Base: $10; bonus/equity: $20; benefits: not specif...
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Medical review of icsrs
Analysis of similar events (aose)
Expedited reporting and unblinding
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Summit Therapeutics Inc. is seeking a Director, Safety Physician to oversee pharmacovigilance activities for investigational and marketed products, focusing on ensuring patient safety during clinical trials. The ideal candidate will have an MD/DO with at least 8 years of experience in the field, particularly within oncology, and possess strong analytical and leadership skills.
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Job Summary
The Safety Physician Director will be responsible for investigational and marketed product pharmacovigilance activities, including medical review of ICSRs, strategic input for adverse event monitoring and signal detection.
Key responsibilities include ensuring global pharmacovigilance regulatory requirements are met and safeguarding patients enrolled in trials or administered products.
The role involves leading or contributing to safety information presentations to various committees and stakeholders, and mentoring junior medical safety reviewers.
Matching Summary
Match Score: 75
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Summit Therapeutics Inc. is seeking a Director, Safety Physician to oversee pharmacovigilance activities for investigational and marketed products, focusing on ensuring patient safety during clinical trials. The ideal candidate will have an MD/DO with at least 8 years of experience in the field, particularly within oncology, and possess strong analytical and leadership skills.
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Salary
Base: $10; Bonus/Equity: $20; Benefits: Not specified
Skills & Requirements
Must-have
medical review of ICSRs
Analysis of Similar Events (AOSE)
expedited reporting and unblinding
safety information presentation
PV vendor medical reviewer interaction
aggregate safety data review
signal detection
safety database reconciliation
Reference Safety Information (RSI) development
Health Authority Inspection readiness
Nice-to-have
passion for excellence
purposeful urgency
collaboration
commitment to people
touch and help change lives
Key Requirements
MD/DO or international equivalent
8+ years relevant work as a safety physician
Clinical knowledge of oncology
Proficiency in technical safety systems
Strong knowledge of global safety reporting and pharmacovigilance requirements