Senior Medical Director, Patient Safety & Risk Management at Aimmune Therapeutics, Inc in Remote
Summary:
Reporting to the VP, Patient Safety & Risk Management (PSRM), the Senior Medical Director will provide hands-on medical monitoring and strategic leadership for assigned investigational and marketed products. This individual will help build the PSRM group by providing medical and strategic input to support institution of new processes and technologies. The Senior Medical Director, PSRM, must act as the deputy for the VP, GPSRM when necessary.
Responsibilities:
o Leads and directs all aspects of the pharmacovigilance activities for assigned investigational and marketed products including signal detection, signal analysis, communication, and mitigation of potential safety risks o Responsible for developing, executing and maintaining risk management strategy for assigned products o Authors, reviews and provides input for drug-safety related regulatory reports and clinical study documents including periodic aggregate reports, case series analyses, regulatory submission documents o Contributes to the development of internal processes including SOPs, Guidelines and Work Instructions o Acts as medical and scientific subject matter expert for the pharmacovigilance capabilities build of a growing function within the Company Qualifications o MD or foreign equivalent o Minimum 10 years of experience in pharmacovigilance in pharmaceutical/biotech company. Experience can be substituted with work in Academic research or in other areas of the pharmaceutical industry Preferred Experience, Special Skills, Knowledge:
o Excellent understanding of global PV regulatory environment with working knowledge of international regulations, initiatives, standards, Good Pharmacovigilance Practices (GVP), and Good Clinical Practice (GCP) o Experience in signal detection, including external databases such as FAERS, Vigibase, Eudravigilance o Skilled in performing signal analyses and case series analyses o Experience in developing risk management strategies and writing risk management plans o Excellent knowledge of drug development process o Strong leadership and communication skills o Minimum 3 years clinical practice experience preferred About Aimmune Therapeutics, Inc.
Salary Range:
$250K -- $500K+
Minimum Qualification
Medicine, Healthcare ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
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