Global Safety Medical Director, General Medicine

Role Summary

Global Safety Medical Director in the General Medicine therapeutic area, accountable for establishing a highly effective global safety organization in full compliance with worldwide regulations. Responsibilities span marketed products, biosimilar development, and early pipeline initiatives in Cardio-Metabolic diseases.

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 lead on Evidence Generation Team for assigned products
• Inspection Readiness

Qualifications

• Required: 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
• Preferred: Industry pharmacovigilance (PV) experience
• Product safety in the bio/pharmaceutical industry or regulatory agency
• Previous management and/or mentoring experience
• Board certification or equivalent training
• Leadership experience within the safety profile of products assigned with cross-functional team members