Director- Drug Safety

Role & Responsibilities
• Lead global medical review and device safety pharmacovigilance operations
• Oversee in-line medical assessment of ICSRs for expectedness, causality and reportability
• Ensure compliance with global PV, ICH, and medical device safety regulations
• Act as SME for audits, inspections and regulatory interactions
• Lead and manage in-house and outsourced PV medical review teams
• Oversee first-line signal detection and escalation of safety risks
• Maintain KPIs, quality metrics and compliance dashboards
• Drive process automation and PV innovation initiatives
• Support regulatory responses, inspections and CAPA management
• Collaborate cross-functionally with Clinical Development, Research and Global Safety teams

Qualifications & Experience
• MD / DO / PhD or equivalent medical degree
• Minimum 7 years pharmacovigilance / clinical industry experience
• Minimum 5 years leadership and people management experience
• Strong expertise in global PV regulations and ICSR lifecycle
• Experience in medical device safety monitoring and vendor oversight
• Cross-cultural global team collaboration experience

Skills
• Advanced medical review and safety assessment expertise
• Regulatory compliance and audit readiness
• Leadership, stakeholder management and decision-making
• Metrics, KPIs and quality governance

About the Company
• Organon is a global $6.5B healthcare company focused on Women’s Health, biosimilars and established medicines