Director, Global Safety Physician, Pharmacovigilance
Location: Norwood, Massachusetts
Title: Director, Global Safety Physician, Pharmacovigilance
Job Profile: 10710 – Director, Pharmacovigilance
Location: Cambridge, MA
Reports to: Vice President, Pharmacovigilance
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.