Director, Global Safety Physician, Pharmacovigilance (2)Apply Now
Location: Cambridge, Massachusetts 02139
Employment Type: Contract
Contract Length: 12+ months
Job Summary: The Pharmacovigilance function maintains public confidence through globally compliant clinical safety and risk management. This person will report to the Vice President, Pharmacovigilance and will perform clinical trial safety evaluation, post marketing surveillance, periodic regulatory reporting, risk management/minimization, and external communication with cross functional partners.
- 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
- 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.
Rich specializes in establishing new accounts and expanding current accounts, with a concentration in healthcare technology and general IT.
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