Pharmacovigilance Physician

Job Description

Key Role:
Apply pharmacovigilance physician expertise to clients and teams in the Federal Health space. Leverage scientific and technical expertise to ensure that all activities are compliant with industry safety standards, processes, and requirements. Apply scientific expertise in medical safety to consolidate written findings, detailed analysis, and best practices to avoid adverse events. Review and contribute to annual reports as a pharmacovigilance subject matter expert of safety and best practices. Demonstrate leadership expertise to bring together stakeholders to contribute to working group meetings focused on developing safety protocol documents. Provide ongoing safety surveillance and conduct reviews of current clinical protocols and products while ensuring all activity is compliant with the latest safety standards and protocols.

Basic Qualifications:

-Experience with the Food and Drug Administration (FDA) safety protocol and processes, product life cycle monitoring, and benefit risk management activities

-Experience with scientific writing

-Experience with leading technical project teams

-Experience with working for US Federal health clients

-Ability to review many technical documents and synthesize into written deliverables

-Ability to obtain a security clearance

-MD degree required with active licensure in the state of Maryland

Additional Qualifications:

-Experience with health data sets, including electronic health records, clinical data, and claims data a plus

-Experience in the Army with US Army Medical Research and Development Command (USAMRDC)

Clearance:

Applicants selected will be subject to a security investigation and may need to meet eligibility requirements for access to classified information.

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