quality results within established timelines
    • Utilize technology supporting pharmacovigilance
    • Integrate concepts and guidelines from FDA, EMA, PMDA and other regulatory agencies, public health agencies and nongovernmental organizations, and clinical practice groups
    • Investigate new safety issues
    • Communicate medical product benefits and risks to regulatory and public health authorities as well as the public
  • Ability to thrive in a fast-paced environment while providing appropriate attention to detail
  • Excellent analytical, problem-solving, strategic planning, and interpersonal skills.

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