Job details
Job type full-time
Full job description
Agilent inspires and supports discoveries that advance the quality of lifeWe provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertiseAgilent enables customers to gain the answers and insights they seek - so they can do what they do best: improve the world around usInformation about agilent is available at www.agilent.com.
The vigilance medical safety physician (msp) has the responsibility for determining medical and scientific relevance within the context of agilent’s product’s safety profilesThe msp will support the vigilance group in a variety of activities which include medical assessments of patient safety in regard to non-conformances or product malfunctions and will assist in preparing/evaluating safety data, and other duties as assigned.
Ability to interpret, summarize and present clinical data and other complex information in written and oral presentations to leadership and safety governance including aggregate reporting
Understanding of fda and eu regulations and guidelines to independently strategize, author and review safety deliverables
Robust medical interpretation of safety data with oversight
Provide medical clinical expertise for assessment of in vitro diagnostics incidents
Provide medical safety input for product quality
Communicate any safety issues to the quality review board
Provide medical responses to safety-related queries to health authorities and health care professionals
Initiate customer concern of safety issues, including those requiring a field action
Analyze and interpret data from multiple sources (complaints, non-conformity reports, clinical trials, literature, etc
Utilize medical judgment to resolve impact of the safety issue on the product’s benefit-risk profile (provide input for safety reviews and advise on the appropriate strategy for benefit-risk evaluation)
Participate in product risk management boards
Lead authoring of vigilance assessments and health hazard assessments
