Sumitomo Pharma America
Pharmaceutical
SeniorMedicalDirector,PVRM
“Senior Medical Director, PVRM at Sumitomo Pharma America. Skills: Pharmacovigilance, Risk Management, Medical Safety. Lead safety strategy. Lead ongoing safety monitoring”
Industry & Context.
Analytical skills
Ability to travel, Periodic on-site meetings
What They're Looking For.
Must Have
Medical Degree (MD), 12+ years relevant experience, Experience with NDALA/MAA submission
Nice to Have
Experience in Oncology, Experience in Neurology, Prior people management experience
What You'll Do.
Lead ongoing safety monitoring
Provide PVRM Medical representation
Prepare and present safety data
Contribute/author safety sections
Contribute to preparation of Company Core Data Sheets
Contribute to preparation of Locally labels
Contribute to preparation of Risk Management Plans
Medical review of Aggregate Reports
Handle Health Hazard Evaluations
Handle Ad-Hoc Regulatory safety inquiries
Perform aggregate safety data review
Participate in literature evaluation
Participate in investigator site training
Participate in continuing education
Participate in audits
Participate in inspections
Develop and maintain relationships
Maintain working knowledge of regulations
Support PVRM ad-hoc projects
Ensure compliance with regulations
Ensure compliance with internal SOPs
Foster a culture of patient first
Ensure timely review of ICSRs
Ensure quality review of ICSRs
Assess ICSRs for seriousness
Assess ICSRs for expectedness
Assess ICSRs for safety narratives
Assess ICSRs for adverse event coding
Assess ICSRs for causality statements
How You'll Work.
Team & Collaboration
Product specific teams; Clinical study team meetings; Governance committees; Cross-functional teams
Communication Scope
Oral communication; Written communication
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