🪄 Skills: LeadershipData AnalysisCross-functional Team LeadershipAgile methodologiesRisk Management
Requirements:
MD or DO degree from an accredited medical school
Completion of an accredited medical or surgical residency OR Clinical experience in either an accredited academic setting or private practice (including hospital based) setting
Product safety in the bio/pharmaceutical industry or regulatory agency
Expertise in Rare Disease therapeutic area, or clinical training.
Experience with marketed product safety; risk management
Experience with phase 1-3 clinical trials safety assessments and analyses
Drug Submission experience
Leadership experience of the safety profile of products assigned with cross-functional team members.
Responsibilities:
Validate safety signals and lead safety signal assessments
Develop and maintain Core Safety Information (core data sheet, core risks in informed consent forms, etc.)
Prepare/review core and regional risk management plans including additional risk minimization measures
Prepare/review safety sections of periodic aggregate reports
Provide safety input to protocols, statistical analysis plans, and clinical study reports
Prepare/review safety sections of new drug applications and other regulatory filings
Serve as safety expert on Evidence Generation Team for assigned products