Key skills
Statistical AnalysisLeadershipRisk ManagementSales
About this role
Role Overview
- Serve as the safety expert of the assigned product(s) within the Rare Disease portfolio
- Establish the strategy, direction, and priorities of pharmacovigilance activities
- Lead the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC)
- 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
- Inspection Readiness
- Domestic and International travel up to 10%
Requirements
- MD or DO degree from an accredited medical school AND 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.
Benefits
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
- group medical, dental and vision coverage
- life and disability insurance
- flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models, including remote and hybrid work arrangements, where possible