Global Safety Officer (GSO), Global Safety Medical Director - Obesity, US - Remote

Role Summary

Global Safety Officer (GSO), Global Safety Medical Director - Obesity, US - Remote

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
• Inspection Readiness
• Travel: Domestic and International travel ~10% may be required

Qualifications

• Basic Qualifications:
  • 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
• Preferred Qualifications:
  • 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
  • Expertise in Obesity/Cardiovascular therapeutic area
  • Leadership experience within the safety profile of products assigned with cross-functional team members

Skills

• Safety signal assessment
• Pharmacovigilance and risk management
• Cross-functional collaboration
• Regulatory filings and safety documentation
• Safety data analysis and reporting

Education

• Medical degree (MD or DO) required; residency completed as specified

Additional Requirements

• Travel: Domestic and International travel ~10% may be required